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Perfecta Pregnancy Test is a pregnancy test intended for home use.

Perfecta Pregnancy Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

The provided text describes a 510(k) summary for the "Perfecta™ Pregnancy Test" by Wyntek Diagnostics Inc. While it outlines the product's intended use, description, and claims of substantial equivalence, it does not contain specific information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot fulfill your request for the detailed table and study information based on the input provided. The text lacks:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used for test or training sets.
• Training set sample size or how its ground truth was established.

The document primarily focuses on regulatory submission details like contact information, product name, intended use, and substantial equivalence claims, without delving into the specifics of performance validation studies.

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