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Powder Free Blue Patient Nitrile Examination Gloves 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.

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6319-05

The provided document describes the acceptance criteria and the study conducted for the Nitrile Powder Free Patient Examination Gloves (Blue). This is a medical device subject to regulatory clearance, and the study focuses on non-clinical performance to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Class I vinyl patient examination gloves 80LYZ,powder-free,that meets all the requirements of ASTM D 5250-00.

This document is a 510(k) Pre-market Notification for a medical device, specifically Vinyl Patient Examination Gloves, Powder-Free. It outlines the device's technical characteristics and intended use but does not contain information about a study proving the device meets specific acceptance criteria related to diagnostic accuracy or AI performance.

The information provided pertains to the physical and biocompatibility properties of the gloves, comparing them to an ASTM standard. It's a regulatory submission for a Class I medical device, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving diagnostic performance.

Therefore, I cannot provide answers to the questions you've asked regarding acceptance criteria related to diagnostic accuracy, AI performance, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information presented in the provided text.

The closest relevant information, regarding "acceptance criteria" for this device, would be the physical requirements outlined for the gloves to meet the ASTM D 5250-00 standard for patient examination gloves.

Here's an attempt to fill in the table with the available physical requirements and implied performance:

1. Table of acceptance criteria and the reported device performance

Regarding the other questions, based on the provided text, the answers are N/A (Not Applicable) or "Information Not Provided":

• 2. Sample sized used for the test set and the data provenance: N/A. This document describes the physical properties of gloves, not a diagnostic device with a "test set" in the context of clinical performance data. The testing is for physical properties (e.g., batch testing for dimensions, tensile strength). Data provenance is from "TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD."
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for diagnostic performance is not relevant here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
• 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: N/A. This is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device relates to meeting physical specifications defined by the ASTM standard.
• 8. The sample size for the training set: N/A. This is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: N/A.

In summary, this document describes a medical device (examination gloves) that meets industry standards for physical properties and biocompatibility, as required for its regulatory clearance. It does not involve AI, diagnostic performance, or extensive clinical study designs as typically outlined for software as a medical device (SaMD) or AI-enabled diagnostic tools.

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

Class I vinyl patient examination gloves 80LYZ,powdered,that meets all the requirements of ASTM D 5250-00.

The provided text describes a 510(k) premarket notification for "Vinyl Examination Gloves, Powdered." This is a medical device submission, but it outlines the equivalence of the gloves to a legally marketed predicate device rather than detailing an AI/ML-based diagnostic system. As such, many of the requested categories (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, and ground truth establishment for AI) are not applicable to this type of submission for a physical medical device like gloves.

However, I can extract the acceptance criteria and how the device (gloves) is shown to meet them based on the information provided.

Acceptance Criteria and Device Performance (Vinyl Examination Gloves)

This submission focuses on demonstrating substantial equivalence to a predicate device, specifically "Class I vinyl patient examination gloves 80LYZ, powdered, that meets all the requirements of ASTM D 5250-00." The acceptance criteria for the new device are directly linked to meeting the requirements of this ASTM standard and other specified tests.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is primarily a bench-testing and materials characterization study, as is typical for non-software/AI medical devices like examination gloves. The submission is a demonstration of substantial equivalence to an existing predicate device based on adherence to recognized standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document explicitly mentions "Sampling procedure and acceptance quality level" for the Pin Hole test. While the exact number of gloves tested is not provided in this summary, it would be determined by the specific "sampling procedure" and "acceptance quality level" (AQL) outlined for the FDA 1000ml water leak test. These AQL tables specify the sample sizes required to make an inference about the quality of a lot.
• Data Provenance: The studies were conducted by "TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD." which is located in "LUANNAN, TANGSHAN CITY, HEBEI PROVINCE, CHINA." This indicates the data originated from China, likely from internal company testing. The data would be prospective in the sense that the manufacturer tested their produced gloves to ensure they meet the standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. For a physical product like examination gloves, "experts" in the sense of clinical specialists establishing a "ground truth" for diagnostic accuracy are not relevant. The "ground truth" here is adherence to specified physical and material properties, which are measured objectively using standardized laboratory tests by qualified quality control personnel.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, particularly in diagnostic imaging or clinical trials. For objective physical and chemical tests (e.g., measuring tensile strength, performing a water leak test), the results are quantitative and do not typically require expert adjudication in this manner. Standard laboratory practices for quality control and verification would be followed.

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 a physical product (gloves), not an AI/ML diagnostic device. MRMC studies are used for evaluating physician performance with and without AI assistance for diagnostic tasks.

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

• Not Applicable. This is a physical product (gloves), not an AI algorithm.

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

• The "ground truth" for these gloves is defined by the objective, measurable standards outlined in ASTM D 5250-00 (e.g., specific values for tensile strength, elongation, dimensions) and the performance criteria for the FDA 1000ml water leak test (e.g., maximum allowed pinholes per sample size). It relies on standardized test methods and predefined quantitative thresholds, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set.

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