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510(k) Data Aggregation
(442 days)
The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The subject device includes six mask models. Each mask is composed of four-layers (outer non-woven layer, support layer, melt blown filter layer, and inner non-woven layer). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The masks are single use, disposable devices, provided non-sterile. These devices are not made from Natural Rubber Latex.
The provided text is a 510(k) summary for surgical masks, not an AI/ML-enabled medical device. Therefore, the information requested in your prompt regarding AI/ML performance metrics, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.
However, I can extract the acceptance criteria and non-clinical study results for these surgical masks, as presented in the document.
Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Surgical Masks)
The non-clinical tests were conducted to verify that the proposed device met design specifications and complied with relevant standards. The tests align with ASTM F2100 Level 3 barrier requirements.
| Performance Testing | Test Methodology | Acceptance Criteria: Level 3 Barrier | Reported Device Performance |
|---|---|---|---|
| Particulate Filtration Efficiency (PFE) | ASTM F2299-17 | ≥98% | Passed at ≥ 98% @ 0.1 micron |
| Fluid Resistance | ASTM F1862-17 | Pass at 160 mmHg | Passed at 160mm Hg |
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥98% | Passed at ≥ 98% |
| Differential Pressure (Breathability) | EN 14683:2019 Annex C | <6 mmH2O/cm² | Passed at < 6.0 mm H2O/cm² |
| Flammability | 16 CFR Part 1610-2008 | Class 1 | Passed: Class 1 |
Biocompatibility Testing
| Biocompatibility Evaluation | Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| In Vitro Cytotoxicity Test | ISO 10993-5: 2009 | Non-cytotoxic | Non-cytotoxic |
| Skin Sensitization Test | ISO 10993-10: 2010 | Non-sensitizing | Non-sensitizing |
| Skin Irritation Test | ISO 10993-10: 2010 | Non-irritating | Non-irritating |
| Systemic Toxicity Test (Acute Systemic Toxicity) | ISO 10993-11: 2017 | Non-acute systemic toxicity | Non-acute systemic toxicity |
Information Not Applicable to This Document (AI/ML-specific questions):
- Sample size used for the test set and the data provenance: Not applicable. This document describes physical device testing, not data-driven AI model testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for masks is established by standardized laboratory testing.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Standardized physical and biological test methods defined by ISO and ASTM standards (e.g., measuring filtration efficiency, fluid resistance, cellular response).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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