Paige Prostate helped pathologists catch cancer missed on a first read

In the reader study that FDA reviewed for Paige Prostate, assisted reads improved sensitivity in 7.3% of prostate biopsy images with cancer, and specificity rose 1.1 points.

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

Benefit

Improvement in sensitivity in 7.3% of biopsy images

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

Paige Prostate

Awaiting review

Model

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

Not reviewedUnresolved

Reported configuration

2.1.501

Awaiting review

Provider

Unresolved

Not reviewedUnresolved

Role

Unresolved

Not reviewedUnresolved

Configuration

Unresolved

Not reviewedUnresolved

Inputs and outputs

Unresolved

Not reviewedUnresolved

Autonomy

Unresolved

Not reviewedUnresolved

Workflow

Slides were scanned on a Philips Ultra Fast Scanner and viewed in FullFocus. Pathologists made an unassisted read before seeing the software result.

Awaiting review

Human oversight

Unresolved

Not reviewedUnresolved

Relation to AI

Each pathologist read every image unassisted and then assisted, so the change in calls is attributed to the software result.

Awaiting review

AI contribution

Each pathologist read every image unassisted and then assisted, so the change in calls is attributed to the software result.

Awaiting review

Measurement

Studies

Quasi-experimental. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Study design

Quasi-experimental. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Measurement

Sequential unassisted then assisted reads of whole slide images against diagnostic report ground truth. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Setting and sample

Sixteen pathologists; 610 whole slide images originally, 171 cancer slides analyzed for the sensitivity change. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Measures

Per-slide sensitivity and specificity. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Comparison

Unassisted read by the same pathologist. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Results

Sensitivity improved in 7.3% of cancer slides; specificity 88.45% to 89.50%. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Additional value from AI

7.3% net sensitivity gain per biopsy image. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Limitations

Measured per biopsy image; the per-patient gain is likely lower; retrospective images. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Denominators

One assisted read per image. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Materials for replication

None public. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

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: Paige.AI, Inc. Operator: Paige.AI (pivotal reader study with sixteen pathologists).

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 software is used after the pathologist's own review. Slides come from H&E stained prostate needle biopsies.

Awaiting review

Replication attempts

Unresolved

Not reviewedUnresolved

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-0624-source-0001

Awaiting review

Citations

Numbered references below.

Awaiting review

Language

Unresolved

Not reviewedUnresolved

Source relationships

Independent

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. The cited evidence includes no independent study or report. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Missing evidence

Unresolved

Not reviewedUnresolved

Grades

Assessed benefits

Organizations.

Awaiting review

Depth

Organizations: 2.

Awaiting review

Reasons

Organizations: Assisted reads improved sensitivity in 7.3% of biopsy images with cancer, and specificity rose from 88.45% to 89.50%.

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 reader study. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Field

Healthcare.

Awaiting review

Purpose

Paige Prostate was built to help pathologists detect foci suspicious for cancer in prostate biopsy images. Better detection is that purpose.

Awaiting review

Dates

Source published: 21 September 2021. Updated: 29 October 2026.

Awaiting review

Stage

The system was tested in a laboratory. A reader study on previously diagnosed slide images before authorization. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Version

SHA-256: a0a94f75e4a2…

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. Regulatory document Independent author

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Paige Prostate (DEN200080): decision summary. Granted 2021-09-21.

Collections: Scrutiny and findings.

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Version a0a94f75e4a2, 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