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The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have nose clips design for fitting the face mask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of Polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown cloth. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Elastic materials consisting of Nylon low elastic yarn and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene and galvanized iron wire plastic materials. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The document describes the non-clinical performance testing of a disposable surgical mask to demonstrate its substantial equivalence to a predicate device, rather than a study involving an AI-powered device or human readers. Therefore, much of the requested information regarding AI assistance, human readers, effect size, and ground truth establishment for AI models is not applicable to this document.

However, I can provide information based on the performance testing of the surgical mask.

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

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

• Fluid Resistance Performance (ASTM F1862): 32 samples per lot, tested across three lots (though the table summarizes the results for the current device as "31 out of 32 Pass at 120 mmHg" without specifying if this is across multiple lots for the current device). For the predicate, it states "32 out of 32 pass at 120 mmHg".
• Other performance tests (PFE, BFE, Differential Pressure, Flammability): The exact sample size for these specific tests is not explicitly stated as a number of individual masks, but rather a percentage or single value representing the performance of the device. These are typically performed on a representative sample of the manufactured product.
• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Not explicitly stated, but typically involves a defined number of samples according to ISO standards.
• Data Provenance: The tests were conducted internally by SHANGHAI NO.9 KNITTING MILL CO., LTD., likely in a laboratory setting. The document does not specify the country of origin of the test samples beyond the manufacturing location (Shanghai, China). These are prospective tests on the manufactured product to demonstrate compliance.

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. The "ground truth" here refers to established technical standards (like ASTM, ISO, EN, CFR) for material and product performance, not expert consensus on interpretations of data. The results are objective measurements against these predefined numerical and qualitative criteria.

4. Adjudication method for the test set

This question is not applicable. The test results are objective measurements (e.g., percentages, pressure readings, "pass/fail" based on established criteria) and do not involve human interpretation 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

This is not an AI device. No MRMC study was performed.

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

This is not an AI device. No standalone algorithm performance was assessed.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). The acceptance criteria are derived directly from these technical specifications for medical face masks, specifically for Level 2 performance.

8. The sample size for the training set

This is not an AI device. There is no concept of a "training set" in this context.

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

This is not an AI device. There is no concept of a "training set" or "ground truth establishment for a training set." The "ground truth" for the acceptance criteria for the surgical mask is established by widely recognized and published national and international standards for medical device performance.

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