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510(k) Data Aggregation
(373 days)
The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.
The proposed Surgical Face Mask is a non-sterile, single-use, 3-layer mask with outer and inner facing layers comprised of white spun-bond polypropylene and a middle layer comprised of white melt blown polypropylene. The mask is secured to the user via nylon/spandex ear loops that are ultrasonically welded to the mask. This mask does not contain any natural rubber latex. The device also contains a nose wire made of a pliable steel strip, coated in polypropylene, that helps to form the mask around the user’s nose.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM F2100-19 Level 3) | Reported Device Performance (K201844) | Predicate Device Performance (K201479) |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 160 mmHg | Pass | Pass |
| Particulate Filtration Efficiency (ASTM F2299, 0.1 micron) | ≥ 98% | Avg. 99.0% | ≥ 99% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Avg. 99.1% | ≥ 99% |
| Differential Pressure (EN 14683:2019, Annex C) | < 5.0 mmH2O/cm^2 | Avg. 4.9 mmH2O/cm^2 | Avg. 3.6 mmH2O/cm^2 (MIL-M36954C) |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Pass (Cytotoxicity, Irritation, Sensitization) | Pass | Pass |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for each specific test. However, it indicates that "the proposed Surgical Face Masks have been tested according to ASTM F2100-19, the relevant standards which comprise ASTM F2100-19, and ISO 10993." These standards typically specify the number of samples required for each test.
The data provenance is from nonclinical testing performed on the "proposed Surgical Face Mask" (K201844). No information is provided regarding the country of origin of the data or if it was retrospective or prospective, though nonclinical performance testing is generally prospective in nature.
3. Number of Experts and Qualifications
This submission pertains to the performance testing of a physical medical device (surgical face mask) against established industry standards (ASTM, ISO). Expert interpretation of images or other subjective data is not relevant here. The ground truth for these tests is based on objective, quantifiable measurements performed according to standardized protocols.
4. Adjudication Method
Not applicable. The tests are objective measurements against defined criteria. There is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a submission for a physical device, not an AI software or system that requires human-in-the-loop performance evaluation.
6. Standalone Performance Study
Yes, a standalone study was done. The entire summary outlines the results of the performance testing of the proposed Surgical Face Mask (K201844) without any human interaction beyond setting up and executing the standardized tests.
7. Type of Ground Truth Used
The ground truth for this study is based on objective measurements obtained through standardized testing protocols. Each test (e.g., fluid resistance, BFE, PFE, differential pressure, flammability, biocompatibility) has specific, quantifiable metrics that define "pass" or "fail" according to the relevant ASTM, EN, and ISO standards.
8. 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 whose performance is evaluated through laboratory testing.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/machine learning device, there is no training set and therefore no ground truth established for a training set.
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