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510(k) Data Aggregation
(50 days)
The banded face 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.
Banded Face Mask
This is a 510(k) clearance letter for a Banded Face Mask, which is a physical device, not an AI or software-as-a-medical-device (SaMD). Therefore, the typical acceptance criteria and study designs applicable to AI devices (such as those involving performance metrics like sensitivity, specificity, AUC, and human-in-the-loop studies) are not relevant here.
The document focuses on substantial equivalence to predicate devices for regulatory clearance, based on the physical properties and intended use of the face mask. It does not contain information about the performance criteria you've asked for in the context of an AI device.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device based on this document.
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(71 days)
The 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. 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.
The Medical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The Medical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' 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 layers of facemask is to allow the user to fit the facemask around their nose, which is made of Malleable polyethylene wire.
The medical face masks are available in five sizes, 17.59.5cm, 15.59.5cm, 14.59.5cm, 149.5cm.
The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided text is related to the FDA 510(k) clearance for a Medical Face Mask. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than focusing on AI/ML-driven device performance. Therefore, many of the requested elements for describing an AI-powered device's acceptance criteria and study cannot be directly extracted from this document, as they are not applicable to the type of device (medical face mask) being discussed.
However, I can extract the acceptance criteria and performance data relevant to this medical face mask:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Demonstrate functionality | 29 out of 32 per lot pass at 80 mmHg | Pass (32 out of 32 pass at 80 mmHg, 3 lots) |
| Particulate Filtration Efficiency (ASTM F2299) | Demonstrate functionality | $\ge$ 95% | Pass (> 95%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Demonstrate functionality | $\ge$ 95% | Pass (> 99%) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Demonstrate functionality | < 5.0 mmH₂O/cm² | Pass (< 4.0 mmH₂O/cm²) |
| Flammability (16 CFR 1610) | Demonstrate functionality | Class 1 | Pass (Class 1) |
| Cytotoxicity (ISO 10993-5) | Demonstrate safety | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Demonstrate safety | Non-irritating | Non-irritating |
| Sensitization (ISO 10993-10) | Demonstrate safety | Non-sensitizing | Non-sensitizing |
Since this is a submission for a medical face mask and not an AI/ML device, the following points are not applicable or cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: The document mentions "3 non-consecutive lots" for fluid resistance testing but doesn't specify an overall sample size for the various performance tests. Data provenance in terms of country of origin or retrospective/prospective is not specified as these are material performance tests, not clinical data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a face mask is established by validated laboratory testing against standards, not by expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for expert review of complex data, not physical product testing.
- 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. This is a medical device (face mask), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is established through adherence to recognized international and national standards for medical face masks, such as ASTM F2100, ASTM F1862, ASTM F2101, EN 14683, 16 CFR 1610, and ISO 10993 for biocompatibility.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
- How the ground truth for the training set was established: Not applicable.
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