Search Results

The Stryker T4/T5 Hytrel Toga is intended to provide a barrier between the operating environment and members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmfill microorganisms. The T4 and T5 Hytrel Togas are sterile, single use only.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Stryker Instruments for their T4/T5 Hytrel Toga, which is classified as "Surgical Apparel." This document does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML powered medical device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... 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 indicates that the device's clearance is based on substantial equivalence to existing devices, usually through demonstrating it meets recognized standards or performs similarly to a predicate, rather than through a novel clinical study with AI performance metrics.

Therefore, I cannot extract the requested information from this document. The questions you've asked are typically relevant for AI/ML-powered diagnostic or prognostic devices, not for surgical apparel cleared via a 510(k) based on substantial equivalence to predicate devices.

Ask a specific question about this device