OsteoDetect helped clinicians spot wrist fractures on X-rays

In the reader study that FDA reviewed for OsteoDetect, 24 clinicians found distal radius fractures with 80.3% sensitivity when aided, against 74.7% unaided.

2
Benefit status
Reported
Evidence
Found by a court or regulator
Source published
Sources
2 publications
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Benefits

Benefit

Sensitivity rose from 74.7% to 80.3%

Awaiting review

Outcome identifiers

Unresolved

Not reviewedUnresolved

Category

Improved Task Accuracy

Awaiting review

Status

Reported benefit

Awaiting review

Beneficiary groups

Organizations.

Awaiting review

Beneficiaries

Unresolved

Not reviewedUnresolved

Reach

Unresolved

Not reviewedUnresolved

Distribution and access

Unresolved

Not reviewedUnresolved

Duration

Unresolved

Not reviewedUnresolved

Expected?

Yes

Awaiting review

Costs and harms

Unresolved

Not reviewedUnresolved

AI system

System

OsteoDetect

Awaiting review

Model

This is an explicit unresolved assignment: the sources on record do not settle this question.

Not reviewedUnresolved

Release

Unresolved

Not reviewedUnresolved

Provider

Unresolved

Not reviewedUnresolved

Role

Unresolved

Not reviewedUnresolved

Configuration

Unresolved

Not reviewedUnresolved

Inputs and outputs

Unresolved

Not reviewedUnresolved

Autonomy

Unresolved

Not reviewedUnresolved

Workflow

Clinicians reviewed the marked images together with the original images. Cases included PA and lateral wrist views of adults.

Awaiting review

Human oversight

Unresolved

Not reviewedUnresolved

Relation to AI

Every reader read every case with and without the software in a crossed design, so the gain is attributed to the software.

Awaiting review

AI contribution

Every reader read every case with and without the software in a crossed design, so the gain is attributed to the software.

Awaiting review

Measurement

Studies

Quasi-experimental. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Study design

Quasi-experimental. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Measurement

Fully crossed multi-reader multi-case study with a one-month washout; ground truth by three hand surgeons. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Setting and sample

24 clinicians of six types; 200 cases. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Measures

Reader AUC, sensitivity and specificity. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Comparison

Unaided reads by the same clinicians. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Results

AUC 0.840 to 0.889; sensitivity 74.7% to 80.3%; specificity 88.9% to 91.4%. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Additional value from AI

AUC difference 0.049 (95% CI 0.019 to 0.080). [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Limitations

Retrospective archived images; enriched case mix; no patient outcomes. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Denominators

200 aided and 200 unaided reads per clinician. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Materials for replication

None public. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Money

Kind of value

The kind of monetary value is unclear.

Not reviewedUnresolved

Amount

The monetary value is not established.

Not reviewedUnresolved

Currency and prices

The currency and price basis are unclear.

Not reviewedUnresolved

Period and unit

The period and unit of the monetary estimate are unclear.

Not reviewedUnresolved

Realization

Whether the monetary value was realized is unclear.

Not reviewedUnresolved

Recipients and payers

The recipients and payers are unclear.

Not reviewedUnresolved

Gross or net

Whether the monetary figure includes costs is unclear.

Not reviewedUnresolved

Included costs

The costs included in the estimate are unclear.

Not reviewedUnresolved

Comparison

The financial comparison is not established.

Not reviewedUnresolved

Method

The method used to calculate monetary value is unclear.

Not reviewedUnresolved

Return and payback

The return on investment or payback period is not established.

Not reviewedUnresolved

People and places

Participants

Developer: Imagen Technologies, Inc. Operator: Imagen Technologies (reader study with 24 clinicians).

Awaiting review

Jurisdictions

Benefit: United States. Developer: United States. Operator: United States.

Awaiting review

Ownership and control

Unresolved

Not reviewedUnresolved

Dependencies

Unresolved

Not reviewedUnresolved

Cross-border connections

Unresolved

Not reviewedUnresolved

Geopolitical implications

The geopolitical implications are unclear.

