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510(k) Data Aggregation
(257 days)
The Surgical Face 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. This is a single use, disposable device(s), provided non-sterile.
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond 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 piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The surgical face masks will be provided in yellow. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Surgical Face Mask. It outlines the acceptance criteria and performance data for the device, which is a Class II device intended to protect both patients and healthcare personnel from microorganisms, body fluids, and particulate material.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance (%) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | $\geq$ 98% | 99.7% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | $\geq$ 98% | 99.9% | Pass |
| Differential Pressure (Delta P) (MIL-M-36954C) | < 5.0 mmH2O/cm² | 4.0 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1, Non-Flammable | Pass |
The device also underwent biocompatibility testing:
- Cytotoxicity: Accepted as non-cytotoxic. Device was reported as non-cytotoxic.
- Irritation: Accepted as non-irritating. Device was reported as non-irritating.
- Sensitization: Accepted as non-sensitizing. Device was reported as non-sensitizing.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the total sample size for all tests. However, for Fluid Resistance testing, a sample size of 32 devices was used. The document does not specify the country of origin for the data or whether it was retrospective or prospective, but it implies the tests were conducted for the purpose of this submission (prospective testing for the specific device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes performance testing of a physical medical device (surgical face mask) against established engineering standards (e.g., ASTM, MIL-M, CFR). The "ground truth" here is not established by human experts in the sense of clinical image interpretation or diagnosis. Instead, it is determined by the results of standardized laboratory tests conducted according to defined protocols. There is no mention of human expert adjudication for these particular device performance tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based and yield quantitative or categorical results based on established standards, not requiring human adjudication in the traditional sense of consensus among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document states: "No clinical study is included in this submission." The evaluation is based on non-clinical performance testing against established standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-based device. It is a physical medical device (surgical face mask). The performance evaluation is for the device itself, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on established engineering standards and regulatory requirements (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610) for surgical face mask performance, along with biocompatibility testing standards. The device's performance is measured against these objective criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product, and its performance is evaluated through testing of manufactured units.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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