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510(k) Data Aggregation
(198 days)
Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.
The provided document is a 510(k) Premarket Notification for a Medical Mask (Model: KKF-1A). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than an AI-powered medical device.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for AI test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a traditional medical device (a mask) and standard testing for physical properties and biological safety.
However, I can extract the acceptance criteria and performance data for the medical mask based on the provided tables.
Acceptance Criteria and Reported Device Performance for the Medical Mask (Model: KKF-1A)
| Item (Performance Test) | Acceptance Criteria for Level 1 (ASTM F2100-19) | Reported Device Performance (Test Results) |
|---|---|---|
| Fluid Resistance Performance (mmHg) ASTM F1862 | 29 out of 32 pass at 80 mmHg | Passed at 80 mmHg |
| Particulate Filtration Efficiency Performance (%) ASTM F2299 | ≥ 95% | Passed at 99.3% |
| Bacterial Filtration Efficiency Performance (%) ASTM F2101 | ≥ 95% | Passed at 98.1% |
| Differential Pressure (Delta-P) (mm H2O/cm²) MIL-M-36954C | < 5.0 mm H2O/cm² | Passed at 4.8 mm H2O/cm² |
| Flammability class Class 1 (16 CFR 1610) | Class 1 | Class 1 |
Biocompatibility Testing Summary (based on ISO 10993-1: 2018)
| Test Item | Acceptance Criteria (Implied: Non-cytotoxic, Non-irritating, Non-sensitizing) | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | PASS (non-cytotoxic) |
| Irritation | Non-irritating | PASS (non-irritating) |
| Sensitization | Non-sensitizing | PASS (non-sensitizing) |
Since this document pertains to a physical medical mask rather than an AI/ML device, the following points are not present or not applicable in the provided text:
- Sample sized used for the test set and the data provenance: Not applicable. These are physical tests on the mask material, not an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as ground truth is established via standardized physical and chemical tests, not expert consensus on medical images or outcomes.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI-assisted diagnostic devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth here is the results of standardized physical and chemical tests as per ASTM, EN, and ISO standards (e.g., specific filtration percentages, pressure values, and biological reaction classifications).
- 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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