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510(k) Data Aggregation
(96 days)
The Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face 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(s) provided non-sterile. It is intended for adults only (greater than 21 years of age).
The Disposable Medical Mask is a blue, flat pleated type mask, which utilizes an Earloop to Wear. It has a nose piece design to fit the facemask around the nose. The Disposable Medical Masks are manufactured with three layers and the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt-blown polypropylene filter. The model of the proposed device, earloop, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the mask is in the facemask layers to allow the user to fit the facemask around their nose, made of malleable aluminum wire. The Disposable Medical Masks are sold non-sterile and are intended to be a single-use, disposable device.
The provided document is a 510(k) summary for a disposable medical mask. It details the device's technical characteristics and performance testing against established standards, primarily for determining substantial equivalence to a predicate device.
Here's the information requested based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is seeking to meet Level 2 classification according to ASTM F2100-19.
| Test | Standards | Acceptance Criteria for Level 2 Mask | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE, %) | ASTM F2101 | ≥ 98 | Average 99.54% (Pass) |
| Particulate Filtration Efficiency (PFE, at 0.1 µm, %) | ASTM F2299 | ≥ 98 | Average 99.37% (Pass) |
| Differential Pressure (Delta P, mm H2O/cm²) | ASTM F2100-19 EN 14683:2019, Annex C | < 6.0 | 4.00 mm H2O/cm² (Pass) |
| Resistance to penetration by synthetic blood (minimum pressure in mmHg for pass result) | ASTM F1862/F1862M-17 | ≥ 120 mmHg | 32 out of 32 pass at 120mmHg (Pass) |
| Flame Spread | 16 CFR 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable (Pass) |
| In Vitro Cytotoxicity | ISO10993-5: 2009 | Non-cytotoxic | Non-cytotoxic (Pass) |
| Skin Sensitization | ISO10993-10: 2010 | Non-sensitizing | Non-sensitizing (Pass) |
| Skin Irritation | ISO10993-10 | Non-irritating | Non-irritating (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 sizes for each specific performance test (e.g., the number of masks tested for BFE or PFE). For the Fluid Resistance test, it is stated that "32 out of 32 pass at 120mmHg," implying a sample size of 32 for that specific test.
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that the device manufacturer is in China: "TUOSHENG PROTECTIVE PRODUCTS (NINGBO) CO.,LTD... Zhejiang Province, CHINA".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluations are based on objective, standardized laboratory tests (e.g., ASTM, ISO standards) for material performance and biocompatibility, not on expert interpretation of medical images or clinical data. There is no concept of "ground truth" established by experts in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation is based on objective laboratory testing against pre-defined numerical and qualitative criteria, not on subjective assessments requiring 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
No such study was performed or is relevant to this device. This document describes the testing of a medical mask, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by the objective, quantitative performance specifications outlined in the referenced international consensus standards (ASTM, EN, ISO, 16 CFR). For example, a BFE of ≥98% is the objective standard (ground truth) for a Level 2 mask in that particular test.
8. The sample size for the training set
This information is not applicable. The device is a physical medical mask. There is no "training set" as it is not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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