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FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.

One Step FSH Menopausal Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the "One Step FSH Menopausal Test":

A. Acceptance Criteria and Reported Device Performance

The acceptance criteria for diagnostic tests often involve measures like sensitivity, specificity, and accuracy, especially when comparing to a reference method or clinical endpoint. While the specific numerical acceptance criteria established by the manufacturer are not explicitly detailed in this FDA letter (which typically focuses on substantial equivalence), the provided data implies a performance standard for "positive agreement" and "negative agreement" in comparison to a predicate device or clinical reference.

Note: The FDA 510(k) summary usually provides the specific acceptance criteria. This document indicates the device is "substantially equivalent," meaning its performance is comparable to a legally marketed predicate device, implicitly meeting accepted performance standards for its intended use.

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

The provided document does not explicitly state the specific sample size used for the test set in a clinical study to validate these performance metrics. The agreement percentages (Positive Agreement, Negative Agreement, Overall Agreement) are listed, but the accompanying sample sizes for "Professional Use" and "Lay Use" are not present in this excerpt.

• Data Provenance: Not specified in this document. It does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not available in the provided document. For an FSH Menopausal Test, the "ground truth" for elevated FSH levels would likely be established by a laboratory assay (e.g., ELISA) for quantitative FSH levels, interpreted by a qualified medical professional (e.g., endocrinologist, gynecologist). The document doesn't detail the involvement of experts in establishing the ground truth or their qualifications.

D. Adjudication Method for the Test Set

This information is not available in the provided document. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging or subjective interpretation studies. For a diagnostic test like this, the ground truth is usually established by a reference method (e.g., quantitative laboratory FSH measurement), making multi-reader adjudication less relevant in the same way.

E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates how AI assistance impacts human reader performance, is not applicable to a single-use, qualitative in-vitro diagnostic test like the One Step FSH Menopausal Test. This device is not an AI-assisted interpretation tool.

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

Yes, in essence. This device inherently operates as a "standalone" test. The "performance" figures provided (Positive Agreement, Negative Agreement, Overall Agreement) reflect the device's ability to accurately detect FSH in urine samples, without human intervention in the detection process itself. The "Lay Use" section specifically evaluates its performance when interpreted by non-professionals, which is a key aspect of its standalone functionality for over-the-counter use.

G. The Type of Ground Truth Used

The ground truth used for performance evaluation is indicated by "Clinical Reference" and "Negative Reference" / "Positive Reference." This strongly suggests that the device's results were compared against an established clinical reference method for FSH levels (likely a quantitative laboratory assay) to determine true positive and true negative cases.

H. The Sample Size for the Training Set

This information is not available in the provided document. For a traditional in-vitro diagnostic test, there isn't a "training set" in the machine learning sense. The device's components (antibodies, reagents) are developed and optimized through research and development, but the sample sizes involved in that development process are distinct from the clinical validation (test set) discussed above.

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

Not applicable in the machine learning sense. The "ground truth" for the development of such a test would involve confirming the specificity and sensitivity of the antibodies and reagents against known concentrations of FSH, using established laboratory standards and methods. This is part of the product development and quality control process, rather than a "training set" in AI/ML terminology.

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