(182 days)
THE SURGICAL FACE MASK 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 MICRO-ORGANISMS, BODY FLUIDS AND PARTICULATE MATERIAL.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a surgical face mask (Megatech Surgical Mask). This type of document does not contain the acceptance criteria or a study detailed to prove the device meets acceptance criteria in the way requested for medical device software or AI systems.
Instead, for physical devices like a surgical mask, the "acceptance criteria" are typically related to performance standards like bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, breathability, and flammability. The "study" to prove meeting these criteria would be laboratory testing against recognized standards (e.g., ASTM F2100). The 510(k) clearance itself indicates that the device has been found substantially equivalent to a legally marketed predicate device, implying it meets the same general performance and safety standards.
Therefore, I cannot extract the requested information from this document. The questions posed are most relevant to device performance studies, particularly for diagnostic software, AI, or imaging devices, where sensitivity, specificity, accuracy, and expert review are critical components of the validation process.
§ 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.