Search Results

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.

Not Found

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.

Ask a specific question about this device