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The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user. The proposed device can be provided in sterile and non-sterile two types.

The document you provided is a 510(k) Premarket Notification for Surgical Face Masks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or standalone study.

Therefore, the information requested in your prompt (acceptance criteria, details of a study proving device performance, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document. This 510(k) primarily relies on non-clinical performance testing and a comparison of technological characteristics to a predicate device.

Specifically:

• No clinical study was conducted or included in this submission. The document explicitly states this in Section 7: "No clinical study is included in this submission."
• The "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device performs "as well as" or "better than" the predicate device in relevant non-clinical tests or by meeting recognized consensus standards. The document shows tables of test results (e.g., Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Fluid Resistance) against, or in comparison to, the predicate device and relevant standards (e.g., ASTM F2100 Level 2).
• There is no mention of human experts establishing ground truth for a test set, adjudication methods, or MRMC studies because there was no clinical study.

However, I can extract information related to the device performance and testing that was done to support the 510(k) clearance, framed as "reported device performance" against relevant "acceptance criteria" derived from the standards and predicate comparison:

The provided 510(k) Premarket Notification for Surgical Face Masks (K202843) demonstrates substantial equivalence to a predicate device (K173062) by relying on non-clinical performance testing rather than a clinical study. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of human data, expert adjudication, or MRMC studies is not applicable to this submission.

Instead, the device meets "acceptance criteria" by demonstrating performance in laboratory tests in accordance with recognized consensus standards (e.g., ASTM F2100 Level 2) and by showing that its technological characteristics are substantially equivalent to the predicate device.

Here's an interpretation of the requested information based on the provided document, focusing on the non-clinical testing performed:

1. Table of Acceptance Criteria (as per standards/predicate comparison) and Reported Device Performance:

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Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.

The proposed devices are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.

This document is a 510(k) Summary for a Surgical Gown (Sterile) and Surgical Gown (Non-sterile). It describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence.

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 document provides a "Technological Characteristic Comparison Table" (Table 2) that lists various performance criteria and the performance of the Subject Device (K202706). It implies that the acceptance criteria are met if the device's performance is similar to or meets the standards of the predicate devices or specified test methods.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each non-clinical test or the provenance of the data (e.g., country of origin, retrospective/prospective). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The study involved non-clinical performance testing of a medical device (surgical gown), not studies requiring expert interpretation or ground truth establishment in a medical context.

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

This section is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment.

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 section is not applicable. No clinical studies, MRMC studies, or AI components are mentioned in this 510(k) summary.

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

This section is not applicable. The device is a surgical gown; it does not involve an algorithm or AI.

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

The "ground truth" for the non-clinical tests were established by the performance specifications outlined in recognized standards such as ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127:2017, AATCC 42:2017, ISO 9073-10:2003, ASTM D1683/D1683M:2017/(R)2018, ASTM D5587:2019, ASTM D5034:2017, ASTM D737:2018, ASTM F88/F88M:2015, ASTM F1929:2015, ISO 10993-7:2008, ISO 10993-5:2009, and ISO 10993-10:2010.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is a non-clinical device performance study, not a machine learning or AI-based study.

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

This section is not applicable. As there is no training set for this type of device submission.

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