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The FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is a rapid test of your semen for sperm concentration. It will measure sperm as either above or below the cutoff of 20 million sperm cells per milliliter (mL). Two test results of less than 20 million cells/mL are an indicator of male infertility.

The FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility 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. The kit contains components intended for collection, preparation and testing of semen samples (pre-coated collection cups, disposable droppers, test cassettes), and the reagents to stain and wash semen samples on the test cassette. A package insert that includes a FertilMARQ Sperm Concentration Test Results form is included in the Kit. The Kit and all components are stored at room temperature.

The Kit test cassette has four wells and allows the user to perform two separate tests. For each test, there is reference color control well and an adjacent test well provided. There are two sets of reference color wells and adjacent test wells on the cassette.

Acceptance Criteria and Device Performance Study for FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility

1. Table of Acceptance Criteria and Reported Device Performance

The original document does not explicitly state pre-defined acceptance criteria for metrics like sensitivity, specificity, accuracy, and predictive values. Instead, it presents the calculated performance metrics and concludes that the device is "substantially equivalent" to the predicate and "equal to professional findings."

However, based on the presented "Calculated Contingency results," we can infer the reported performance:

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 197 semen samples were pooled from clinical studies.
• Data Provenance: The studies were conducted at "three sites." The country of origin is not explicitly stated, but the submission is to the US FDA, implying US-based studies. The studies were prospective, involving subjects producing semen samples for testing with the device.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: The ground truth was established by "professional users" or "lab technicians" at the three clinical sites. The exact number of individual experts is not specified.
• Qualifications of Experts: The experts are referred to as "professional users" or "lab technicians." Specific qualifications (e.g., years of experience, certifications) are not provided.

4. Adjudication Method for the Test Set

The adjudication method involved comparing the results from "lay users" (subjects testing at home or clinic) with those from "professional users" (lab technicians). The "professional results" were treated as the ground truth. There is no mention of a formal adjudication process like 2+1 or 3+1 among multiple professional readers; it implies a single professional assessment served as the reference.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed to assess the effect size of human readers improving with AI vs. without AI assistance. The study described compares lay user performance with professional user performance using the device, not the impact of AI assistance on human readers.

6. Standalone (Algorithm Only) Performance

The device is a "Home Diagnostic Screening Test Kit" designed for visual interpretation of a colorimetric result by the user (lay person). The "test operates by liquefaction... then filtration separation... The staining reagent... provides an average signal... This determination is made by visual interpretation." Therefore, the test inherently involves human visual interpretation, and a standalone (algorithm only) performance study is not applicable as there is no isolated algorithm component without human involvement.

7. Type of Ground Truth Used

The ground truth used was expert consensus / professional assessment. Specifically, the "professional results" obtained by lab technicians using the FertilMARQ™ Home Diagnostic Screening Test Kit itself were considered the "truth" for determining the true positive/negative status of semen samples based on sperm concentration.

• True positives: Semen samples with sperm concentrations measured by professionals above 20 million/mL.
• True negatives: Semen samples with sperm concentrations measured by professionals below 20 million/mL. (Note: The document initially lists "

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