(44 days)
FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the detection of Follicle Stimulating Hormone (FSH) in urine to be used as an aid in predicting menopause. The FSH Menopause Predictor Test is intended for over-the-counter use by the lay consumer.
The FSH Menopause Predictor Test is a midstream test used for the qualitative measurement of FSH and the detection of Follicle Stimulating Hormone in a woman's urine as an aid in predicting menopause. The FSH predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. FSH Menopause Predictor is an over-the-counter (OTC) device and may be sold under various private labels.
Here's a breakdown of the acceptance criteria and study details for the ACON Laboratories Inc. FSH Menopause Predictor Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Accuracy (ACON FSH Menopause Predictor Test (trained Lab Tech) vs. InstaCheck®) | >99% (99% - 99% CI) | This appears to be the primary criterion for substantial equivalence to the predicate device when used by trained personnel. Due to rounding, the confidence interval is very narrow. |
| Accuracy (ACON FSH Menopause Predictor Test (consumer) vs. ACON FSH Menopause Predictor Test (trained Lab Tech)) | 94% (92.1% - 95.6% CI) | This criterion assesses the performance of the device when used by the intended lay consumer compared to a trained professional using the same device. This demonstrates user-friendliness and reliability in the intended OTC environment. |
| Accuracy (ACON FSH Menopause Predictor Test (Consumer) vs. InstaCheck®) | 94% (92.1% - 95.6% CI) | This criterion directly compares the consumer-used device to the predicate device, reflecting overall consumer performance against the established standard. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 70 females.
- Data Provenance: The study was a prospective clinical trial as participants conducted tests at home according to instructions, and urine samples were collected for testing by a study coordinator. The location of the study (e.g., country of origin) is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth in this study was established using a substantially equivalent product (InstaCheck®) and the ACON FSH Menopause Predictor Test used by a trained lab tech.
- The text refers to a "trained Lab Tech," implying a professional with specific training in operating such devices. No further details on the qualifications (e.g., years of experience, specific certifications) are provided for this "trained Lab Tech."
4. Adjudication Method for the Test Set
- The text describes a comparison study rather than an adjudication process for a single ground truth. The "adjudication" was effectively done by comparing the results of the ACON FSH Menopause Predictor Test (both consumer-used and lab tech-used) against the InstaCheck® device. The data obtained from both devices were recorded as "Negative or Positive" without mention of an adjudication panel resolving discrepancies between the devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a traditional MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. This device is a diagnostic test kit, not an AI-powered diagnostic imaging tool that would typically involve radiologists or other human readers interpreting complex images.
- However, the study does compare performance between the "trained Lab Tech" and the "consumer" using the ACON device, which could be seen as a form of multi-user comparison, albeit without an AI component. There is no "effect size of how much human readers improve with AI vs without AI assistance" as AI assistance is not part of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance was done in the sense that the ACON FSH Menopause Predictor Test (when operated by a trained lab tech) was evaluated for its accuracy against the InstaCheck® product. This represents the device's inherent performance under controlled conditions. The "consumer" arm of the study also represents a standalone performance of the device in the hands of its intended user.
7. The Type of Ground Truth Used
- The ground truth used was comparative performance against a legally marketed predicate device (InstaCheck®) and the device itself when operated by a trained professional. While not explicitly "pathology" or "outcomes data" in the traditional sense, the InstaCheck® device serves as an established clinical reference for FSH levels in this context. The study also uses the ACON device operated by a trained professional as a reference for assessing consumer performance.
8. The Sample Size for the Training Set
- The provided text does not specify a training set sample size. This is likely because the FSH Menopause Predictor Test is a chemical-based in vitro diagnostic, not a machine learning or AI-driven device that requires a separate training set for algorithm development. The performance data presented are from a clinical trial (test set) designed to validate the device's performance.
9. How the Ground Truth for the Training Set Was Established
- As there's no mention of a training set in the context of AI or machine learning for this device, a separate ground truth establishment method for a training set is not applicable based on the provided information. The device's mechanism is based on antibody-antigen reactions, not on learned patterns from a large dataset.
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.