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The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.

Immunoassay for the qualitative detection FSH (follicle stimulating hormone) in urine. The Moments Menopause Check, like many commercially available FSH screening test kits, qualitatively measures the presence of FSH by visual color sandwich one step immunoassay technology.

Here's a summary of the acceptance criteria and study details for the Moments Menopause Check device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample sizes for the clinical sample correlation study and the consumer study are not explicitly stated in the provided text.

• Data Provenance: The text indicates "Laboratory studies, using clinical specimens" and "A consumer study was also performed." This implies that the data was collected from human participants, likely in a prospective manner for the consumer study, and potentially retrospective or prospective for the clinical sample correlation study, though this is not specified. The country of origin is not mentioned, but the manufacturer is based in San Diego, California, USA, suggesting the studies likely originated there.

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

• Clinical Sample Correlation Study: The "predicate devices" were used as the comparison for establishing ground truth. The expertise involved in generating results from the predicate devices is not specified, but it's implied that these are established, commercially available tests.
• Consumer Study: The ground truth for the consumer study's accuracy (97%) is not explicitly described in terms of "experts." It refers to the device's accuracy in the hands of lay users, suggesting the "truth" against which their results were compared was likely derived from the established laboratory methods (predicate devices) on the same samples, although this is inferred.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated in the provided text for either study.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focus on comparing the device to predicate devices and assessing accuracy with lay users, not on how human readers' performance improves with or without AI assistance. The device itself is a qualitative immunoassay, not an AI-assisted diagnostic.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance was done. The "clinical sample correlation study" and the "consumer study" directly assess the performance of the Moments Menopause Check device itself (the "algorithm" in this context refers to the device's inherent detection mechanism) without explicit human-in-the-loop assistance influencing the detection mechanism itself, beyond the user performing the test.

7. Type of Ground Truth Used

• Clinical Sample Correlation Study: The ground truth was established by comparison to predicate devices. This implies the results from established, commercially available FSH screening test kits were considered the "truth."
• Consumer Study: The ground truth for the accuracy assessment against the lay user's results was likely established by laboratory methods (predicate devices) on the same samples, though this is not explicitly stated.

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This type of immunoassay device typically does not involve a "training set" in the machine learning sense. Performance is established through validation studies.

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

As no training set is mentioned for this type of device, this question is not applicable.

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