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The Humask Pro Vision 3000 mask is single use disposable intended to be worn in the operating room as well as dental, isolation, and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

The Humask Pro Vision 3000 is a clear window surgical mask. A Medical grade face mask with a transparent window.

The provided text is a 510(k) Summary for the Humask Pro Vision 3000, a surgical mask. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/ML-based medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, effect sizes, ground truth establishment) is not present in this document.

However, I can extract information related to the performance data provided for the physical mask itself and present what is available, while clearly indicating what information is not available based on the provided text.

Here's an attempt to answer your request based on the provided document, with many sections marked as "Not Applicable" or "Not Provided" due to the nature of the document.

Understanding the Device: The Humask Pro Vision 3000 is a physical surgical mask, not an AI/ML-based diagnostic or prognostic device. The performance data mentioned pertains to the physical characteristics and safety of the mask itself, such as its filtration efficiency and biocompatibility.

Acceptance Criteria and Reported Device Performance

The document describes performance tests conducted on the Humask Pro Vision 3000 to demonstrate its safety and effectiveness, similar to the predicate device. These tests align with FDA guidance for surgical mask submissions.

Table of Acceptance Criteria and Reported Device Performance (as detailed for a physical mask):

Study Proving Device Meets Acceptance Criteria:

The document states: "The following performance data support the substantial equivalence of the Humask Pro Vision 3000." and "The subject devices met all specified criteria and did not raise new safety or performance questions. Based on the performance testing, the Humask Pro Vision 3000 was found to have a safety and effectiveness profile that is similar to the predicate device."

This indicates that various standardized tests (ASTM, EN, ISO, CFR) were performed on the Humask Pro Vision 3000, and the results demonstrated compliance with the requirements outlined in those standards, thus proving it meets the implied acceptance criteria for a surgical mask of its type.

Regarding AI/ML-specific Study Information (Not applicable to this device, but addressing your prompt structure):

1. Sample size used for the test set and the data provenance: Not applicable. This is a physical mask.

   • Provenance: Not specified for the physical test samples (e.g., number of masks tested for BFE, PFE).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical mask is established by validated laboratory test methods and equipment, not human expert consensus.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the physical mask's performance is established by standardized laboratory testing procedures (e.g., the specific methodologies outlined in ASTM F2101 for BFE, ASTM F2299 for PFE, etc.). These methods are designed to objectively measure the physical properties and performance of the mask.

7. The sample size for the training set: Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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