(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 |
§ 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.”