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The A Plus International, Inc. Solution Face Masks are designed as surgical apparel medical devices that are intended to fully cover the nose and mouth for infection control, and to be worn (for example) by operating room personnel during surgical procedures, so as to protect both the surgical patient as well as operating room personnel from transfer of microorganisms, body fluids, and particulate materials. Solution Face Masks may be used as isolation masks, procedure masks, or dental face masks, but not as combination surgical and respirator masks. Solution Face Masks are intended as single use disposable devices and not intended for reuse of any kind.

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This document is a 510(k) premarket notification acceptance letter for a medical device (face masks). It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Information about standalone algorithm performance studies.
6. The type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

This letter primarily focuses on the FDA's "substantial equivalence" determination to a legally marketed predicate device, indicating that the new device has similar technological characteristics and is safe and effective for its intended use. It does not elaborate on the specific performance studies and their results beyond stating that an equivalence determination has been made based on the submitted information.

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