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510(k) Data Aggregation
(149 days)
The Procedure 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 Procedure face mask is a three-layer, flat-pleated style mask with ear loops and nose piece design for fitting the face mask around the nose and mouth. The proposed device is manufactured with three layers, the inner (Layer #3) and outer (Layer #1) layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of melt-blown polypropylene. The ear loops are made of Polyester & elastane, and the nose piece is made of Malleable polyethylene wire. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. which is made of malleable polyethylene wire. The face masks will be provided in blue. The face masks are sold non-sterile and are intended to be single-use, disposable devices.
This document describes the premarket notification for a procedure face mask (Model: KKF-2A) and its substantial equivalence to a predicate device. The information provided heavily focuses on non-clinical performance testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria for Level 2 | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | 29 out of 32 pass at 120 mmHg | Passed at 120mm Hg | PASS |
| Particulate Filtration Efficiency Performance (%) | ≥ 98% | Passed at 99.8% | PASS |
| Bacterial Filtration Efficiency Performance (%) | ≥ 98% | Passed at 99.8% | PASS |
| Differential Pressure (Delta-P) (mm H2O/cm²) | <6.0 mm H2O/cm² | Passed at 3.8 mmH2O/cm² | PASS |
| Flammability class | Class 1 | Class 1 | PASS |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | PASS |
| Irritation | Non-irritating | Non-irritating | PASS |
| Sensitization | Non-sensitizing | Non-sensitizing | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set for the performance tests beyond the "29 out of 32 pass" for Fluid Resistance Performance. The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. However, tests were conducted to demonstrate that the device is biocompatible and safe.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The testing described is non-clinical performance testing for a face mask, which relies on standardized test methods and criteria rather than expert interpretation of medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. As mentioned above, the evaluation is based on objective performance standards rather than 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
This information is not applicable. This submission is for a medical device (face mask), not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This submission is for a medical device (face mask), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests is based on established industry standards and regulatory requirements (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610 for performance; ISO 10993-1: 2018 for biocompatibility). These standards define objective criteria for mechanical, filtration, and biocompatibility properties.
8. The sample size for the training set
This information is not applicable. This submission is for a medical device (face mask) and does not involve a training set as would be used for machine learning models.
9. How the ground truth for the training set was established
This information is not applicable. This submission is for a medical device (face mask) and does not involve a training set or ground truth establishment in the context of machine learning.
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