(219 days)
The GRI-Alleset ComfortGuard™ Surgical Isolation Gown is a non-sterile disposable, single-use gown intended to protect both the health care worker and patients from the transfer of microorganisms, bodily fluids and particulate matter in moderate risk patient isolations. This gown in not intended for use in an operating room environment and should not be worn during surgical or invasive procedures or when there is a potential for a high risk of contamination.
Additionally, the GRI-Alleset ComfortGuard™ Surgical Isolation Gown meets the requirements defined per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) for AAMI Level 3 barrier protection.
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I am sorry, but the provided text from the FDA 510(k) notification for the ComfortGuard™ Surgical Isolation Gown does not contain any information about an AI/ML-based medical device study or its performance criteria.
The document is a standard FDA clearance letter for a medical device (a surgical isolation gown), confirming its substantial equivalence to a legally marketed predicate device. It discusses regulatory matters such as:
- Device name and product code
- Regulation numbers and class
- General controls provisions of the Act
- Requirements for registration, listing, labeling, and good manufacturing practice
- Adverse event reporting
- Indications for Use
Specifically, concerning performance, it states: "Additionally, the GRI-Alleset ComfortGuard™ Surgical Isolation Gown meets the requirements defined per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) for AAMI Level 3 barrier protection." This refers to a physical barrier standard for gowns, not a performance study of a diagnostic AI/ML algorithm.
Therefore, I cannot extract the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training/test sets) because this type of information is not present in the provided 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.