(28 days)
The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.
The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, and under various private labels as Early Ovulation Predictor or Ovulation Predictor.
The provided text describes an Ovulation Predictor (cassette) device. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | 99% accuracy |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text only mentions "Laboratory and clinical studies tests."
- Data Provenance: Not explicitly stated. The text does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not mentioned.
- Qualifications: Not mentioned.
4. Adjudication Method for the Test Set:
- The text does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. This device is an in-vitro diagnostic test for qualitative measurement of LH, not an imaging device requiring human reader interpretation in the same way as an MRMC study. The comparison was against a predicate device's performance.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance:
- Was it done?: Yes. The "Summary of Performance Data" states that "Laboratory and clinical studies tests demonstrate that Ovulation Predictor (cassette) provides equivalent performance to the ClearPlan® Easy ovulation test." The reported 99% accuracy is for the device itself.
7. Type of Ground Truth Used:
- The ground truth is implied to be based on the established accuracy and performance of the predicate device (ClearPlan® Easy ovulation test). For ovulation prediction tests, the ground truth for "accuracy" typically refers to the device's ability to correctly identify the LH surge when compared to a reference method or clinical ovulation event. The text does not specify the exact method used to establish ground truth (e.g., direct measurement of LH in a lab setting, correlation with actual ovulation confirmed by other means).
8. Sample Size for the Training Set:
- Not applicable. This device is described as an immunochromatographic assay, not an AI or machine learning model that requires a training set in the conventional sense. Its "training" would be more akin to assay development and optimization rather than machine learning training.
9. How Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a machine learning training set.
§ 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.