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The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device based on bench testing (non-clinical testing) rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the requested points related to AI, MRMC studies, expert ground truth adjudication, and clinical trial specifics are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document explicitly mentions "0/125 / Pass" for the ASTM D5151 Watertightness Test, indicating a sample size of 125 for this test. For other "Pass" results, the exact sample sizes are not explicitly stated, but the tests are typically performed on a statistically relevant number of samples to demonstrate compliance with the ASTM/ISO standards.
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer. The company is Anhui Bytech Medical Supplies Co., Ltd., located in Anhui Province, China. The data is from the manufacturer's internal testing as part of their premarket notification. The document indicates these are "non-clinical tests."

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

• Not Applicable. This is a medical device 510(k) submission for examination gloves, which are low-risk devices. The "ground truth" for proving the device meets acceptance criteria comes from standardized laboratory bench testing (e.g., measuring physical properties, mechanical strength, and biocompatibility), not from expert interpretation of medical images or clinical outcomes. Therefore, no medical experts were involved in establishing "ground truth" for the performance tests.

4. Adjudication Method for the Test Set

• Not Applicable. As the "ground truth" is established via objective physical and chemical measurements (bench testing) according to international standards (ASTM, ISO), there is no need for expert adjudication. The results are quantitative and directly compared to pre-defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

• Not Applicable. This device is an examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are relevant for evaluating the impact of AI on human readers' performance in tasks like image interpretation, which is not pertinent to this device.

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

• Not Applicable. There is no AI algorithm involved with this device; it is a physical product (gloves).

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective, quantitative measurements from standardized laboratory tests according to recognized international consensus standards (ASTM and ISO). Examples include:
  • Direct measurement of dimensions (length, width, thickness).
  • Quantification of tensile strength and ultimate elongation.
  • Detection of holes using a water integrity test.
  • Measurement of residual powder content.
  • Biological performance testing (cytotoxicity, irritation, sensitization) in vitro, which involves observing cellular responses under controlled lab conditions.

8. The Sample Size for the Training Set

• Not Applicable. This submission is for a physical medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process itself involves quality control and process validation, which might involve sample testing, but this is distinct from "training data" for an algorithm.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided document.

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