Search Results

The FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm concentration to aid in the determination of male infertility.

The FertilMARQ™ Test Kit is an in vitro test kit for the analysis of sperm concentration. Each kit provides sufficient components to perform analysis of two separate semen samples in duplicate. The kit contains components intended to hold, treat, and test collected semen (pre-coated collection cups, disposable pipettes, test cassettes), reagents intended to stain and wash semen samples collected on the test cassette. Positive and negative control wells are incorporated into the cassette design. In addition, the package insert and a Test Results form are included in the Kit. The Kit and all components are stored at room temperature. - The test operates by physical separation of sperm from seminal plasma and other semen components after a sample is dropped onto the filter incorporated into the test cassette. The staining reagent (Thiazine Blue) reacts with multiple components present in the differentiated sperm to provide an average signal that is representative of the entire sperm population. Hundreds of thousands to millions of sperm cells are captured and vield a colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm, as compared to the negative control result, an intrinsic part of the assay.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for FertilMARQ™ Test Kit

This report details the performance of the FertilMARQ™ Test Kit, a semi-quantitative test for rapid sperm concentration analysis, and how it meets its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state acceptance criteria in a quantitative format (e.g., "Sensitivity must be >= 95%"). The reported performance metrics are presented as evidence of equivalence to the predicate device and the standard microscopic method, implying these are the benchmarks for acceptance.

2. Sample Size and Data Provenance for the Test Set

• Sample Size:
  • Clinical Evaluation: 162 semen samples
  • Dilution Study: 32 semen samples (19 samples with sperm concentration ≥ 20 million/mL, 13 samples with sperm concentration < 20 million/mL)
  • Reproducibility Studies (Site-to-site): 50 semen samples
  • Reproducibility Studies (Intra-laboratory): 102 samples
• Data Provenance: The studies were conducted at multiple sites: "a three site clinical evaluation" and "two sites" for reproducibility. The specific country of origin is not mentioned, and it is a retrospective study since the samples are being "evaluated."

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the number of experts used to establish the ground truth or their qualifications.
• The ground truth reference method is "standard manual microscopic analysis method" or "manual light microscopic method."

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The consensus appears to be based on the "standard manual microscopic analysis method" as the gold standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not conducted.
• This device is an in vitro diagnostic kit, not an AI-assisted diagnostic tool designed to augment human reader performance. The comparison is between the device's output and a standard manual laboratory method, not human interpretation.

6. Standalone Performance

• Yes, a standalone performance study was done. The reported performance metrics (Sensitivity, Specificity, Accuracy, etc.) are for the FertilMARQ™ Test Kit functioning independently (algorithm only, without human-in-the-loop performance influencing the primary determination of concentration). The kit yields a "colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm."

7. Type of Ground Truth Used

• The ground truth used was established by the standard manual microscopic analysis method for sperm concentration. This is a well-established laboratory method for semen analysis.

8. Sample Size for the Training Set

• The document does not specify the sample size for a training set. This is likely because the device is a chemical-based in vitro diagnostic kit, not a machine learning model that would typically require a distinct training set. The development of such a kit typically involves biochemical optimization and validation rather than statistical model training.

9. How the Ground Truth for the Training Set Was Established

• Since a training set (in the context of machine learning) is not explicitly mentioned or implied for this type of device, the method for establishing its ground truth is not applicable or described in the provided text. The "training" for such a device would involve the iterative development and optimization of its chemical reactions and filter design to accurately reflect sperm concentration as determined by manual microscopy.

Ask a specific question about this device