(188 days)
The GSA kit is for the evaluation of human semen. The kit provides the user with a set of reagents used to evaluate semen quality by measuring four (4) parameters recommended by the World Health Organization (WHO) that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include:
- . Sperm count
- Sperm motility .
- Sperm vitality t
- . White blood cell (WBC) count
The GSA kit is an in vitro diagnostic kit intended for use in a clinical laboratory test setting such as a test facility capable of providing laboratory assessment of male infertility, by skilled laboratory technicians, familiar with the handling of semen samples. This product does not contain biological materials of human origin. The kit provides the user with a set of reagents used to evaluate semen quality by measuring four parameters, recommended by the World Health Organization (WHO), that are used to help determine whether infertility is caused by abnormalities of one or more of them. The parameters to be tested for include:
- . Sperm count
- Sperm motility
- . Sperm vitality
- White blood cell (WBC) count .
The provided text describes the performance evaluation of the GSA kit for semen analysis, comparing it to the manual method recommended by the World Health Organization (WHO).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria (e.g., "Sperm Count agreement must be >90%"). Instead, the acceptance criterion for the GSA kit is generally described as being "at least as accurate as the Routine Method" and providing "more consistent results that are less dependent on the skills of an individual technician."
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (GSA Kit vs. Routine Method) |
|---|---|---|
| Sperm Count | Comparable accuracy and more precise results. | Comparable accuracy. Higher precision (Flowcytometer counts ~100x more cells). Inter- and intra-technician agreement: 91.6% in normal samples. Significantly higher reproducibility. |
| Sperm Motility | Comparable accuracy and more precise results. | Comparable accuracy. Higher precision and statistically more reproducible due to large amount of sperm cells analyzed. Inter- and intra-technician agreement: 82.3% in normal samples. Significantly higher reproducibility. |
| Sperm Vitality | Comparable accuracy and significantly more precise results. | Comparable accuracy. Significantly more precise results. Inter- and intra-technician agreement: Close agreement in normal samples. Significantly higher reproducibility. |
| WBC Count | Comparable accuracy and more precise results. | Comparable accuracy and more precise results. |
| Intra-technician Precision | Smaller typical standard deviation for each parameter than Routine Method. | Typical intra-technician standard deviation for each parameter is smaller when using the GSA kit, indicating high intra-technician precision for Flowcytometry assay. (Based on 5 semen samples repeatedly tested by the same technician). |
| Inter-technician Precision | Significantly smaller typical standard deviation for each parameter than Routine Method. | Typical inter-technician standard deviation for each parameter is significantly smaller when using the GSA kit, indicating high inter-technician precision for Flowcytometry assay. (Based on 6 semen samples tested by 3 different technicians). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For Inter- and Intra-technician experiments for Sperm Count, Motility, and Vitality: "semen samples with approximately normal sperm count." No specific number is given for these general comparisons.
- For Intra-Technician Precision: 5 semen samples were repeatedly tested.
- For Inter-Technician Precision: 6 semen samples were tested.
- Data Provenance: Blind, multi-center, prospective clinical studies.
- Country of Origin: Israel (IVF unit and outpatient clinic Lin Center, Carmel Hospital) and USA (Baylor College of Medicine, Houston Medical Center).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The ground truth (referred to as the "Routine Method") was established by "skilled laboratory technicians."
- For the inter-technician precision study, three technicians evaluated the samples using the conventional method.
- The document states that the sites "many years of experience performing semen analysis using the Routine Method," implying their expertise. Specific years of experience per technician are not detailed.
4. Adjudication Method for the Test Set:
- The document implies a comparison between two different observers/methods rather than an adjudication process for a single ground truth. "A skilled laboratory technician evaluated each semen sample by the Routine Method and by a different skilled laboratory technician using the Flowcytometry method." This suggests a direct comparison, not an adjudication of discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI assistance.
- This study compares a new device (GSA kit using Flowcytometry) against a manual method, focusing on the performance of the device and its impact on technician variability, not on AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable in the context of AI. The GSA kit uses a "Flowcytometry method," which automates parts of the semen analysis, but it's a device/kit, not an AI algorithm in the modern sense. The "standalone" performance is the performance of the GSA kit without direct human manual counting for the parameters it evaluates.
7. The Type of Ground Truth Used:
- Expert Consensus / Reference Method: The ground truth was established by the "Routine Method as recommended by the WHO," performed by skilled laboratory technicians. This serves as the reference standard against which the GSA kit's performance is compared.
8. The Sample Size for the Training Set:
- The document does not mention a training set. The GSA kit is described as a "kit" providing "reagents" and utilizing "Flowcytometry." This suggests a laboratory assay with a fixed protocol, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- As no training set is mentioned or implied for this type of device, this question is not applicable.
§ 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.”