(109 days)
ADI Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The ADI Medical Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose clamp. The ADI Medical Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. ADI Medical Surgical Face Masks will be provided in blue. ADI Medical Surgical Face Masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text describes the regulatory filing for a surgical face mask, not an AI-powered diagnostic device. Therefore, the questions related to AI device performance, expert ground truth, MRMC studies, and training/test set sample sizes are not directly applicable.
However, I can extract the information relevant to the device's acceptance criteria and the study proving it meets those criteria based on the provided document.
Device: ADI Medical Surgical Face Mask
Regulatory Filing: K213347
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ADI Medical Surgical Face Mask are defined by various ASTM and EN standards for surgical masks. The performance tests were conducted to demonstrate that the device meets these standards.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Test (Standard) | Acceptance Criteria | Reported Device Performance (ADI Medical Surgical Face Mask) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 samples pass at 120 mmHg | 94 out of 96 samples pass at 120 mmHg (from 3 non-consecutive lots) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Average: 99.47% (96 out of 96 samples pass) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Average: 99.48% (96 out of 96 samples pass) | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
§ 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.