(34 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, an under various private labels as One Step 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, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor. The technological characteristics are the same because both devices are One-step urine tests that measure LH immunochromatographically, and have the same safety and effectiveness.
The provided text describes the K991386 submission for the Early Ovulation Predictor (stick), One Step Ovulation Predictor (stick), and Ovulation Predictor (stick). Here's a breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 99% accuracy | 99% accuracy |
Explanation: The document explicitly states, "Both devices are 99% accurate," referring to the new device and the predicate device. This establishes the 99% accuracy as the critical performance metric for substantial equivalence.
Study Information:
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document generally refers to "clinical studies tests" without providing specific numbers for the test set.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the nature of clinical studies in enough detail to determine how ground truth was established, nor does it mention experts.
3. Adjudication method for the test set:
- Not specified. There is no information regarding any adjudication process for the test set.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is an in-vitro diagnostic (IVD) for home use, which typically does not involve human readers in the same way an imaging AI device would. The core claim is about the device's ability to detect LH levels, not about assisting human interpretation of complex medical data.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, by nature. The device is a "One-step urine test that measure LH immunochromatographically," intended for home use by women. It provides a direct result (qualitative measurement of LH), meaning its performance is inherently standalone, without a "human-in-the-loop" to interpret an algorithm's output. The comparison is between the new device and a predicate device, both operating as standalone tests.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied ground truth related to LH detection. While not explicitly stated, the ground truth would likely be established through a validated laboratory method for measuring Luteinizing Hormone (LH) levels in urine. This would serve as the reference standard against which both the new device and the predicate device's results are compared to determine their "accuracy" in detecting LH surge.
7. The sample size for the training set:
- Not specified. The document only mentions "Laboratory and clinical studies tests" without detailing training sets.
8. How the ground truth for the training set was established:
- Not specified. As the training set size and characteristics are not provided, the method for establishing its ground truth is also unknown. It would presumably involve similar laboratory methods for LH detection as the ground truth for the test set.
In summary, the provided submission focuses on establishing substantial equivalence to a predicate device (ClearPlan® Easy ovulation test) based on identical technological characteristics and demonstrated equivalent performance (99% accuracy) through laboratory and clinical studies. However, detailed methodological information regarding sample sizes, ground truth establishment, and study design elements common in more complex AI/imaging device submissions is largely absent.
§ 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.