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510(k) Data Aggregation
(96 days)
The Disposable Medical Face Mask is 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.
Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-powered medical device. Therefore, most of the requested information about an AI-powered device, such as MRMC studies, training set details, or expert ground truth establishment, is not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical properties of the face mask as tested.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Proposed Device (Reported Performance) | Acceptance Criteria | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 32 out of 32 pass at 160 mmHg (across 3 lots) | 29 out of 32 pass at 160 mmHg for level 3 | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | Lot1: 98.9%, Lot2: 99.3%, Lot3: 99.5 % | ≥ 98% | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | Lot1: 99.88%, Lot2: 99.95%, Lot3: 99.97% | ≥ 98% | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask | Lot1: 3.3 H2O/cm², Lot2: 3.4 H2O/cm², Lot3: 3.3 H₂O/cm² | < 6.0mmH₂O/cm² | PASS |
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-cytotoxic | Non-Cytotoxic | PASS |
| Irritation | Assess the potential risk of Irritation of mask material | Non-irritating | Non-Irritating | PASS |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-sensitizing | Non-Sensitizing | PASS |
2. Sample size used for the test set and the data provenance:
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Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure:
- Sample Size: 3 non-consecutive lots were tested. For each lot, a sample size of 32 was used for each test. (e.g., 32 samples for fluid resistance from Lot1, 32 from Lot2, 32 from Lot3).
- Data Provenance: Not explicitly stated as retrospective or prospective, but these are standard laboratory tests on manufactured lots. The manufacturer is Xiantao Zhibo Nonwoven Products Co., Ltd. in Hubei, China, so the testing would likely have occurred in China or at a contract lab.
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Biocompatibility (Cytotoxicity, Irritation, Sensitization):
- Sample Size: Not explicitly stated as a number of devices/samples, but the tests were performed on "mask material" based on ISO10993 standards.
- Data Provenance: Not specified, but likely conducted by the manufacturer or a contracted lab to meet ISO 10993 requirements.
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 as the document describes physical performance testing of a medical face mask, not an AI device that requires expert-established ground truth for image/data interpretation. The ground truth for these tests is based on the results of standardized laboratory measurements and physical/chemical properties.
4. Adjudication method for the test set:
This is not applicable. The tests performed are objective laboratory measurements, not interpretations 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:
This is not applicable. This document is about a physical medical device (face mask), not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This document is about a physical medical device (face mask), not an AI-powered algorithm.
7. The type of ground truth used:
The ground truth for these tests is based on objective laboratory measurements and established physical/chemical standards for material performance (e.g., precise measurements of filtration efficiency, pressure differential, and biological assays for cytotoxicity/irritation/sensitization). There is no "expert consensus" in the sense of radiological or pathological interpretations.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is a physical device, not an AI model.
9. How the ground truth for the training set was established:
This is not applicable. There is no "training set" or corresponding ground truth establishment for this type of device.
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