(183 days)
The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL). The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over-the-counter use.
The number of progressively motile sperm cells is only one factor that contributes to a male's fertility status. The SwimCount™ Sperm Quality Test does not provide a complete evaluation of a male's fertility status. For a comprehensive assessment of male fertility status then the patient should consult a physician.
The SwimCount™ Sperm Quality Test is intended for in vitro, over-the-counter, use and is a prescreening sperm quality test that measures the number of Progressive Motile Sperm Cells per mL (PMSCs/mL) .
The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL).
The SwimCount™ Sperm Quality Test cut-off value is derived from the WHO laboratory manual for the Examination and processing of human semen, 5th edition guidelines 2010.
The SwimCount™ Sperm Quality Test Kit includes the following components:
- SwimCount™ Sperm Quality Test Box ●
- SwimCount™ Sperm Quality Test Device ●
- Semen Collection Cup (used to collect the sperm sample is to remain in the sample cup for 30 minutes)
- . Semen Transfer Pipette (syringe) (used to stir the semen sample 10 times before adding the sample to the Device and further used to collect 0.5 mL semen sample from the sperm sample placed in the cup)
- SwimCount™ Sperm Quality Test Instructions for Use .
The acceptance criteria and study proving the device meets those criteria are detailed below, primarily extracted from the "Summary - SwimCount™ Sperm Quality Test" section of the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate section with specific numerical targets. However, the performance outcomes of key studies (Multi-Center Clinical Study and Lay-User Usability/Interpretation Studies) serve as the implicitly accepted performance metrics for substantial equivalence. The primary clinical performance metrics are Sensitivity, Specificity, and Accuracy against the manual sperm count reference. For usability, the emphasis is on the percentage of correct interpretations by lay-users.
Here's a table summarizing the reported device performance, effectively serving as the demonstrated acceptance criteria through the provided study results:
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance | Study Context |
|---|---|---|
| Sensitivity (Clinical) | 95.83% (95% CI: 88.30%-99.13%) | Multi-Center Clinical Study |
| Specificity (Clinical) | 90.68% (95% CI: 86.23%-94.07%) | Multi-Center Clinical Study |
| Accuracy (Clinical) | 91.88% (95% CI: 89.90%-95.81%) | Multi-Center Clinical Study |
| Lay-User Correct Calls (Usability - Performance) | 97.53% | Lay-User Usability Study (performance of test completion) |
| Lay-User Correct Calls (Usability - Interpretation) | 97.65% (95% CI: 96.70%-98.81%) | Consumer Interpretation Study (picture interpretation) |
| Repeatability (% correct) | 98.8% Overall (75-100% per concentration) | Repeatability Study |
| Reproducibility (% correct) | 100% at 30 min & 60 min after collection at all tested concentrations | Reproducibility Study |
2. Sample Size Used for the Test Set and Data Provenance
- Multi-Center Clinical Study (Test Set):
- Sample Size: 308 net semen samples across four centers. A total of 323 samples were initially collected, but 15 were excluded for analysis due to various reasons (e.g.,
§ 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.”