Not reviewedUnresolved

Follow-up

Conditions for replication

The patient is an adult with a suspected distal radius fracture. The clinician does not use the software output as the primary interpretation.

Awaiting review

Replication attempts

1 follow-up entry. Benefit recurred: 1.

Awaiting review

Later findings

Unresolved

Not reviewedUnresolved

Availability

Unresolved

Not reviewedUnresolved

Institutional decision

A relevant institutional decision has not been established.

Not reviewedUnresolved

Grounds

The grounds for an institutional decision are unclear.

Not reviewedUnresolved

Action and result

The result of an institutional decision is not established.

Not reviewedUnresolved

Success criterion

The criterion for a successful institutional decision is unclear.

Not reviewedUnresolved

Evidence

Source numbers

AIBD-0627-source-0001–0002

Awaiting review

Citations

Numbered references below.

Awaiting review

Language

Unresolved

Not reviewedUnresolved

Source relationships

Independent, Developer

Awaiting review

Original evidence

Unresolved

Not reviewedUnresolved

Access and versions

Unresolved

Not reviewedUnresolved

Supported findings

Unresolved

Not reviewedUnresolved

Evidence strength

Found by a regulator. Sources: one independent regulatory document and the makers' peer-reviewed study. The cited evidence includes no independent study or report. [1] [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [1] [2]

Missing evidence

Unresolved

Not reviewedUnresolved

Grades

Assessed benefits

Organizations.

Awaiting review

Depth

Organizations: 2.

Awaiting review

Reasons

Organizations: Aided clinicians reached 80.3% sensitivity and 91.4% specificity against 74.7% and 88.9% unaided.

Awaiting review

Observed or intended

Unresolved

Not reviewedUnresolved

Rubric

Unresolved

Not reviewedUnresolved

Assessor and date

Unresolved

Not reviewedUnresolved

Alternative assessments

Unresolved

Not reviewedUnresolved

Fill

Found by a regulator

Awaiting review

Entry details

Kind

The case describes an evaluation or a study. A regulatory review of a multi-reader study. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Field

Healthcare.

Awaiting review

Purpose

OsteoDetect was built to help clinicians detect distal radius fractures on wrist X-rays. Better detection is that purpose.

Awaiting review

Dates

Source published: 24 May 2018. Updated: 29 October 2026.

Awaiting review

Stage

The system was tested in a laboratory. A retrospective reader study on archived radiographs. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Version

SHA-256: 9fa13f9faf4d…

Awaiting review

SHA-256 of the public case, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.

References

Other identifiers

Unresolved

Not reviewedUnresolved

Category mappings

Unresolved

Not reviewedUnresolved

Citable summary

Unresolved

Not reviewedUnresolved

Revisions

1 revision. Latest: 29 October 2026.

Awaiting review

Sources

  1. Peer-reviewed study Developer

    Lindsey R, Daluiski A, Chopra S, et al. Deep neural network improves fracture detection by clinicians. Proceedings of the National Academy of Sciences 2018;115(45):11591-11596.

  2. Regulatory document Independent author

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for OsteoDetect (DEN180005): decision summary. Granted 2018-05-24.

Collections: Scrutiny and findings.

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Version 9fa13f9faf4d, archived in the edition of 29 October 2026

Benefit marks

Depth

The number and color show the depth of a benefit.

  1. A convenience, or time or money saved.
  2. A measurable improvement in a result or ability.
  3. A lasting change, an ability restored, or a risk removed.
  4. A serious harm averted or a serious condition resolved in time.
  5. A life or livelihood preserved, or a change documented across a population.

Beneficiary

  • Circle: a person
  • Square: an organization
  • Triangle: society

Evidence

  • Solid. A court or regulator found a benefit, or researchers independently studied it.

  • Hatched. Independent reporting.

  • Outline. Claimed by the parties. Only the people or organizations involved, or sources whose independence has not been assessed, support the benefit.

The fill changes with the evidence. The depth color stays the same.

How benefits are assessed