Search Results

The Stryker T4 Urethane Hood, Zippered Toga, and Pullover Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The Stryker Personal Protection Systems include a self-contained ventilation helmet, a hood, a toga, rechargeable battery, and accessories.

The provided text is a 510(k) summary and FDA clearance letter for a medical device. It describes the device and its intended use, but does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it mention any AI or algorithm performance.

Therefore, I cannot fulfill your request for the specific information you listed (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because that information is not present in the provided document.

The document states:

• Technological Comparison: "Technological characteristics are the same as previously cleared for the Stryker Steri-sheild Personal Protection System (K944393, K993148, K011755)."

This indicates that the device was cleared based on substantial equivalence to a predicate device, meaning it is considered to perform similarly and have similar safety and efficacy profiles as devices already legally marketed. It suggests that specific new performance studies for this iteration of the device were likely not necessary for 510(k) clearance, as its characteristics were deemed identical to previously cleared devices.

Ask a specific question about this device