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510(k) Data Aggregation
(197 days)
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.
The document provided relates to a 510(k) premarket notification for a Biodegradable Medical surgical mask (K231155) and is primarily focused on demonstrating substantial equivalence to a predicate device (K201622) through non-clinical performance testing. It does not contain information about the performance of an AI/ML powered device, nor does it describe a study involving human readers or expert ground truth adjudication in the context of diagnostic accuracy.
Therefore, the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models is not applicable to this document.
The document reports on standard non-clinical performance tests for medical masks. Here is a table summarizing the acceptance criteria and results for these tests:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥95% | Pass |
| Differential Pressure (mmH2O/cm²) (EN14683:2019 Annex C) | Determine breathability of the mask | <5.0 mmH2O/cm² | Pass |
| Sub-micron Particulate Filtration Efficiency (ASTM F2299-17) | Measure initial particle filtration efficiency | ≥95% | Pass |
| Resistance to Penetration by Synthetic Blood (ASTM F1862-17) | Evaluate the resistance to penetration by impact of small volume of synthetic blood | 29 out of 32 pass at 80 mmHg | Pass |
| Flammability (16 CFR Part 1610-2008) | Response of materials to heat and flame | Class 1 | Pass |
| In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass |
| Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass |
| Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass |
The "Pass" result indicates that the device met the specified acceptance criteria for each test.
The following information is not present in the provided document, as it pertains to AI/ML device studies, which this medical mask submission is not:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
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