(113 days)
The Procedure mask/Surgical 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, provided non-sterile.
The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.
The provided text is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). It details non-clinical tests conducted to prove substantial equivalence to a predicate device, rather than the development and validation of an AI-powered diagnostic device.
Therefore, I cannot extract information related to:
- Study that proves the device meets acceptance criteria: The document describes non-clinical performance testing of a physical product (face mask) against established standards, not an AI model's performance.
- Sample size used for the test set and data provenance: No test set of patient data, images, or cases is mentioned. The tests are on material properties of the mask.
- Number of experts used to establish ground truth and qualifications: Ground truth for a face mask's performance is established by standardized physical and biological tests, not expert consensus on medical images or patient data.
- Adjudication method for the test set: Not applicable as there's no diagnostic test set requiring adjudication.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human reader performance with and without AI assistance for interpretation tasks.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to the measured physical and biological properties of the mask.
- Sample size for the training set: There is no training set mentioned, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Instead, I can present the acceptance criteria and reported device performance from the non-clinical tests for the traditional medical device (face mask) as provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Result (Proposed Device) |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M: 2017) | To evaluate the effectiveness of the test article from possible exposure to blood and other body fluids. | Level 1: No penetration at 80 mmHg | Level 1: Pass at 80mmHg |
| Level 2: No penetration at 120 mmHg | Level 2: Pass at 120mmHg | ||
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017)) | To determine the particle filtration efficiency (PFE) of the test article. | Level 1: ≥95% | Blue mask: Pass at 96.05% |
| Black mask: Pass at 96.03% | |||
| Level 2: ≥98% | Blue mask: Pass at 98.78% | ||
| Black mask: Pass at 98.75% | |||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101: 2019) | To determine the bacterial filtration efficiency (BFE) of the test article. | Level 1: ≥95% | Blue mask: Pass at 98.25% |
| Black mask: Pass at 98.25% | |||
| Level 2: ≥98% | Blue mask: Pass at 98.72% | ||
| Black mask: Pass at 98.73% | |||
| Differential Pressure (EN 14683:2019+AC: 2019 Annex C) | To determine the differential pressure of the test article. | Level 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.