(125 days)
The medical/surgical masks listed below are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
The new surgical masks are pleated 3-ply masks. The outer layers are made with 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% medical grade tissue paper or 100% SBPP. The ear loops are made of flat latex and fiberglass free elastic. The nosepieces are made of malleable aluminum wire. All of the materials used in the construction of the new masks are being used in currently marketed devices.
The device in question is a Non-Sterile Surgical Mask manufactured by A.R. Medicom Inc. The filing is a 510(k) Summary, indicating a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the traditional sense of AI/medical imaging device performance.
Therefore, the "acceptance criteria" for a surgical mask are typically based on recognized performance standards, which in this case is ASTM F2100-04, "Standard Specification for Performance of Materials Used in Medical Face Masks." The "study" that proves the device meets these criteria would involve various material and barrier property tests, not a clinical trial with human readers or AI.
Given the nature of the device (a surgical mask) and the provided document (a 510(k) Summary for a medical device cleared in 2005), many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, AI standalone performance, training set details) are not applicable as they pertain to the evaluation of AI/software as a medical device or diagnostic imaging devices, not a physical barrier device like a surgical mask.
However, I will address the relevant aspects based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For surgical masks, "acceptance criteria" and "reported device performance" are typically defined by recognized consensus standards. In this case, ASTM F2100-04 is listed as the recognized performance standard. This standard categorizes masks into different levels based on their performance in a series of tests. While the exact performance levels for this specific mask are not detailed in the provided 510(k) summary (only the standard itself is mentioned as being applicable), the various tests and their criteria from ASTM F2100-04 are implied to be the 'acceptance criteria'.
The 510(k) summary states that the device is "substantially equivalent" to predicate devices K955513 and K040333, implying it meets similar performance standards. The device's description (3-ply, spun-bound polypropylene outer layers, melt-blown polypropylene filter media, medical grade tissue paper or SBPP inner layer) strongly suggests the materials are chosen to meet these performance characteristics.
| Test Parameter from ASTM F2100-04 (Implied Acceptance Criteria) | Reported Device Performance (Implied from 510(k) based on substantial equivalence to predicate and meeting ASTM F2100-04) |
|---|---|
| Bacterial Filtration Efficiency (BFE) | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., ≥95% or ≥98%) |
| Particle Filtration Efficiency (PFE) | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., ≥95% or ≥98% at 0.1 micron) |
| Fluid Resistance | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., 80, 120, or 160 mmHg) |
| Differential Pressure (Breathability) | Not explicitly stated, but expected to meet ASTM F2100-04 specified level (e.g., |
§ 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.