(63 days)
The Disposable Medical Face Mask is 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear. The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering. This is a single use, disposable device(s), provided non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets those criteria, specifically concerning AI/ML performance metrics, multi-reader multi-case studies, effect size of human readers improving with AI, standalone algorithm performance, and ground truth establishment/training sets, are not applicable.
However, I can extract the acceptance criteria and reported device performance for this medical face mask from the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Discussion |
|---|---|---|---|
| Particulate Filtration Efficiency | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.68%, Lot 2: 99.56%, Lot 3: 99.81% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.926%, Lot 2: 99.93%, Lot 3: 99.936% | Similar (Subject device performance meets or exceeds predicate) |
| Bacterial Filtration Efficiency (BFE) | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.9%, Lot 2: 99.9%, Lot 3: 99.9% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: ≥99%, Lot 2: ≥99%, Lot 3: ≥99% | Similar (Subject device performance meets criteria, although specific values for predicate are higher than the "≥99%" reported for the subject) |
| Differential Pressure | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 3.8 mm H2O/cm², Lot 2: 3.6 mm H2O/cm², Lot 3: 3.7 mm H2O/cm² | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: |
§ 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.