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The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid to conception by accurately and reliably predicting ovulation via a urine test. The CLEARPLAN EASY Ovulation Test detects the LH surge in a woman's urine. The product will be made available over-the-counter through pharmacies and drug stores.

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The provided document is a 510(k) clearance letter from the FDA for the "CLEARPLAN EASY Ovulation Test". It does not contain any information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the performance metrics of the device. It simply states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval letter, not a technical report or study summary.

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