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510(k) Data Aggregation
(316 days)
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
The medical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
The provided text describes the regulatory clearance for a Medical Face Mask (K210679) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device (K200847). This is a submission for a physical medical device, not an AI/ML-driven device, so many of the requested elements for AI/ML studies are not applicable.
Here's a breakdown of the information that is available and a note on the missing information, tailored to the AI/ML context of your request:
Acceptance Criteria and Reported Device Performance
The device is a medical face mask, and its performance is evaluated against established standards for materials used in such masks.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (K2106679) | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Evaluate resistance to penetration by synthetic blood. | 29 Out of 32 pass at 120 mmHg | Lot 1: 32 Out of 32 pass at 120 mmHgLot 2: 32 Out of 32 pass at 120 mmHgLot 3: 32 Out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Measure initial particulate filtration efficiency using monodispersed aerosols (0.1µm latex spheres). | ≥ 98% | Lot 1: 98.9%Lot 2: 98.9%Lot 3: 98.7% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Determine bacterial filtration efficiency using a biological aerosol of Staphylococcus Aureus. | ≥ 98% | Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9% | Pass |
| Flammability (16 CFR 1610) | Determine flammability characteristics. | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | Pass |
| Differential Pressure (Delta P) (EN 14683:2019) | Measure differential pressure between the inside and outside of the mask. | < 6.0 mmH2O/cm² | Lot 1: 3.0 mmH2O/cm²Lot 2: 3.1 mmH2O/cm²Lot 3: 3.3 mmH2O/cm² | Pass |
| Cytotoxicity (ISO 10993-5) | Determine biological reactivity of mammalian cell culture (mouse fibroblast L929cells). | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Evaluate potential skin irritation from extract on rabbit skin. | Non-irritating | Non-Irritating | Pass |
| Sensitization (ISO 10993-10) | Evaluate potential for extracts to cause skin sensitization in guinea pig. | Non-sensitizing | Non-sensitizing | Pass |
Information Relevant to AI/ML Studies (and why it's mostly absent):
This document describes the regulatory clearance for a physical medical face mask, not an AI/ML powered device. Therefore, information points 2 through 9, which are specifically relevant to the evaluation of AI/ML algorithms, are not applicable and are consequently missing from this submission.
- Sample size used for the test set and data provenance: Not applicable. Performance is evaluated on physical samples/lots of the mask material against defined standards. The data provenance is laboratory testing conducted according to specified ASTM, CFR, EN, and ISO standards. The country of origin of the device manufacturer is China.
- Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for the physical properties of the mask (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory testing methods, not by expert consensus readings of medical images.
- Adjudication method for the test set: Not applicable. Performance is measured objectively through lab tests.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study involves human readers interpreting medical images, optionally with AI assistance. The device is a physical mask.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable. There is no algorithm.
- Type of ground truth used: Ground truth is defined by the objective measurements and pass/fail criteria outlined in the relevant ASTM, CFR, EN, and ISO standards for physical properties and biocompatibility.
- Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided document details the testing and acceptance criteria for a physical medical device (face mask). It successfully demonstrates that the device meets the specified performance criteria through a series of standardized laboratory tests for filtration, fluid resistance, flammability, breathability, and biocompatibility. The framework of questions you've provided is designed for AI/ML devices, hence much of the requested information (e.g., expert readers, adjudication, training data) is not present in this submission.
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