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The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

(1) Sperm concentration (10^6 per ml)

(2) Total motility (PR+NP, %)

• Progressive motility (%)

• Non-Progressive motility (%)

(3) Sperm morphology (normal forms, %)

(4) pH value

The LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.

The LensHooke X1 PRO SE Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for:

-Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value

The LensHooke X1 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a seff-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared.

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

The provided text describes the 510(k) summary for the LensHooke X1 PRO Semen Quality Analyzer and LensHooke X1 PRO SE Semen Quality Analyzer. Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. It states that "Verification and validation of test results were evaluated to establish the performance, functionality and reliability of LensHooke X1 PRO SE Semen Quality Analyzer and LensHooke X1 PRO Semen Quality Analyzer. The evaluation included Repeatability, Reproducibility, LoB/LoD/LoQ and linearity, sample volume, operating conditions and stability." However, specific numerical targets for acceptance criteria and the corresponding device performance results are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample size used for the system accuracy study. It mentions a "user performance study" which involved English-speaking and reading lay users across educational backgrounds, and also Point-of-Care professionals or licensed registered nurses. However, the number of participants for these studies is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the studies were retrospective or prospective, though "user performance study" typically implies a prospective design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document indicates that for the "System Accuracy Study and Layuser Performance study," the "SQA-V Analyzer performed by POC personnel was used as a reference method." This implies that the ground truth was established by the SQA-V Analyzer, and its performance was managed by Point-of-Care (POC) personnel. The text does not specify the number of individual experts or their detailed qualifications (e.g., "radiologist with 10 years of experience") beyond "Point-of-Care professionals or licensed registered nurses."

4. Adjudication Method

The document does not mention an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It states that the SQA-V Analyzer was used as the reference method, implying a direct comparison rather than a consensus-based adjudication process among multiple human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study focuses on the device's accuracy against a reference method and lay user performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "System Accuracy Study" implicitly describes the algorithm's performance (as part of the LensHooke X1 PRO/PRO SE Analyzer) against a reference method (SQA-V Analyzer). The device is an "optical device... which provides direct and calculated quantitative measurements," meaning it operates autonomously to produce these measurements. The "Layuser Performance study" also evaluates the standalone device's accuracy when used by laypersons.

7. Type of Ground Truth Used

The ground truth for the system accuracy study was established using a "SQA-V Analyzer performed by POC personnel" as a reference method. This suggests a comparative reference method or known standard approach, rather than solely expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the AI image processing algorithm.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established. It only mentions that the device uses "artificial intelligence image processing method" for analysis.

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