(209 days)
MAF Guard is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops or tie-on strings and a nose piece. The mask is 175 ± 5 mm by 95 ± 3 mm. The outer, blue layer and the inner, white layer are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. One model of the mask is secured to the face with two ear loops made of polyester Spandex that are 150 ± 10 mm long. The other model is secured with four spin bond polypropylene tie-on strings that are 450 ± 10 mm long. A nosepiece of steel core wire coated with polyethylene resin that is 110 ± 5 mm long conforms the mask to the shape of the nose.
The provided document is a 510(k) Summary for a surgical face mask (MAF Guard). It describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria for an AI/algorithm-based medical device.
Therefore, most of the requested information regarding AI/algorithm performance, such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, is not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical characteristics and filtration efficacy of the surgical mask based on the provided tables.
Here's the information that can be extracted from the document, focusing on the appropriate acceptance criteria and "study" (non-clinical testing) for a surgical mask:
Device: MAF Guard Surgical Face Mask (Ear Loop model SM3P-MB25-2511; Tie-on model SM3P-MB25-2521)
Device Type: Surgical Face Mask
Regulatory Class: Class II
Product Code: FXX
Predicate Device: Non Woven Face Mask (K173062)
The study described is non-clinical performance testing to demonstrate that the MAF Guard surgical face mask meets established consensus standards for surgical masks, aligning with the "Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004."
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test Method (Standard) | Purpose | Acceptance Criteria (for Level 3 Surgical Mask) | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Evaluate resistance to penetration by synthetic blood, minimum pressure in mm Hg | Level 3 requirement: 29 out of 32 passed at 160 mm Hg | 32 out of 32 passed at 160 mm Hg for three non-consecutive lots | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Evaluate Sub-micron particulate filtration efficiency at 0.1 micron (%) | Level 3 requirement: ≥ 98% | Mean for three non-consecutive lots = 99.88%, 99.89%, and 98.50% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | Evaluate BFE using a biological aerosol of Staphylococcus aureus (%) | Level 3 requirement: ≥ 98% | Mean for three non-consecutive lots = 98.9%, 98.5%, and 98.4% | Pass |
| Differential Pressure (Delta P) (EN 14683) | Evaluate Differential pressure (mm H2O/cm²) | Level 3 requirement: |
§ 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.