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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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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. Sperm concentration is only one factor 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 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 collection cups and sample droppers. 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.

Acceptance Criteria and Device Performance for Trak® Male Fertility Testing System

The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at three distinct levels: ≤ 15 M/mL, between 15 and 55 M/mL, and > 55 M/mL. The device must demonstrate sufficient accuracy and user interpretability for its intended over-the-counter home use.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria are based on the conditional probability of a correct Trak result when compared to a Computer Aided Semen Analysis (CASA) reference method.

Additional Acceptance Criteria (Demonstrated in Non-Clinical Studies):

• Near-Cutoff Validation: Trak generates results adequately close to the 15 M/mL and 55 M/mL thresholds.
• Precision: The Trak system demonstrates adequate measurement precision for consistent semi-quantitative results.
• Consumer Interpretation: Lay users are able to correctly interpret Trak results, particularly near the 55 M/mL threshold (Overall Percent Agreement (OPA) of 97.4%).
• Interference Testing: Substances like saliva, urine, most microorganisms (E. coli, C. albicans, C. trachomatis, N. perflava), and hormones (testosterone, D-norgestrel, B-estradiol) do not interfere with Trak results at relevant concentrations. Note: 3 M/mL leukocytes and 1% whole blood failed acceptance criteria, requiring labeling limitations.
• QC Material Precision: QC material formulations meet acceptance criteria with 100% correct calls.
• Cleaning Robustness: The Trak Engine maintains performance after repeated cleaning and disinfection cycles.
• Prop Stability: Trak Props demonstrate real-time stability beyond the claimed expiry date.
• QC Material Stability: QC material demonstrates stability beyond the claimed expiry date.

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

• Sample Size for Clinical Study (Test Set): 239 male subjects provided semen specimens for analysis.
• Data Provenance: The clinical study was a cross-sectional, multi-site investigation conducted at three clinical sites in the United States. Subjects were either presumptively healthy, a partner in a couple having difficulty conceiving, diagnosed with male factor infertility, post-vasectomy patients, or post-vasectomy reversal patients. This suggests a prospective study design.

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

• The document implies that one "HCP technician" per site analyzed an aliquot of the original semen specimen on a Computer Aided Semen Analysis (CASA) system to establish the ground truth.
• Qualifications: "HCP technician employed at the site". Specific qualifications (e.g., years of experience, specific certifications) are not detailed beyond "HCP technician."

4. Adjudication Method for the Test Set

• For the clinical study, the process involved:
  1. Subject/Tester analyzes semen with Trak and records result.
  2. Health-Care Professional (HCP) observes the Prop and records their own interpretation of the subject/tester's result.
  3. HCP performs their own Trak test using a saved aliquot and records the result.
  4. HCP technician analyzes an additional aliquot on a CASA system (ground truth).
• The primary comparison for the performance parameters (conditional probability) is between the Subject/Tester Trak results and the CASA reference method. The document does not explicitly state an adjudication method (like 2+1, 3+1) for resolving discrepancies between multiple expert interpretations of the CASA results or between the subject's Trak interpretation and the HCP's interpretation of the subject's Trak result. The CASA system is presented as the definitive ground truth. The HCP's interpretation of the subject's Trak result and their own Trak test seem to be for internal validation or comparison rather than a formal adjudication of the ground truth.

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 explicitly described or performed.
• However, the Consumer Interpretation Study can be viewed as a form of reader study, assessing lay users' ability to interpret results. In this study, 61 lay subjects (readers) interpreted images of 7 Trak Props (cases). The "correct interpretation" served as the reference. The Overall Percent Agreement (OPA) was 97.4%. This study only involved interpretation of the device's output by lay users, not an "AI assistance" scenario for human readers evaluating a separate output.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• This device is not an AI algorithm. It is a physical diagnostic device that produces a visual output (a column of sperm cells) that is interpreted by the user. Therefore, a "standalone algorithm only" performance study is not applicable in the traditional sense of AI.
• The analytical sensitivity and precision studies, where Trak results were compared to CASA measurements, represent the closest equivalent to a "standalone" or objective performance evaluation of the device itself, independent of user interpretation (beyond the initial reading by lab personnel). These studies measured the device's output (column height, categorized into concentration ranges) rather than a human's interpretation of that output.

7. Type of Ground Truth Used

• For the clinical study (test set): Computer Aided Semen Analysis (CASA) results in M/mL were used as the reference method and ground truth.
• For non-clinical studies (e.g., analytical sensitivity, precision, interference): CASA results were also used as the ground truth. For some studies, "reference values" or "expected category" based on formulations were used, which were confirmed by CASA.

8. Sample Size for the Training Set

• The document describes premarket notification (510(k)) studies for a medical device that does not involve artificial intelligence or machine learning. Therefore, there is no specific "training set" in the conventional sense of machine learning. The device's operational principles (density gradient separation, centrifugal action) are based on established scientific principles rather than being "trained" on a dataset.

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

• As there is no "training set" for an AI/ML algorithm, this question is not applicable. The device's design and parameters would have been developed and refined through engineering and analytical studies, likely using samples with known characteristics, but not in the format of an AI training set with ground truth labels.

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