(168 days)
Cardinal Health™ RoyalSilk™ Surgical Gown is a single use, disposable medical device intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70).
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I am sorry, but based on the provided text, there is no information about a medical device that uses AI or machine learning, nor any details about a study to prove its performance or acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA to Cardinal Health LLC regarding their RoyalSilk Surgical Gown and RoyalSilk Scrub Nurse Gown. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
The content focuses on regulatory information, such as:
- The trade/device name and regulation number
- General controls provisions of the Act
- Requirements for registration, listing, labeling, and medical device reporting
- Information about the regulation entitled "Misbranding by reference to premarket notification"
- Links to FDA resources for medical devices
- Indications for Use for the surgical gowns, specifically stating that the Cardinal Health RoyalSilk Surgical Gown meets the requirements of AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or AI performance, as these topics are not present in the provided text.
§ 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.