(148 days)
Master & Frank Surgical Gowns (Sterile) are single use article of surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Master & Frank Surgical Gowns (Sterile), is manufactured from non-woven fabric. This surgical Gown is supplied sterile and for single use only.
The provided text is a 510(k) summary for a medical device, specifically Master & Frank Surgical Gowns (Sterile). It outlines the device description, intended use, and a performance summary. However, it does not describe an AI medical device, but rather a physical sterile surgical gown.
Therefore, the requested information regarding acceptance criteria and a study proving a digital device meets those criteria (which would typically involve performance metrics like accuracy, sensitivity, specificity, statistical analysis of a test set, expert adjudication, etc.) is not applicable to this submission.
The "Performance Summary" section of the 510(k) states:
"In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards----etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards.."
This indicates that the acceptance criteria for this physical device are based on compliance with established industry standards for physical properties (like tear strength, tensile strength, flammability), biological safety (biocompatibility), and sterilization. The "study" proving it meets these criteria would typically involve bench testing against these specific material and sterilization standards, rather than the types of studies performed for AI software (e.g., test set evaluations with ground truth derived from expert consensus or pathology).
Since the submission is not for an AI device, I cannot provide the requested details regarding AI-specific criteria.
§ 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.