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The Distinct® Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid for the early detection of pregnancy. This test can help determine if you are pregnant as early as 6 days before the day of the missed period (5 days before the day of your expected period).

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This letter is an FDA clearance letter and does not contain the detailed information necessary to answer all the questions about the acceptance criteria and the study proving the device meets them. The letter confirms that the Distinct® Digital Pregnancy Test has been found substantially equivalent to predicate devices and can be marketed.

However, based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The clearance letter does not provide a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, accuracy, etc. These details would typically be found in the 510(k) submission summary or the device's labeling (instructions for use).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the FDA clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the FDA clearance letter. Since this is an over-the-counter diagnostic test for hCG in urine, the "ground truth" for a pregnancy test is typically established by laboratory methods that accurately quantify hCG levels, rather than interpretation by a panel of medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the FDA clearance letter.

5. 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

This information is not present in the FDA clearance letter. This device is a "Distinct® Digital Pregnancy Test," implying it's a test that gives a digital readout (e.g., "Pregnant" or "Not Pregnant"). It's unlikely to be an AI-assisted diagnostic tool that requires human reader interpretation in the context of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not explicitly stated as an "algorithm only" study. However, as an over-the-counter digital pregnancy test, its performance is inherently standalone, meaning the user follows instructions and the device provides the result without further human interpretation beyond reading the digital display. The device itself is the "algorithm" in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a pregnancy test like this would be established by quantitative laboratory analysis of human chorionic gonadotropin (hCG) levels in urine or blood, which is the gold standard for confirming pregnancy. The letter mentions the test is for "qualitative detection of human chorionic gonadotropin (hCG) in urine."

8. The sample size for the training set

This information is not present in the FDA clearance letter.

9. How the ground truth for the training set was established

This information is not present in the FDA clearance letter. However, similar to the test set, the ground truth for the training set (if applicable for a digital test that might use some internal calibration or digital processing) would also be established through reference methods for detecting and quantifying hCG.

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