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Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile

The Dong Hai Xiang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (polypropylene), Inner layer (polypropylene), Middle Layer filter (Polypropylene Melt-blown), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Dong Hai Xiang Surgical Masks are single use, adult only, disposable device, provided non-sterile.

This document is a 510(k) Summary for the Dong Hai Xiang Surgical Mask, outlining its safety and effectiveness compared to a predicate device. It details performance criteria typical for surgical masks rather than a complex AI-driven medical device. Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable here.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: Dong Hai Xiang Surgical Mask
Type: Surgical Apparel (Class II Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For performance tests, 96 samples were used, consisting of 32 samples from each of 3 non-consecutive lots. For biocompatibility tests, the sample sizes are implicitly standard for the ISO tests cited, but specific numbers of samples or subjects are not detailed beyond the qualitative result statements.
• Data Provenance: The document does not specify the country of origin for the testing data. The testing was described as "nonclinical tests" (bench tests and biocompatibility evaluations) rather than clinical trials with human subjects. The data is retrospective in the sense that these are laboratory test results submitted to the FDA.

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

This is not applicable as the studies are non-clinical, objective performance tests (e.g., filtration efficiency, fluid resistance) conducted in a laboratory setting according to specified ASTM/EN/ISO standards. Ground truth is established by the results of these standardized physical and biological tests, not by expert interpretation of complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements or qualitative assessments (e.g., "Pass/Fail," "Non-cytotoxic") based on established laboratory protocols and thresholds, not subjective interpretations requiring adjudication.

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

No, an MRMC study was not done. This type of study is typically performed for imaging or diagnostic AI devices where multiple human readers interpret cases, with and without AI assistance, to assess the AI's impact on diagnostic accuracy and efficiency. This document concerns a physical medical device (surgical mask) that does not involve human interpretation or AI assistance in its direct use.

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

This concept is not applicable. The device is a physical product (surgical mask), not an algorithm or AI. The tests performed assess the physical properties and biological safety of the mask itself.

7. The Type of Ground Truth Used

The "ground truth" for the test set is established by:

• Standardized Bench Test Procedures: Adherence to and results from specific international standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610) for evaluating the physical performance characteristics of surgical masks.
• Biocompatibility Standards: Results demonstrating compliance with ISO 10993 series standards for biocompatibility (cytotoxicity, irritation, sensitization).

These are objective, laboratory-based "ground truths" based on scientific measurements, not subjective human interpretations.

8. The Sample Size for the Training Set

Not applicable. This device is a manufactured product, not an AI/ML algorithm that requires a 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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