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Powder free vinyl 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.

Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Powder-free Vinyl Patient Examination Gloves, Colored (Yellow).

It's important to note that this document is for a Class I medical device (patient examination gloves). For devices of this classification, the regulatory requirements are generally less stringent compared to higher-risk devices, and often the "studies" primarily involve adherence to recognized standards rather than complex clinical trials or AI performance evaluations.

Here is the requested information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state specific sample sizes for each test in the acceptance criteria table. However, it references ASTM standard D 5250-06, 21 CFR 800.20, ASTM D6124-01, and ISO10993-10. These standards typically specify the appropriate sampling plans and methodologies for testing.

• Data Provenance: The document does not specify the country of origin of the data. It's likely that the testing was conducted by the manufacturer (Tangshan Kangyuan Glove Co., Ltd. in China) or a contracted lab. The testing for a device of this nature is generally retrospective in the sense that batches of manufactured gloves are sampled and tested according to the standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The concept of "ground truth established by experts" is not directly applicable in the context of testing these types of medical gloves. The performance of these gloves is assessed against objective physical and chemical standards rather than subjective expert interpretation.

• Experts: N/A for establishing "ground truth" as it's typically understood in AI/clinical studies. The "experts" in this context would be the technicians and scientists performing the standard-based tests and interpreting the results according to the specified criteria. Their qualifications would be in laboratory testing, materials science, or related fields, with expertise in executing the cited ASTM, CFR, and ISO standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where subjective interpretations (e.g., image readings) need consensus. For objective physical and chemical tests on gloves, the results are typically quantitative or directly pass/fail according to the standard, not requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiology AI), to evaluate how AI assistance impacts reader performance. It is not applicable to patient examination gloves.

• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical product (gloves), not an AI algorithm. Therefore, the concept of algorithm-only performance does not apply.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements and assessments against established industry standards and regulations. This includes:

• ASTM D 5250-06: Standard Specification for Poly(vinyl chloride) Patient Examination Gloves. This standard dictates physical properties, dimensions, and other performance characteristics.
• 21 CFR 800.20: FDA regulation concerning the water leak test (freedom from pinholes) for medical gloves.
• ASTM D6124-01: Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization (for biocompatibility).

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train an AI model. This device is not an AI algorithm or software and therefore does not have 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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