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The Impertech Surgical Face Mask are intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.

The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile.

The provided text describes the acceptance criteria and the study conducted for the Impertech Surgical Face Mask to demonstrate its substantial equivalence to a predicate device. This is a 510(k) submission for a medical device (a surgical mask), not an AI/ML-enabled device. Therefore, many of the requested details, such as human reader studies, AI training data, and ground truth establishment for AI models, are not applicable to this document as it does not concern an AI system.

The study proves the device meets the acceptance criteria through non-clinical performance testing based on recognized standards for surgical masks.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming to be an ASTM F2100 Level 3 Surgical Face Mask. The acceptance criteria are defined by the ASTM F2100 standard for Level 3, and the reported performance indicates that the Impertech Surgical Face Mask passes these criteria.

Biocompatibility Acceptance Criteria and Performance:

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each of the performance tests (e.g., how many masks were tested for BFE or PFE). However, the tests are conducted in accordance with the relevant ASTM and EN standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) and ISO standard for biocompatibility (ISO 10993). These standards typically define minimum sample sizes for testing to ensure statistical validity.

• Data Provenance: The origin of the data (e.g., country) is not explicitly stated for the testing labs, but the manufacturer is Impertech Industries Ltd. located in Barkan, IL (presumably Israel, given the phone number starting with +972). The testing is non-clinical performance testing, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this is not an AI/ML device or a diagnostic study requiring human expert interpretation for ground truth. The "ground truth" for a surgical mask is established by its physical performance against a set of objective, measurable engineering and material standards (ASTM F2100, ISO 10993 tests).

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

This is not applicable as there is no human interpretation or subjective assessment involved that would require an adjudication method. The testing results are quantitative and objective measurements performed by laboratories.

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

This is not applicable. This is a physical device (surgical mask), not an AI-enabled diagnostic tool that would involve human readers or AI assistance.

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

This is not applicable. There is no algorithm or software component for this device.

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

The "ground truth" for this device is based on objective, quantitative measurements against established medical device performance standards (ASTM F2100 for filtration efficiency, differential pressure, fluid resistance, flammability; and ISO 10993 for biocompatibility) conducted in laboratories. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device, so there is no "training set."

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

This is not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the document demonstrates that the Impertech Surgical Face Mask meets the performance requirements for an ASTM F2100 Level 3 Surgical Face Mask through a series of standard physical and biological tests. The context is a 510(k) submission for a non-AI medical device, which explains why many of the questions regarding AI/ML study design are not relevant.

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