(643 days)
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.
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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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.