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510(k) Data Aggregation
(169 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 Mask is composed of mask body, nose clip and ear loops. The body of the mask is composed of three layers: the inner and outer layers are made of Spun-bond polypropylene, and the middle layer is made of melt blown non-woven fabric, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex. The size of the Surgical Face Mask is 17.5*9.5cm with tolerance ± 5% cm, the length of the ear loopis 16cm, and the length of the nose clip should no less than 8.0cm. The outer layer of Surgical Face Mask will be provided in blue, the inner layer of the Surgical Face Mask will be provided in white. The Surgical Face Mask will be provided non-sterile and is intended to be single use.
The document describes the non-clinical performance testing of a Surgical Face Mask (Trade/Device Name: Surgical Face Mask, Model: TY123, K212059) to demonstrate its substantial equivalence to a legally marketed predicate device (K182514).
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Subject device Performance | Acceptance Criteria (Level 2) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | No penetration at 120 mmHg | No penetration at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | >99.16% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | 99.9% | ≥ 98% | Pass |
| Differential Pressure (Delta P) EN 14683 Annex C | <5.3mmH2O/cm² | <6.0mmH2O/cm² | Pass |
| Flammability 16 CFR 1610 | Class 1 | Class 1 | Pass |
Biocompatibility tests (Cytotoxicity, Irritation, Sensitization according to ISO 10993-5 and ISO 10993-10) also concluded that the device is non-cytotoxic, non-irritating, and non-sensitizing, which aligns with the predicate device's characteristics.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of masks tested for fluid resistance, filtration efficiency, etc.). The provenance of the data is from non-clinical laboratory testing, not human patient data. Therefore, country of origin or retrospective/prospective classification is not applicable in the context of patient data. These are laboratory test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is established by standardized laboratory test results against predefined performance metrics, not by expert interpretation of medical images or clinical data.
4. Adjudication method for the test set
Not applicable. The tests are objective laboratory measurements, not subjective evaluations requiring 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
Not applicable. This is a medical device (surgical face mask) clearance, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is based on established international and national standards for medical face masks and biological evaluation of medical devices. These standards define the acceptable physical and biological performance characteristics. Examples of standards used include ASTM F2100, ASTM F1862, EN 14683, ASTM F2101, ASTM F2299, 16 CFR 1610, ISO 10993-5, and ISO 10993-10.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence. This is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
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