(29 days)
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.
§ 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.