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The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.

Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum wire. All the materials used in the construction of the Modern Healthcare Corp. Surgical Face Mask are being used in currently marked devices.

The provided text is a 510(k) summary for a surgical face mask. It indicates that no clinical tests were performed to establish acceptance criteria or to prove that the device meets those criteria. Instead, the device's substantial equivalence to a predicate device (K060776) was demonstrated through bench testing.

Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's a breakdown of what can be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not applicable. The document states "Discussion of Clinical Tests Performed: Not Applicable". Performance targets and results from clinical studies are not provided. The substantial equivalence is based on meeting the same technological characteristics as the predicate device, which implies compliance with relevant standards through bench testing, not clinical performance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set or data provenance is mentioned. The submission relies on "bench testing" which is typically laboratory-based and doesn't involve human subjects for performance evaluation in the way a clinical study would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set requiring expert ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication is mentioned.

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

Not applicable. This is a surgical face mask, not an AI-assisted diagnostic device. No MRMC study or AI component is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a surgical face mask, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth is mentioned. The evaluation is based on bench testing of the product's physical and filtration properties, comparing them to established standards and the predicate device.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth for a training set is mentioned.

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