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The Disposable Surgical Face Masks are intended to be worn to protect both the patient 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 fluids. This is a single-use, disposable device, provided non-sterile.

Disposable Surgical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (Spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with plastic covering) to provide a firm fit over the nose.

This document is a 510(k) summary for a Disposable Surgical Face Mask. To provide a comprehensive answer regarding acceptance criteria and study proving device meets them, I will focus on the non-clinical performance tests which are detailed for this device. This document does not describe a clinical study or an AI/human-in-the-loop system.

Here's a breakdown based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various ASTM standards (F2100, F1862, F2299, F2101) and others (MIL-M-36954C, 16 CFR Part 1610, ISO 10993 series). The device performance is compared to these standards across different performance levels (Level 1, Level 2, Level 3).

Note: The table above extracts the relevant quantitative and qualitative performance data. "Same" implies performance is within acceptable limits relative to the predicate or standard. "Better" implies the subject device shows a numerically superior result where higher numbers are better (e.g., higher PFE/BFE) or lower numbers are better (e.g., lower Delta P, indicating better breathability).

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of masks, test replicates) used for each non-clinical performance test. It states "Non-clinical tests were conducted..." without providing the number of units tested.
• Data Provenance: The tests are non-clinical (laboratory) rather than patient data. The manufacturer is Jiangsu New Value Medical Products Co., Ltd. in China, implying the tests were likely conducted in China or by labs contracted by the manufacturer. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This evaluation is based on non-clinical, objective laboratory testing against established performance standards (ASTM, MIL-M, ISO, CFR). Therefore, there isn't a concept of a "ground truth established by experts" in the traditional sense of medical image interpretation or clinical outcomes. The "ground truth" is defined by the passing criteria of the referenced standards.
• The qualifications of the laboratory personnel performing these tests are not explicitly stated in this document, but they would be expected to be trained and qualified in laboratory testing and quality control for medical devices.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this is objective laboratory testing against defined standards, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document explicitly states in "Clinical Test Conclusion": "No clinical study is included in this submission."
• Therefore, an MRMC comparative effectiveness study was not performed, and there is no information on how human readers would improve with AI assistance, as AI is not part of this device.

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

• No. This is a physical medical device (surgical face mask), not an AI algorithm. Therefore, the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on objective, standardized laboratory test measurements that meet pre-defined performance criteria outlined in recognized consensus standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR Part 1610, ISO 10993 series). The comparison is also made against a legally marketed predicate device (K160269) for which similar data would have been accepted.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device.

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