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510(k) Data Aggregation
(165 days)
The 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). 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 mask is a single use, disposable device, provided non-sterile.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria for ASTM Level 2 | Reported Device Performance (Surgical Mask - K203064 Level 2) | Acceptance Criteria for ASTM Level 3 | Reported Device Performance (Surgical Mask - K203064 Level 3) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | Pass @ 120 mmHg | Pass @ 120 mmHg | Pass @ 160 mmHg | Pass @ 160 mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ 99.8% | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ 99.8% |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ >99% | ≥ 98% (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ >99% |
| Differential Pressure (EN 14683:2019 Annex C) | < 6.0 mm H₂O/cm² (Implied by equivalence to predicate or general ASTM standards for Level 2) | Pass @ 5.1mm H₂O/cm² | < 6.0 mm H₂O/cm² (Implied by equivalence to predicate or general ASTM standards for Level 3) | Pass @ 5.1mm H₂O/cm² |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 | Class 1 | Class 1 |
| Biocompatibility (ISO10993-1, -5, -10) | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing | Non-cytotoxic, Non-irritating, Non-sensitizing |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document for the performance tests. The document only mentions that the device "meets the requirements" or "Passed" these tests. For Biocompatibility testing, the document states "No cytotoxicity or cell lysis was noted" and "No evidence of sensitization or irritation was observed," implying a sufficient number of samples were tested to reach these conclusions, but the exact number isn't given.
- Data Provenance: Not specified. The tests are referred to as "Non-Clinical Performance Testing," suggesting they were conducted in a laboratory setting, not on human subjects. There's no mention of country of origin for the data or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical mask, and the evaluation relies on technical performance standards (ASTM, EN, CFR, ISO) rather than expert interpretation of images or clinical outcomes. The "ground truth" is defined by the passing criteria of the specified standards.
4. Adjudication method for the test set:
- Not applicable. The "ground truth" is determined by meeting the objective pass/fail criteria of the specified technical standards, not through expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This is a surgical mask, not an AI-powered diagnostic device, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (surgical mask), not an algorithm or AI system. The performance tests are for the physical properties of the mask.
7. The type of ground truth used:
- Objective Technical Standards/Specifications: The ground truth for this device's performance is established by its ability to meet the quantitative and qualitative criteria defined by recognized standards such as ASTM F1862-17, ASTM F2299, ASTM F2101-19, EN 14683:2019 Annex C, 16 CFR Part 1610, and ISO 10993 series for biocompatibility.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
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