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The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. It also provides a qualitative assessment of semen volume.

Sperm concentration and semen volume are only two factors that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use.

The revised Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Props), and consumables, including Volume Cups and sample droppers.

The Volume Cups are used collect, liquefy, and assess the volume of the semen sample. Markings on the Volume Cup allow the interpretation of volume at/below or above the 1.5 mL threshold. The Trak Engine and Props allow for the semi-quantitative assessments of total sperm concentration: below 15 million/mL, between 15 and 55 million/mL, and above 55 million/mL.

Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or "pellet"). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium.

During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on "top" of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended "above" the medium, substantially separated from the sperm cells and are generally too diffuse to visualize.

This document describes the Trak® Male Fertility Testing System and the studies conducted to establish its performance, particularly focusing on the volume measurement component.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Semen Volume Assessment (Stage 1 Study: Interpretation of Photographs):
  • Sample Size: 232 semen sample photographs.
  • Data Provenance: Retrospective (photographs of samples with pre-established reference volumes). The country of origin is not explicitly stated.
• Semen Volume Assessment (Stage 2 Study: Interpretation of Simulated Sample in the Volume Cup):
  • Sample Size: 127 artificial semen samples (Cups filled with 1 mL, 1.2 mL, or 2 mL).
  • Data Provenance: Prospective (simulated samples prepared for the study). The country of origin is not explicitly stated.
• Precision of Volume Cup: 75 total replicates for each of 5 artificial semen samples (3 lots, 3 operators, 5 days, 5 replicates each).
• Functional Equivalence (Semen Liquefaction): 20 semen sample aliquots from three semen samples.
• Functional Equivalence (Trak Sperm Concentration Category Result Equivalence Study): 2 semen pools (10 M/mL and 20 M/mL), tested in 20 replicates for each cup type.
• Functional Equivalence (Semen Homogenization Study): Two semen samples formulated to two sperm concentrations differing by more than 50%. 20 aliquots taken from the top and bottom of each cup for each pool.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Semen Volume Assessment (Stage 1 & 2): The ground truth was established by a "reference method" (calibrated scale for volume measurement). No specific number or qualifications of human experts for ground truth establishment are provided for these studies. For Stage 1, "trained technicians" also interpreted the photographs, effectively serving as an expert comparison to the lay subjects. Their qualifications are not explicitly detailed beyond being "trained."
• Sperm Concentration Category Result Equivalence Study: The ground truth for sperm concentration was established using Computer Assisted Semen Analysis (CASA). The qualifications of CASA operators or the number of such experts are not specified.

4. Adjudication Method for the Test Set

• The document primarily describes studies comparing device performance (Lay Subject or Trained Technician interpretation) against a "reference method" (calibrated scale for volume, CASA for concentration). This implies an objective ground truth, rather than an adjudication process between human readers.
• For the "Trained Technician vs Lay Subject" comparison in Stage 1, there's a direct comparison, but not an adjudication to establish a single truth; rather, it assesses agreement between these groups.

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 MRMC comparative effectiveness study involving AI assistance for human readers is described. This device is an over-the-counter home-use system designed for direct user interpretation, not an AI-assisted diagnostic tool for expert human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• The Trak® Male Fertility Testing System is a device with a visual readout interpreted by the user (human-in-the-loop). There is no description of a standalone algorithm performance without human interpretation. The "Engine" spins the sample, and the "Prop" creates a visible column, but the user "interprets" the column height for concentration and fluid height for volume.

7. The Type of Ground Truth Used

• Semen Volume Assessment: The ground truth was established by a "calibrated scale" for direct volume measurement. This is an objective measurement.
• Sperm Concentration Category Result Equivalence Study: The ground truth was established using Computer Assisted Semen Analysis (CASA). This is an objective, automated method.
• Functional Equivalence Studies (Liquefaction, Homogenization): Ground truth was established by quantitative volume measurements and sperm concentration assessments (presumably by CASA or similar lab methods).

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of an algorithm or AI. The studies described are validation studies for the device's performance when used by humans. The device itself (Trak Engine and Props) is pre-calibrated and designed, so there isn't a traditional "training set" as understood in machine learning. However, the development and internal testing of the device would have involved samples, but these are not articulated as a distinct "training set" in this context.

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

• Since a formal "training set" for an algorithm is not described, the method for establishing its ground truth is not applicable in this document. The ground truth for the validation studies, as detailed in point 7, was established by objective reference methods like calibrated scales and CASA.

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