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The Insure Pro Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request. The document is an FDA 510(k) clearance letter for the "InSure Pro Test," confirming its substantial equivalence to a predicate device for the detection of early pregnancy.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Details about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report or clinical trial summary. To answer your questions, you would need to refer to the actual 510(k) submission document (K992695) itself, which would contain the performance data and study details.

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