(134 days)
The Procedure 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 to blood and body fluids. All models are single use, disposable devices, provided non-sterile.
Model GFM31A Procedure Mask will be provided with a nose wire for general medical use, and without a nose wire for use in an MRI environment. This model of Procedure Mask is manufactured with three layers. The user facing layer is made of white polypropylene spunbond; the filtration/middle layer is made of white polypropylene meltblown; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire, when present, is used to fit the facemask around the user's nose. The product intended to be used in an MRI environment is constructed with the same materials except for the nose wire. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
Model GFM42A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
Model GFM43A Procedure Mask is manufactured with four layers. The user facing layer is made of white polypropylene spunbond; the filtration layer is made of white polypropylene meltblown; the next layer is made of blue polypropylene spunbond; and the outer layer is made of blue polypropylene spunbond. The ear loops are welded to the mask and are used to keep the mask close to the mouth and the nose. This device is not made with natural rubber latex. The PVC coated nose wire is used to fit the facemask around the user's nose. The Procedure Mask is to be provided as a non-sterile, single use, disposable device.
The provided document contains information on the acceptance criteria and performance testing for a medical device (Procedure Mask). However, it does not include information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML or diagnostic devices, such as:
- Sample size for a test set (it mentions testing on "three non-consecutive production lots" for the ASTM performance tests, which refers to the mask itself, not a dataset for an AI model).
- Data provenance for the test set.
- Number of experts or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Effect size of human readers improving with AI assistance.
- Standalone performance (for an AI algorithm).
- Type of ground truth (beyond the mask's physical performance).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is for a Procedure Mask, a physical medical device, not an AI/ML-driven diagnostic or image analysis device. Therefore, the questions related to AI/ML study design are not applicable to the information contained in this document.
The acceptance criteria here pertain to the physical and functional performance of the mask as per relevant ASTM and ISO standards for medical face mask materials and biocompatibility.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM F2100 levels (Level 1, Level 2, Level 3) which define performance requirements for medical face masks. The tables within the document compare the proposed device's performance to the predicate device's performance against these standards.
Model GFM31A (ASTM Level 1)
| Performance Test | Acceptance Criteria (from ASTM F2100 Level 1) | Reported Device Performance (GFM31A) | Reported Predicate Performance (KC200/Y01) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥ 80 mmHg | 32 out of 32 passed at 80 mmHg (3 lots) | Meets Performance Requirements at 120 mm Hg (KC200); 32 out of 32 pass at 80 mmHg (Y01) | All Meet Requirements |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | 99.89%, 99.84%, 99.80% | 98.4% (KC200); 99.12%, 99.45%, 99.56% (Y01) | All Meet Requirements |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | 99.80%, 99.71%, 99.81% | 99.7% (KC200); 99.92%, 99.93%, 99.92% (Y01) | All Meet Requirements |
| 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.