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

A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Vinyl Patient Examination Gloves based on the provided 510(k) summary:

This device is a Class I medical device (21 CFR 880.6250) and a patient examination glove, which is generally subject to general controls and performance standards, rather than an AI/software device that would require the typical studies you've asked about (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts, training set details). The "studies" for this device relate to physical and biological testing to ensure safety and conformance to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for each specific test in the format typically requested for AI/software model testing.

• Pinhole Test: For the FDA 1000 ml Water Fill Test (ASTM D5151-06), the sampling plan used was "AQL 2.5 inspection level G-1." This implies a specific sample size based on the lot size, but the exact number of gloves tested is not provided.
• Other Physical Tests: For physical and dimensions testing (ASTM-D-6319 and ASTM D-5250), the inspection level was S-2, AQL 2.5. Again, the exact sample size for specific tests is not explicitly stated but is determined by the AQL standard applied to the manufacturing lot.
• Biocompatibility Tests: No specific sample size (e.g., number of test subjects or animals) is mentioned for the Primary Skin Irritation and Dermal Sensitization tests.
• Data Provenance: The manufacturing company is Shandong Haoyu Medical Products Co., Ltd. in Qingzhou, Shandong, China. The testing was conducted by the manufacturer or authorized labs, though the specific location of the testing labs is not provided. The data is from retrospective testing of manufactured glove samples.

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

Not applicable. For patient examination gloves, "ground truth" is established by adherence to recognized performance standards (ASTM standards, FDA testing protocols) for physical properties and biocompatibility. There are no "experts" establishing clinical ground truth for a diagnostic outcome like in AI/imaging studies. The "experts" in this context would be the technicians and scientists performing the standardized tests according to documented procedures.

4. Adjudication Method for the Test Set

Not applicable. This device relies on standardized physical and biocompatibility testing, not on human interpretation or adjudication processes like 2+1 or 3+1 consensus commonly used for expert review of medical images or data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for diagnostic or AI-assisted devices where human readers interpret data with or without AI assistance. This device is a physical barrier (glove), so such a study is not relevant.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical product, not a software algorithm.

7. Type of Ground Truth Used

For examination gloves, the "ground truth" is defined by:

• Performance Standards: Adherence to established ASTM standards (D5250-06, D5151-06, D6124-06) for physical properties, dimensions, pinhole integrity, and residual powder.
• Biocompatibility Testing: Results from primary skin irritation and dermal sensitization tests demonstrating non-irritant and non-sensitizing properties. These tests are standardized methods.

8. Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning. The manufacturing process is controlled and optimized, but there's no data-driven model training involved.

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

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

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