(195 days)
Fertilité OV™ (PSC Fertility Monitor) is an over-the-counter ("OTC") in vitro diagnostic ("IVD") device intended for use by women as an aid in conception by measuring hormone-induced changes in the composition of the perspiration on the skin during the menstrual cycle. Properly used, it gives more notice for conceiving and is not invasive. It is NOT to be used for contraception.
The PSC Fertility Monitor consists of a small wristwatch that houses an interactive microprocessor and a biochemical sensor. The device measures chloride ion levels in female sweat from the skin surface in order to predict current fertility status by displaying the result on the screen. The device provides the user with notice up to four days before ovulation during which the user may have the greatest chance of becoming pregnant.
Here's an analysis of the acceptance criteria and study detailed for the PSC Fertility Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds). Instead, the performance is described in a comparative manner against existing methods.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Clinical usefulness as a non-invasive method of predicting impending ovulation. | Predicted ovulation better than basal body temperature (BBT). |
| Comparability to legally marketed fertility monitors. | Predicted ovulation almost as well as LH levels in urine. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 female research participants.
- Data Provenance: Prospective clinical study. The country of origin is not explicitly stated, but the submitter is based in Toronto, Ontario, Canada.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the text. The ground truth was established by clinical measurements rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth was established by direct clinical measurements of serum LH levels, not by a panel of experts adjudicating interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compared different fertility monitors (devices measuring different parameters) against a common objective ground truth (serum LH levels), not different human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study evaluated the standalone performance of the PSC Fertility Monitor (and other monitors) directly against serum LH levels. This device is an "over-the-counter" device, implying it provides direct output to the user without a human expert interpreting the device's reading or interacting with an algorithm.
7. The Type of Ground Truth Used
The ground truth used was serum LH levels, which represents an objective clinical measurement.
8. The Sample Size for the Training Set
The text does not mention a separate training set or its sample size. The clinical study described appears to be a validation study for the device's performance. It's common for medical devices, particularly those involving biochemical measurements, to have algorithms or calibration developed prior to a clinical validation, but the details of any such training data are not included here.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned, the method for establishing its ground truth is not provided.
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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.