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Sheng Jing Tang 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 Sheng Jing Tang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (Spun-bond polypropylene), Inner layer (Spun-bond polypropylene), Middle Layer filter (Polypropylene Melt-blown Cloth), 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 Sheng Jing Tang Surgical Masks are single use, disposable device, adult only, provided non-sterile.

This document describes the premarket notification (510(k)) for the Sheng Jing Tang Surgical Mask. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance and biocompatibility testing conducted to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is primarily found in Section 7.1 "Performance Test" and Section 7.2 "Biocompatibility Evaluation and Test" of the 510(k) Summary.

Performance Test (Bench Tests)

Biocompatibility Evaluation and Test

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

• Sample Size for performance tests: For each performance test, 96 samples were used (32 samples from each of 3 non-consecutive lots).
• Sample Size for biocompatibility tests: Not explicitly stated but standard ISO 10993 tests are referenced, implying appropriate sample sizes were used for those specific tests.
• Data Provenance: The tests were non-clinical bench and biocompatibility tests, not human subject data. The company, Liaoning Shengjingtang Biotechnology Co., Ltd., is located in China. The document does not specify the country of origin for the testing labs but implies they were conducted to international standards (ASTM, EN, ISO). These were presumably prospective tests conducted on the manufactured device.

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

N/A. This is a medical device (surgical mask), and the "ground truth" for its performance and safety is established through standardized laboratory tests against predefined performance parameters (e.g., filtration efficiency, fluid resistance), not through expert consensus on medical images or diagnoses. The "experts" are the testing laboratories and their qualified personnel who conduct the tests according to the specified standards.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus "ground truth." For bench and biocompatibility testing of a physical device, the results are quantitative or qualitative assessments based on defined test methods and equipment, not subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. This document pertains to a physical medical device (surgical mask) and its performance against standard criteria.

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

Yes, the studies described are analogous to "standalone" performance for a physical device. The device's performance characteristics (filtration, fluid resistance, etc.) were measured directly, without human intervention in the performance of the mask itself.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is defined by international and national standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 series). The device's performance is measured against the criteria established within these standards to ensure it meets the necessary safety and effectiveness requirements for its intended use. This is a form of objective performance data derived from standardized laboratory testing.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a "training set" of data. The device is a physical product (surgical mask), and its development and manufacturing processes are iterative but do not involve machine learning training data.

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

N/A. As this is not an AI/ML device, the concept of a "training set" and establishing ground truth for it does not apply. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and the relevant performance and safety standards.

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