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

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text is a 510(k) Summary for a medical device, "Disposable Vinyl Nitrile Synthetic Gloves Powder Free" (K211516). This document details the device's characteristics and its equivalence to a predicate device, as submitted to the FDA.

Based on the nature of the device (disposable patient examination gloves) and the content of the summary, the "device" in question is not an AI/ML-driven diagnostic or assistive technology. Instead, it is a physical medical device. Therefore, the questions related to AI/ML device performance metrics (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size, etc.) are not applicable to this document.

The acceptance criteria and performance are related to the physical properties, safety, and regulatory compliance of the gloves.

Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and how it meets them:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Physical/Performance Tests: The specific sample sizes for each physical test (e.g., number of gloves tested for dimensions, powder content, or tensile strength) are not explicitly stated for all tests. For the watertightness test (ASTM D5151), the result "0/125 leaks" implies a sample size of 125 units were tested.
• Data Provenance: The document does not specify the country of origin for the test data for the subject device beyond the manufacturer being in China. The tests are "non-clinical" (laboratory-based physical and biocompatibility testing), not human clinical studies. The data would be prospective as it's generated specifically for this submission.

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

Not applicable. This is not an AI/ML device requiring expert adjudication/ground truth for image interpretation or diagnosis. The "ground truth" for these physical and biocompatibility tests is based on established laboratory testing methodologies and international standards (ASTM, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for human interpretation of data in studies, not for standardized physical/chemical/biocompatibility testing of a physical product.

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. Performance is of the physical glove itself, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is based on established international standards and laboratory testing protocols (ASTM D5250, ASTM D6124, ASTM D5151, ASTM D412, ISO 10993-5, ISO 10993-10). These standards define the methodologies and acceptance criteria for physical, chemical, and biological properties of examination gloves.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable.

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Powder-Free Yellow Vinyl Patient Examination Gloves is a non sterile 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided text is a 510(k) summary for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria simply do not apply to this document, as it concerns a medical glove and not an AI/ML device.

However, I can extract the relevant information from the document that is analogous to "acceptance criteria" and "reported device performance" for this specific product, a patient examination glove.

Here's the closest interpretation of your request based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves are defined by their conformance to specific ASTM standards and FDA regulations. The "reported device performance" is the statement that the device meets these standards.

The study proving the device meets these criteria is an internal non-clinical testing program conducted by the manufacturer, Tangshan Hongyun Plastic Products Co.,ltd, to ensure compliance with the referenced ASTM standards and ISO standard for biocompatibility.

Regarding the requested information for AI/ML devices (which are not applicable to this document):

2. Sample size for the test set and data provenance: Not applicable. The "test set" here refers to samples of gloves tested according to ASTM standards. The document does not specify exact sample sizes for each test, but rather refers to conformance with standards which typically define sampling plans. The data provenance is internal testing by the manufacturer in China.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical product like a glove is established by standardized measurement methods defined in ASTM standards, not by expert consensus in the way an AI algorithm's output might be.
4. Adjudication method for the test set: Not applicable. Testing for physical properties follows specific protocols defined by the ASTM and ISO standards.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant for a medical glove.
6. Standalone (algorithm only) performance study: Not applicable. This device is not an algorithm.
7. Type of ground truth used: For physical properties, the "ground truth" is the quantitative measurement obtained through standardized tests (e.g., length in mm, thickness in mm, tensile strength in MPa, AQL for pinholes, residual powder in mg/glove, biological response for biocompatibility).
8. Sample size for the training set: Not applicable. This concept is for AI/ML models. For manufacturing, there are quality control processes, but not a "training set" in this context.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (gloves), not an AI/ML device. Therefore, most of the questions relating to AI/ML study design are not addressed. The "acceptance criteria" are the established ASTM and ISO standards, and the "study" is the non-clinical testing performed by the manufacturer to demonstrate compliance with these standards.

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