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Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is 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. The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/ AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Surgical Gown with ASSIST™ Instrument Pockets is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user

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This FDA 510(k) clearance letter pertains to a surgical gown, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not present in the provided text.

The document discusses the regulatory clearance of a physical medical device: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets.

Here's what the document does provide regarding the device and its compliance:

• Regulation Number: 21 CFR 878.4040
• Regulation Name: Surgical Apparel
• Regulatory Class: Class II
• Product Code: FYA
• Intended Use: 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.
• Performance Standard: The gowns meet the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. This reference to AAMI Level 4 and ANSI/AAMI PB70 is the primary "acceptance criterion" mentioned, indicating the device's barrier performance.

Since this is a traditional medical device, not an AI/ML product, the questions related to AI/ML specific criteria (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.

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