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510(k) Data Aggregation
(107 days)
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
Surgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.
Surgical Mask is single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are 2 options for the surgical mask to be secured on user - via earloops or ties. Earloops are of urethane elastic fiber and latex-free; and ties are of spunbond polypropylene and also latex-free. The nose piece is a pliable white aluminum strip, covered by PP covering. All of the materials used in the construction of the Surgical Mask are being used in currently marketed devices.
This is a medical device, not an AI/ML device. The provided text is a 510(k) Summary for a surgical mask, which is a physical product, not a software algorithm. Therefore, the questions regarding acceptance criteria and studies for an AI/ML device are not applicable.
The document discusses the substantial equivalence of the surgical mask to a predicate device based on material, intended use, mask style, design features, and performance test results against established consensus standards (e.g., ASTM, MIL-M, ISO).
Here's a breakdown of the relevant information provided for the surgical mask:
Acceptance Criteria and Device Performance (Surgical Mask)
The acceptance criteria for the surgical mask are implicitly defined by the performance characteristics of the predicate device (K061716) and relevant consensus standards. The study demonstrates that the device "meets" these criteria by showing its performance is similar to or better than the predicate device.
| Description | Acceptance Criteria (from Predicate Device K061716 or Implied Standard) | Reported Device Performance (Surgical Mask) |
|---|---|---|
| Fluid resistance (ASTM 1862) | Fluid resistant | Fluid resistant |
| PFE (ASTM F2299) | 98.5% at 0.1 micron | Average 99.54% at 0.1 micron |
| BFE (ASTM F2101) | 99.6% | >99.9% |
| Flammability Class (16CFR 1610) | 1 | 1 |
| Delta-P (MIL-M-36945C 4.4.1.1.1) | 2.6 mmH2O/cm² | Average 3.38 mmH2O/cm² |
| Biocompatibility (ISO 10993-5, -10) | Pass (No cytotoxicity, sensitization, irritation) | No cytotoxicity, No sensitization, No irritation |
Irrelevant/Not Applicable Information for AI/ML Device Study:
The following questions are not applicable to this 510(k) submission for a surgical mask:
- Sample sized used for the test set and the data provenance: Not applicable. Performance tests for physical masks follow specific standard protocols, not "test sets" in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical mask performance is based on standardized physical and chemical tests, not expert consensus on data interpretation.
- 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.
- 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): Ground truth for a surgical mask's performance is based on physical and chemical testing according to recognized standards (e.g., ASTM, ISO).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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