(246 days)
The SRI/Surgical Express SRI Level III Gowns are reusable gowns 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.
SRI/Surgical Express Level III Gowns are reusable gowns.
My apologies, but the provided text from the FDA 510(k) clearance letter for the "SRI/Surgical Express Level III Gowns" does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML-driven medical device.
This document is a regulatory clearance letter for a physical product (surgical gowns), not a software or AI device. The information typically associated with studies proving AI device performance (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of traditional medical device.
The letter does contain:
- Trade/Device Name: SRI/Surgical Express Level III Gowns
- Regulation Number: 21 CFR 878.4040
- Regulation Name: Surgical Apparel
- Regulatory Class: II
- Product Code: FYA
- Indications for Use: "The SRI/Surgical Express SRI Level III Gowns are reusable gowns 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."
- 510(k) Number: K080707
However, it does not provide any data or details about performance studies in the way you've outlined for an AI/ML device. For a surgical gown, "acceptance criteria" would typically relate to physical properties like barrier protection level (e.g., AAMI Level 3), liquid resistance, tensile strength, sterility, etc., which are usually tested according to recognized standards (e.g., ANSI/AAMI PB70, ASTM F1670, ASTM F1671). The letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying that it meets the same performance standards as those predicates, but it does not detail the specific test results or studies within this document.
§ 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.