Search Results

A non-metal disposable vaginal speculum is an instrument that is used to expose the interior of the vagina.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Cypress Medical Products regarding their Disposable, Non-Metal Vaginal Speculum. This type of document confirms substantial equivalence to a legally marketed predicate device, but it does not contain the detailed study results, acceptance criteria, or ground truth information requested in your prompt.

Specifically, the letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's performance was compared to existing, legally marketed devices, but the specifics of those comparative studies (acceptance criteria, sample sizes, ground truth establishment, etc.) are not described in this letter. A 510(k) submission generally includes this information, but the letter itself is just the FDA's decision.

Therefore, I cannot provide the requested table and study details based solely on the text given. The document does not describe a new study proving the device meets specific acceptance criteria in the manner you've outlined. 510(k) clearance is typically based on demonstrating substantial equivalence, often through a combination of design characteristics, materials specifications, and sometimes limited performance data compared to a predicate, rather than a full-scale clinical trial with detailed acceptance criteria and ground truth as might be seen for novel AI/diagnostic devices.

Ask a specific question about this device