Search Results

Multi-Use Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. The test will be marketed for the retail or "over-the-counter" (OTC) market use.

Not Found

This looks like a 510(k) clearance letter for a medical device (Multi-Use Electronic Pregnancy Test). However, the document provided does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

The letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to a "premarket notification" but does not include the actual performance study details from that notification.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Training set sample size
• How ground truth for the training set was established

To provide this information, you would need to find the actual 510(k) submission summary or the detailed study report submitted by Mizuho USA, Inc. to the FDA, not just the clearance letter.

Ask a specific question about this device

Proof Positive Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the qualitative determination of human chorionic gonadotropin (hCG) in urine. The test will be marketed for the retail or "over-the-counter" (OTC) market use.

Not Found

The provided text is a 510(k) premarket notification approval letter for the "Proof Positive Electronic Pregnancy Test." While it states the device has been found substantially equivalent to a predicate device and provides its intended use, it does not contain specific information about acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment that would allow a comprehensive answer to your request. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device