(85 days)
The Medline Reusable Surgical Gown is intended to be used by operating room personnel du surgical procedures to help protect both the patient and the health care worker from transfer mirco-organisms, body fluids, and particulate material.
Medline Reusable Surgical Gowns (100X)
This document is a 510(k) premarket notification letter for a medical device, specifically Medline Reusable Surgical Gowns. It is not a study report or a technical document detailing the performance of an AI/ML powered device.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies or standalone performance cannot be extracted from the provided text.
The document confirms that the FDA has determined the Medline Reusable Surgical Gowns are "substantially equivalent" to legally marketed predicate devices, allowing them to be marketed. This determination is based on the device meeting the existing regulatory framework for surgical apparel (Regulation Number: 878.4040, Product Code: FYA).
The letter does include an "Indications for Use" statement, which typically describes what the device is intended for, but does not provide performance metrics or acceptance criteria in the manner requested for an AI/ML study.
In summary, none of the requested information regarding acceptance criteria and a study to prove device performance (especially in the context of AI/ML) is present in the provided FDA 510(k) letter.
§ 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.