(270 days)
The LensHooke X12 PRO Semen Analysis System used with LensHooke Semen Test Slide is an optical device for human semen analysis which provides direct and calculated measurements for:
(1) Sperm concentration (M/mL)
(2) Total motility (PR+NP, %)
• Progressive Motility (PR, %)
(3) Sperm Morphology (normal forms, %)
The LensHooke X12 PRO Semen Analysis System used with LensHooke R10 Plus Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) and LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR Assay) is an optical device for human semen analysis which provides direct measurement for:
(1) Sperm DNA Fragmentation Index (DFI, %)
The LensHooke X12 PRO Semen Analysis System 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 clinical laboratories to evaluate male fertility.
The i.MX 6ULL is a high performance, feature-rich and low-power processor.
The provided 510(k) summary for the LensHooke X12 PRO Semen Analysis System offers a high-level overview of the device and its claimed substantial equivalence to a predicate device. However, it lacks the detailed information typically required to fully describe the acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document states: "Verification and validation of test results were evaluated to establish the performance, functionality and reliability of LensHooke X12 PRO Semen Analysis System. The evaluation included repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, sample volume, operating conditions, stability and matrix study." and "System Accuracy Study and User Performance study". These are general categories of tests, but the specific acceptance criteria and the results proving they were met are not explicitly provided.
Therefore, many parts of your request cannot be fully answered with the given text. I will fill in what can be inferred or is explicitly stated, and clearly mark what information is missing.
Device: LensHooke X12 PRO Semen Analysis System
The LensHooke X12 PRO Semen Analysis System is an optical device for human semen analysis that provides direct and calculated measurements for:
- Sperm concentration (M/mL)
- Total motility (PR+NP, %)
- Progressive Motility (PR, %)
- Sperm Morphology (normal forms, %)
- Sperm DNA Fragmentation Index (DFI, %) (when used with specific test kits)
1. Table of Acceptance Criteria and Reported Device Performance
MISSING INFORMATION: The 510(k) summary does not provide a specific table of acceptance criteria or the numerical results for each performance metric (e.g., specific accuracy thresholds, precision ranges). It states that "results of performance evaluation... demonstrate that the subject devices are substantial equivalence to the predicate device," implying that the performance met acceptable levels, but the actual targets and outcomes are not detailed.
To illustrate what would be in such a table if the information were available in the provided text:
| Performance Metric | Acceptance Criteria (Example) | Reported Device Performance (Example based on typical expectations for such devices, not found in text) |
|---|---|---|
| Sperm Concentration | % bias within +/- X% of reference; R² > 0.Y vs. reference | (e.g., Bias 90%; Bias 85%; Bias 80% for normal forms) |
| DNA Fragmentation Index | % bias within +/- D% of reference | (e.g., Bias 0.YY across specified range |
| Interference | No significant interference from common substances | (e.g., Bilirubin, Triglycerides, Hemolysate at specified levels) |
| Stability | Device/reagents stable under specified conditions | (e.g., Stable for X months/hours) |
| Usability (User Perf. Study) | User accuracy/ease of use met pre-defined criteria | (e.g., High scores on participant questionnaire) |
Note: The metrics like repeatability, reproducibility, LoB/LoD/LoQ, linearity, interference, sample volume, operating conditions, stability, and matrix study are mentioned as having been evaluated, which would typically have associated acceptance criteria and reported performances, but these are not disclosed in the provided FDA letter.
2. Sample Size Used for the Test Set and Data Provenance
MISSING INFORMATION: The document states that a "System Accuracy Study" and "User Performance study" were performed for the non-clinical tests. However, the specific sample sizes (e.g., number of semen samples, number of users) used in these studies are not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It only states the submitter is from Taichung, Taiwan, which might imply the studies were conducted there.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
MISSING INFORMATION: The 510(k) summary does not specify the number of experts used to establish ground truth for the test set. It also does not specify the qualifications of these experts.
For the user performance study, it mentions "professional/English reading users, across educational backgrounds" but this refers to the users of the device being tested, not necessarily the experts establishing ground truth for the "System Accuracy Study."
4. Adjudication Method for the Test Set
MISSING INFORMATION: The document does not describe any adjudication method (e.g., 2+1, 3+1 consensus) used for establishing ground truth for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
MISSING INFORMATION: The 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is described as an "automated" and "optical device for human semen analysis," which implies a primary focus on automated measurement rather than AI assistance for human image interpretation in the same way an AI for radiology might function.
The "User Performance study" was described as demonstrating that "professional/English reading users... can easily understand and follow the labeling/user instructions to obtain accurate results while using Subject Device." This is a usability and user accuracy study, not an MRMC study comparing AI-assisted vs. unassisted human performance.
6. Standalone (Algorithm Only) Performance
Partially Addressed/Inferred: The device is described as an "optical device for human semen analysis which provides direct and calculated measurements" using "image analysis and combined with artificial intelligence image processing method." This implies that the device operates as a standalone algorithm to perform the semen analysis.
The "System Accuracy Study" would have been conducted to evaluate this standalone performance against a ground truth method (the predicate device "X1 RPO performed by lab personnel was used as a reference method" for the user performance study, and presumably for the system accuracy study as well, though it's not explicitly stated for the latter).
7. Type of Ground Truth Used
Inferred/Partially Addressed:
- For the "System Accuracy Study" and "User Performance Study," the predicate device, "X1 RPO performed by lab personnel was used as a reference method." The X1 RPO is also an automated semen analysis system. This means the ground truth was based on the measurements obtained from the predicate device (another automated system), presumably validated for accuracy.
- It is common in such evaluations that the predicate device's results are considered the "reference" or "ground truth" for comparison. However, true "ground truth" for semen analysis often involves manual microscopy by trained and experienced laboratory personnel following World Health Organization (WHO) guidelines, which is considered the gold standard for manual methods. The document does not explicitly state if the predicate device's performance itself was validated against such a manual gold standard, or if "lab personnel" performing X1 RPO analysis implies any manual verification for the study.
8. Sample Size for the Training Set
MISSING INFORMATION: The 510(k) summary does not provide any information about the sample size used for the training set for the AI/image processing algorithms.
9. How the Ground Truth for the Training Set Was Established
MISSING INFORMATION: The 510(k) summary does not provide any information on how the ground truth for the training set was established. Given the device uses "artificial intelligence image processing method," training data with established ground truth would be essential, but details are not disclosed in this summary.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”