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The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for home use.
The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for over-the-counter (OTC) home use.

The Fertell Male Fertility Test measures the concentration of progressively motile sperm in a fresh semen sample. The test is performed between two and seven days after the last ejountion.

Semen is collected directly into a custom design collection container and allowed to liquefy for 30 minutes. A test unit is then positioned onto the liquefied sample and the pressing of a button releases a solution of sodium hyaluronate buffer solution over the semen sample and stats heating the fluid to 37℃. Motile sperm swim-up through the sodium hyaluronate for 30 minutes before a valve is opened, by turning a knob, allowing the buffer solution, and motive 50 mm present, to flow along a capillary channel. Anti-CD59 monoclonal antibody that is conjugated with colloidal gold is released from an absorbent pad in the channel and reacts with the sperm forming an immunocomplex of gold-labeled sperm. The fluid containing this complex flows onto a nitrocellulose strip where the gold-labeled sperm are trapped, forming a realine. Unreacted conjugate is washed from the strip by the flow of excess buffer.

Turning the knob back to its original position closes the valve and reveals the test result. The appearance of a clear red line (test result) indicates motile sperm in the semen sample at a concentration of≥10M/mL. This level is indicative of normally expected motile sperm concentrations.

The device has a microprocessor to control internal fluid temperature at 37° C and provide user prompts by an LED that changes state at the end of each timed activity. A control line is present on the nitrocellulose test strip to confirm to the user that the test has functioned correctly.

Here's a breakdown of the acceptance criteria and study information for the Fertell Male Fertility Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because specific percentage thresholds for acceptance are not explicitly stated in the provided text. However, the reported performance levels (e.g., 94.8%, 95.0%, 95.7%) are presented as demonstrative of successful validation.

2. Sample Sizes and Data Provenance

• Lay User Performance (Consumer Field Evaluation):
  • Test Set Sample Size: 433 subjects.
  • Data Provenance: Not explicitly stated, but "consumer field evaluation" suggests data collected from actual consumers in their home environment. The mention of "three sites" indicates multiple collection points. It is prospective as it involves subjects performing the test according to instructions.
• Lay Users vs. Professionals Study:
  • Test Set Sample Size: 121 subjects.
  • Data Provenance: Not explicitly stated, but trials were conducted at a "trial site" where lay users provided semen samples. This suggests controlled, prospective data collection.
• Method Comparison Study (Device vs. Predicate):
  • Test Set Sample Size: 140 subjects.
  • Data Provenance: Not explicitly stated, but "trial site" suggests controlled, prospective data collection.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Lay User Performance (Consumer Field Evaluation): No experts were used to establish ground truth for this study. The ground truth was based on the subjects' responses to a questionnaire about their experience and understanding of the instructions.
• Lay Users vs. Professionals Study:
  • Number of Experts: Not explicitly stated, but the study involved "a professional" who independently read the test result. It is implied there was at least one professional per test.
  • Qualifications of Experts: Not specified beyond being referred to as "a professional." It can be inferred that they were trained and experienced in interpreting semen analysis results from such tests.
• Method Comparison Study (Device vs. Predicate):
  • Number of Experts: Not explicitly stated, but "a laboratory professional" performed testing using the predicate methods and the Fertell Test. It is implied there was at least one professional per test.
  • Qualifications of Experts: Not specified beyond being a "laboratory professional." It can be inferred that they were trained and experienced in performing and interpreting laboratory-based semen analysis, including CASA and modified Kremer tests.

4. Adjudication Method for the Test Set

• Lay User Performance (Consumer Field Evaluation): No adjudication method was mentioned for this study, as it focused on questionnaire responses and successful task completion directly by the lay user.
• Lay Users vs. Professionals Study: The method involved independent interpretation by "the lay user and a professional... without either having knowledge of the other's result." This suggests a non-adjudicated comparison where the professional's reading likely served as the gold standard against which the lay user's reading was compared.
• Method Comparison Study (Device vs. Predicate): The specific adjudication method is not described. It states that "testing of the sample by the two predicate methods and by the Fertility Test was performed by a laboratory professional." This suggests the comparison was made between the device's output and the outputs of the predicate methods, likely with the predicate methods serving as the reference standard.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or clearly described. The "Lay Users vs. Professionals study" involved comparing readings, but it focused on the equivalence of reading results between two types of readers (lay vs. professional) rather than measuring the improvement of human readers with AI assistance versus without. The device itself (Fertell Male Fertility Test) is designed as a standalone
  test to be read by the user, not an AI or software offering assistance to human readers.

6. Standalone Performance Study

• Yes, a standalone performance study was implicitly done. The "Method Comparison Study" evaluated the Fertell Male Fertility Test's performance against established laboratory predicate methods. This measures the device's ability to accurately measure motile sperm concentration independently of a human reader's interpretive assistance, beyond the basic visual interpretation of the result line. The professional performing the test for this study is operating the device and the predicate, not acting as an "assisted reader." Therefore, this study demonstrates the standalone performance of the device against a gold standard.

7. Type of Ground Truth Used

• Lay User Performance (Consumer Field Evaluation): The ground truth concerned the correct completion of steps and understanding of instructions, as indicated by questionnaire responses.
• Lay Users vs. Professionals Study: The ground truth for interpreting the test result was established by the professional's independent reading of the Fertell Male Fertility Test.
• Method Comparison Study (Device vs. Predicate): The ground truth for motile sperm concentration was established by predicate laboratory methods:
  • Computer-aided sperm analysis (CASA) using the Hamilton Thorne IVOS system.
  • A modified Kremer test (sperm migration test).

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. The descriptions focus on the validation (test) sets for clinical and method comparison studies. For medical devices like this, development typically involves internal testing and iterative refinement during the R&D phase, but a formally documented "training set" in the context of machine learning (AI) is not mentioned because the device is not described as a deep learning model requiring such a set. It's a diagnostic test with specific chemical and physical reactions.

9. How Ground Truth for the Training Set Was Established

• As no separate training set is explicitly mentioned or described as part of a formal validation, the method for establishing its ground truth is not provided. The device's operation is based on biochemical principles and physical processes rather than learning from data, so the concept of a "training set" in the AI sense wouldn't apply directly.

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