(225 days)
Plus Medical Cover Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. The gowns are single use and disposable medical device provided sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 1135-1.
Plus Medical Cover Gowns meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
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The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "Plus Medical Cover Gown." This document pertains to the regulatory clearance of a physical medical device (surgical gown) and does not contain information about a software-as-a-medical-device (SaMD) or an AI/ML-based device.
Therefore, I cannot extract the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, or training sets, as these concepts are specifically relevant to the evaluation of AI/ML algorithms, not to the physical characteristics and testing of a surgical gown.
The document primarily focuses on:
- The device name: Plus Medical Cover Gown
- Regulation number and name: 21 CFR 878.4040, Surgical Apparel
- Regulatory class: Class II
- Product Code: FYA
- Indications for Use: Intended to be worn by healthcare professionals to protect both patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate matters.
- Sterilization: Single use and disposable, provided sterile or sold in bulk for EtO sterilization.
- Performance standard cited: AAMI Level 4 per ANSI/AAMI PB70:2012 for liquid barrier performance.
To answer your request, I would need a document detailing the evaluation of an AI/ML medical device, typically a clinical performance study report or a 510(k) summary for such a device.
§ 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.