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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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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.

Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.

This document (K992107) describes a submission for "GG" vinyl examination gloves, powder-free, from General Gloves Corp. It is a 510(k) summary, which indicates it's for claiming substantial equivalence to a legally marketed device rather than a de novo approval requiring extensive clinical trials.

Therefore, the document does not contain information about a study proving the device meets acceptance criteria in the way one would expect for a novel medical device like an AI-powered diagnostic tool. Instead, it demonstrates compliance with a recognized standard and compares the device's characteristics to a predicate device.

Here's an analysis based on the provided text, addressing your points where applicable, and noting when the information is not present in this type of submission:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are generally derived from the ASTM D 5250 - 92 standard for patient examination gloves. The reported device performance is stated to meet or exceed these standards.

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

The document mentions "inspection level S-2, AQL 4.0" for dimension/tolerance and physical requirements. These are sampling plans from standards, but the exact sample size (number of gloves tested from a batch) is not explicitly stated in the summary, as it depends on the lot size.

The data provenance is from Taiwan (Tung Chung Village, Tung Shan Hsian, Tainan Hsien, Taiwan, R.O.C.), where General Gloves Corp. is located. The tests would be considered prospective manufacturing quality control tests.

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

This information is not applicable and not provided for this type of device submission. Glove testing relies on standardized physical and chemical tests, not expert interpretation of outputs.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic studies. Glove testing involves objective measurements based on established standards.

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

This information is not applicable. This is a submission for an examination glove, not an AI-powered diagnostic device.

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

This information is not applicable. This is a submission for an examination glove, not an algorithm.

7. The type of ground truth used

The "ground truth" here is compliance with the ASTM D 5250 - 92 standard for patient examination gloves and FDA pinhole requirements. This is based on objective, quantifiable physical and chemical properties of the gloves.

8. The sample size for the training set

This information is not applicable. This is a physical product (glove), not a machine learning algorithm that requires a training set.

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

This information is not applicable. As above, it's not an AI/ML device requiring a training set. The "ground truth" for glove quality is established by adherence to a recognized international standard (ASTM D 5250 - 92).

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