LensHooke X1 let lay users measure sperm concentration accurately

In FDA's review of the LensHooke X1, 100 lay users tested semen with the AI analyzer. Their sperm concentration results tracked a reference analyzer with a slope of 0.98 and an R2 of 0.98.

  • Not rated a person

    Lay users' results matched a reference analyzer in a study at evaluation sites, and no use at home is reported.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

A point-of-care professional testing the same samples on the SQA-V reference analyzer. Measured.

The system’s part
Not isolated. The study compared lay users' results on the device with a professional's results on the SQA-V reference analyzer. It did not compare analysis with and without the image processing. FDA calls the method an artificial intelligence image processing method but does not say whether it learned from data.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Accessibility
System
LensHooke X1 and X1 PRO Semen Quality Analyzer
Made by
Bonraybio Co., Ltd.
Used by
Bonraybio (user performance study with 100 lay users at three evaluation sites)
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Estimating the Quantifiable Characteristics of Products, Events, or Information, Identifying Objects, Actions, and Events
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary for LensHooke X1 PRO and X1 Semen Quality Analyzer (K180343). Cleared 2018-11-16. Section X.A.4, Accuracy (Instrument), Method Comparison, pp. 9-10.

    A user performance study was conducted to determine test performance of the LensHooke X1 Semen Quality Analyzer when used by unassisted lay users following the instructions in the package insert.

Details

AI system

Workflow

Lay users followed only the instructions in the package insert. Samples were collected in the kit's cup and left to liquefy for at least 30 minutes before testing.

Follow-up

Conditions for replication

The test is run within one hour of collecting the sample. The home device is used by one person and is not shared.

Entry details

Sector

Healthcare.

Purpose

Bonraybio built the LensHooke X1 Semen Quality Analyzer so that people can measure sperm concentration, motility and morphology and semen pH at home to evaluate male fertility.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). LensHooke X1 let lay users measure sperm concentration accurately (AIBD-0861). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0861.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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