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510(k) Data Aggregation
(253 days)
For Over-the-Counter Setting:
The LensHooke® X3 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 (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- pH value
The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility.
For Point-of-Care Professional Setting:
The LensHooke® X3 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:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive motility (%)
- Non-Progressive motility (%)
- Immotility (%)
- Sperm morphology (normal forms, %)
- pH value
The LensHooke® X3 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.
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 sperm pH, semen concentration, motility, and morphology. 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 FDA 510(k) clearance letter and summary for the LensHooke X3 PRO Semen Quality Analyzer offer a high-level overview of the device and the studies conducted. However, it does not provide explicit details on the acceptance criteria for each performance metric (e.g., specific thresholds for accuracy, sensitivity, specificity, or precision for motility, concentration, and morphology), nor does it present the reported device performance against these criteria in a quantitative manner. The summary largely discusses the types of studies performed (repeatability, reproducibility, linearity, etc.) rather than the results of those studies.
Based on the provided text, here's an attempt to structure the information, highlighting where details are not explicitly stated in the document:
Acceptance Criteria and Device Performance Study for LensHooke X3 PRO Semen Quality Analyzer
The LensHooke X3 PRO Semen Quality Analyzer was evaluated through non-clinical and user performance studies to demonstrate substantial equivalence to its predicate device, the LensHooke X1 PRO Semen Quality Analyzer. While the document mentions various types of evaluations, explicit quantitative acceptance criteria and detailed performance results are not provided for each parameter.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document states that "Verification and validation of test results were evaluated to establish the performance, functionality and reliability" and lists types of evaluations (repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, matrix comparison, sample volume, operating conditions, and stability). It also mentions a "User Performance Study." However, specific numerical acceptance criteria (e.g., minimum accuracy percentages, CVs for precision) and the achieved performance metrics are not detailed in this summary. The table below reflects the parameters measured but cannot fill in the acceptance criteria or reported performance based solely on this document.
| Parameter Measured | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Explicitly Stated in Document) |
|---|---|---|
| Sperm Concentration (M/mL) | e.g., Accuracy within X% of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
| Total Motility (PR+NP, %) | e.g., Accuracy within X% of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
| - Progressive Motility (%) | (Implicitly part of Total Motility) | Performance demonstrated as "substantially equivalent" to predicate device |
| - Non-Progressive Motility (%) | (Implicitly part of Total Motility) | Performance demonstrated as "substantially equivalent" to predicate device |
| - Immotility (%) | (Implicitly part of Total Motility) | Performance demonstrated as "substantially equivalent" to predicate device |
| Sperm Morphology (Normal forms, %) | e.g., Accuracy within X% of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
| pH Value | e.g., Accuracy within X units of reference; CV < Y% | Performance demonstrated as "substantially equivalent" to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the "System Accuracy Study" or the "User Performance study." It mentions "various test results" and "seminal samples," implying multiple samples were used.
- Data Provenance: The document does not explicitly state the country of origin for the data. The studies appear to be prospective in nature, given the description of a "user performance study... performed to demonstrate that English speaking and reading adult lay users... can easily understand and follow the labeling/user instructions to obtain accurate results."
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: For the "User Performance study," it states that "Point-of-Care professionals or licensed registered nurses" obtained POC test findings, and the LensHooke X1 PRO Semen Quality Analyzer performed by POC personnel was used as the reference method. This implies that the ground truth for this specific study was established by the predicate device and trained personnel, rather than independent human experts performing manual semen analysis (e.g., according to WHO guidelines).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth within the studies mentioned. The predicate device's output, performed by trained personnel, served as the reference for the user performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No explicit MRMC comparative effectiveness study is described where human readers improve with AI vs. without AI assistance. The study focuses on the device's performance and a "user performance study" with lay users, comparing the device's output to a reference method (the predicate device). The device itself appears to be largely automated, and the user study assessed the ability of lay users to operate the device and interpret its output, not the improvement of human readers' diagnostic accuracy with AI assistance.
6. Standalone Performance (Algorithm Only)
The document implies a standalone performance component ("Verification and validation of test results were evaluated to establish the performance, functionality and reliability... The evaluation included repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, matrix comparison, sample volume, operating conditions and stability."). These non-clinical tests would assess the device's inherent capability to measure semen parameters, which is essentially its standalone algorithm performance, as it integrates "optical design and image analysis and combined with artificial intelligence image processing method." However, the specific metrics of this standalone performance (e.g., accuracy against a gold standard manual count) are not provided.
7. Type of Ground Truth Used
- For the "System Accuracy Study" and other non-clinical tests (e.g., linearity, LoB/LoD/LoQ), the implied ground truth would be reference methods or controlled samples with known values (e.g., samples with analytically confirmed sperm concentrations or motility percentages).
- For the "User Performance study," the ground truth was derived from the predicate device (LensHooke X1 PRO Semen Quality Analyzer) results, obtained by Point-of-Care professionals or licensed registered nurses. This indicates a comparative study against an established, cleared device, rather than a direct comparison to a true biological ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not specify the sample size used for training the artificial intelligence image processing methods.
9. How Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established for the AI models used in the device. It only mentions the use of "artificial intelligence image processing method" without detailing its development or training process.
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