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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The proposed devices, Powder-free Vinyl Exam Gloves are non-sterile, clear, noncolored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

The provided text describes a 510(k) premarket notification for "Clear Vinyl Powder-free Patient Examination Gloves" (K171317) by Shandong Zhi Hong Medical Products, Co. Ltd. This document is a regulatory submission for a Class I medical device (patient examination glove).

Based on the nature of the device (disposable examination gloves) and the content of the provided document, this submission does not involve an AI/ML-driven device, nor does it describe a study with AI/ML specific acceptance criteria, test sets, ground truth establishment, or human-in-the-loop performance evaluation.

The document focuses on demonstrating substantial equivalence to a predicate device (Powder-free PVC Vinyl Exam Gloves, K142703) through non-clinical performance tests for physical characteristics, material properties (like tensile strength, elongation), and biocompatibility (skin irritation, sensitization).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them, as this document pertains to a traditional, non-AI medical device.

To directly answer your prompt, based on the provided text, the following points apply:

• 1. A table of acceptance criteria and the reported device performance: A table is provided (TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES) showing comparison points for physical and performance characteristics of the gloves (e.g., Length, Width, Thickness, Residual Powder, Pinhole Results, Biocompatibility, Tensile Strength, Ultimate Elongations). The "acceptance criteria" here are implicitly meeting or being similar to the predicate device's performance and relevant ASTM standards (ASTM-D-5250-06, ASTM D6124-06, ASTM D5151-06).

• 2. Sample sizes used for the test set and the data provenance:

  • Pinhole Results: "less than two pieces gloves out of 125 pieces gloves." This indicates a sample size of 125 pieces of gloves for pinhole testing.
  • FDA 1000 ml. Water Fill Test: Sample size of "AQL 2.5, Inspection Level I". This is an industry standard sampling plan for quality control rather than a specific number of gloves.
  • Other tests (Tensile Strength, Elongation, Residual Powder, Biocompatibility) do not explicitly state sample sizes in the provided text, beyond general statements like "samplings" or "testing result indicates."
  • Data Provenance: The tests were conducted by the manufacturer, Shandong Zhi Hong Medical Products, Co. Ltd., in China. The data would be retrospective in the sense that it's reported from tests already performed.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and chemical tests is established by standardized testing methods (ASTM standards) and laboratory measurements, not human expert consensus.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for assessing clinical interpretation, not physical product testing.

• 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: Not applicable. This is not an AI/ML device.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the conducted tests is based on standardized laboratory measurements and chemical/physical test results as defined by ASTM standards for glove performance (e.g., direct measurement of length, thickness, tensile strength; water fill test to detect pinholes; chemical analysis for residual powder; in-vivo animal or human patch tests for biocompatibility).

• 8. The sample size for the training set: Not applicable. This is a traditional device, not an AI/ML device requiring a training set.

• 9. How the ground truth for the training set was established: Not applicable. This is a traditional device, not an AI/ML device.

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