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The Surgical Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of micro-organisms, body fluids and particulate material.

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The provided document is a 510(k) premarket notification letter from the FDA for a face mask, not a device that utilizes AI or requires a study to prove its performance based on the provided criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of the Act."

This means the face mask was cleared based on substantial equivalence to an existing legally marketed device, not on a new study demonstrating its performance against specific acceptance criteria in the way you've outlined for AI-powered devices.

Therefore, I cannot provide the information requested in your prompt because the document does not contain details about:

1. Acceptance criteria and reported device performance: This face mask was cleared through substantial equivalence, not by meeting specific performance metrics from a new study.
2. Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set size, or how ground truth was established: These are all relevant to clinical studies for new or AI-powered devices, which is not the context of this 510(k) clearance for a face mask.

The document only discusses the regulatory process for a physical device (a face mask) and its clearance based on substantial equivalence.

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