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Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

The TIDI® Facemask are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of 100% SBPP. The nosepieces are made of aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The face mask covers the nose and mouth, and is secured to the face using ear loops.

This document describes the TIDI® Facemask and its non-clinical performance data to demonstrate substantial equivalence to predicate devices, as part of a 510(k) submission (K100800). The information provided is for a medical face mask, and thus the acceptance criteria and performance data are related to material performance rather than clinical diagnostic accuracy or reader studies.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The device performance is benchmarked against the requirements of ASTM F-2100-07, "Standard Specification for performance of Materials Used in Medical Face Masks." The document states that the TIDI® Facemask "meet the requirements" of this standard.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for BFE, or number of synthetic blood penetration tests). The data provenance is non-clinical laboratory testing performed to established ASTM standards. The country of origin of the data is not specified beyond the fact that it's for a US FDA submission, suggesting the testing was likely conducted in a regulated environment in line with US standards. The data is retrospective in the sense that it was collected before the submission of the 510(k).

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 in the context of this document. The "ground truth" for the performance of a medical face mask is established by validated standardized testing methods (ASTM standards) rather than expert consensus on diagnostic images or clinical outcomes. The tests themselves are designed to objectively measure material properties.

4. Adjudication method for the test set

Not applicable. As described above, the evaluation relies on objective, standardized laboratory test results, not on subjective interpretations requiring adjudication.

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

Not applicable. This document is for a medical face mask, which is a physical device, not an AI software or diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. This is not an AI algorithm but a physical medical device.

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

The "ground truth" for the TIDI® Facemask's compliance is the results obtained from standardized laboratory tests performed according to the specified ASTM standards. These standards define objective pass/fail criteria for material performance.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for a physical device.

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Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

The TIDI® Facemask, are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% SBPP or 100% medical grade tissue paper. The ear loops are made of latex free elastic. The nosepieces are made of malleable aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The mask covers the nose and mouth, and is secured to the face using the attached ear loops. The TIDI® Facemasks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body fluids and particulate material.

The document provided describes the TIDI® Facemask, a surgical mask, and its nonclinical testing to demonstrate substantial equivalence to predicate devices, rather than a novel AI/software medical device. As such, most of the requested information regarding AI device evaluation (e.g., sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training data) is not applicable to this submission.

However, I can extract the acceptance criteria and performance data for the TIDI® Facemask as presented in the document.

Acceptance Criteria and Reported Device Performance

The study referenced is a nonclinical test performed to demonstrate that the TIDI® Facemask meets the specified acceptance criteria of ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Mask. This standard defines requirements for different performance classes (Low Barrier, Moderate Barrier, High Barrier). The TIDI® Facemask was tested against these criteria.

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