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510(k) Data Aggregation
(294 days)
The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.
Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
This document is a 510(k) summary for a Disposable Medical Mask (Model: k0450). It focuses on demonstrating substantial equivalence to a predicate device. The information provided is for a medical device (surgical mask), not a software or AI device. Therefore, the concepts of human readers, AI assistance, effect size, training sets, and ground truth establishment in the context of AI/ML models are not applicable to this document.
The acceptance criteria and performance data pertain to the physical characteristics and barrier performance of the surgical mask.
1. Table of acceptance criteria and the reported device performance
| Test Purpose | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F1862 | ≥ 29 Out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg |
| Particulate Filtration Efficiency Performance (%) | ASTM F2299 | ≥ 98% | 99.9% |
| Bacterial Filtration Efficiency Performance (%) | ASTM F2101 | ≥ 98% | 99.9% |
| Flammability class | 16 CFR 1610 | Class 1 | Class 1 |
| Differential Pressure (Delta-P) (mm H2O/cm2) | ASTM F2100-19 | < 5.0 mmH2O/cm2 | < 5.0 mmH2O/cm2 |
2. Sample size used for the test set and the data provenance
- Fluid Resistance Performance (ASTM F1862): The test involved 32 samples as indicated by the acceptance criteria and reported performance ("29 Out of 32 pass" and "32 out of 32 pass").
- Other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Flammability, Differential Pressure): The sample sizes for these specific tests are not explicitly stated in the provided text, beyond the percentage or class reported.
- Data Provenance: The tests were conducted by a lab (implied by "lab bench testing") to evaluate the safety and effectiveness of the device. The specific country of origin of the testing lab is not mentioned, though the manufacturer is based in China. The tests are described as "non-clinical tests" and not related to human subject data, therefore, "retrospective or prospective" doesn't apply in the context of clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical medical device (surgical mask) evaluated by laboratory bench testing against established performance standards. "Experts" to establish a ground truth in the sense of clinical interpretation or diagnosis are not relevant for this type of testing. The "ground truth" is defined by the objective measurement standards referenced (e.g., ASTM F1862, ASTM F2101).
4. Adjudication method for the test set
N/A. As this involves objective physical testing against defined standards, an adjudication method for reconciling expert opinions is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
N/A. An MRMC study is relevant for comparing the performance of readers (e.g., clinicians) with and without assistance from a diagnostic tool or AI. This submission is for a physical medical device (surgical mask) and does not involve human readers in its performance evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not a software or algorithm-based medical device.
7. The type of ground truth used
The "ground truth" for the performance of the Disposable Medical Mask is based on objective measurements against established performance standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for bacterial filtration efficiency, 16 CFR 1610 for flammability). These standards define the criteria for a "Level 2 barrier" mask.
8. The sample size for the training set
N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
N/A. This is not an AI/ML device that requires a training set or ground truth established for it.
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