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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Non-sterile surgical face mask, white, yellow, pink, blue and green.

Here's a breakdown of the acceptance criteria and study information based on the provided documents:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a 510(k) Premarket Notification for a surgical face mask (K022256). This type of submission in the US regulatory framework for medical devices does not involve clinical trials or studies like those typically conducted for AI/software devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, many of the requested details, such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this type of device and submission.

Here's what can be inferred or explicitly stated based on the provided text:

• Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the face mask undergoing standardized laboratory tests. The data provenance is from tests conducted on samples of the manufactured device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical performance tests is established by the standardized test methods themselves and measured by laboratory equipment, not by human experts.
• Adjudication method for the test set: Not applicable. Results are quantitative or visually assessed according to the standard.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a diagnostic device involving human interpretation of cases.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable. This is a physical device, not an algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is defined by the objective measurements and criteria within the specified ASTM and MIL standards. For example, "no visual detection of penetration" is a direct observational outcome of the ASTM F-1862-00a fluid resistance test.
• The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device testing in this context.
• How the ground truth for the training set was established: Not applicable.

Summary of the "study" for this device:

The "study" involved performing a series of standardized laboratory tests on the surgical face mask (K022256) and comparing its performance characteristics to both pre-defined acceptance criteria (where available) and the performance of a legally marketed predicate device (K970835). The goal was to demonstrate that the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, based on its physical performance.

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