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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 "< 5 million/mL" then corrects it to "< 20 million/mL").

8. Sample Size for the Training Set

The document states, "The design and performance of the kit are essentially the same as the predicate device. Therefore no additional kit performance studies were performed." This implies that the current submission primarily relies on performance data from the predicate device and the clinical study described. There is no explicit mention of a separate training set or its sample size for the current device, as the study presented is a validation study demonstrating substantial equivalence for the subject device.

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

As noted above, there is no explicit mention of a new training set for this device in the provided text. The device is claimed to be "essentially the same as the predicate device." Therefore, any "training" (development and optimization) would have likely occurred for the predicate device, or implicitly the design of the subject device leverages the established performance of the predicate. How ground truth was established for that process (if any) is not detailed in this submission.

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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.

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