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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 changes in menopause. This kit provides a preliminary screening result. This kit is intended for over-the-counter sales.

Immunoassay for the qualitative detection of FSH in urine.

Here's an analysis of the provided information regarding the Moments Menopause Check (Model 9113), focusing on its acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Moments Menopause Check (Model 9113)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the sample size used for the clinical sample correlation study or the blind labeled spiked study.
• Data Provenance: The studies used "clinical specimens." The country of origin for the data is not specified, but the manufacturer is Phamatech, located in San Diego, California, USA. The studies appear to be prospective, as they were conducted to evaluate the performance of the Moments Menopause Check.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the performance studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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 how much human readers improve with AI vs. without AI assistance. This device is a rapid, qualitative immunoassay for over-the-counter use, and such a study design is generally not applicable to this type of diagnostic.

6. Standalone Performance Study

A standalone performance study was performed. The "clinical sample correlation study" and "blind labeled spiked study" evaluated the device's performance (qualitative detection of FSH in urine) independently. The "consumer study" also assessed the device in a standalone context, focusing on user interpretation.

7. Type of Ground Truth Used

• Clinical Sample Correlation Study: The ground truth for this study was likely established by the "predicate devices" to which the Moments Menopause Check was compared. This implies a comparison to existing, legally marketed FSH tests which themselves have established accuracy.
• Blind Labeled Spiked Study: For this study, the ground truth would have been based on known, controlled concentrations of FSH that were "spiked" into samples, allowing for a direct assessment of the device's ability to detect FSH at the specified threshold (25 mIU/ml).
• Consumer Study: The ground truth for the consumer interpretation was likely derived from the objective results of the FSH test (e.g., whether FSH was actually present at the detectable level) and then compared to the consumer's visual interpretation.

8. Sample Size for the Training Set

The document does not provide information about a training set since this is a chemical test (immunoassay) and not a machine learning or AI-based device. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here. The device's performance is based on its inherent chemical properties and design.

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

As mentioned above, the concept of a training set and its ground truth is not applicable to this device, which relies on immunoassay technology rather than machine learning.

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