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Powdered 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding the acceptance criteria and study for the ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO.,LTD Powdered Vinyl Patient Examination Gloves (K070008):

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample size used for the test set for any of the performance measures.

The data provenance is also not explicitly stated. It's likely that the testing was conducted internally by ZIBO HENGDE PLASTIC&RUBBER PRODUCTS CO.,LTD or by a contracted laboratory, but the country of origin of the data is not mentioned. Given the company's location (China), it's probable the testing occurred there. This was a retrospective submission, as the notification was prepared and submitted for a device that had already undergone testing.

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

Not applicable/Not mentioned. This submission concerns a physical medical device (gloves) and its mechanical and biological properties. The "ground truth" here is objective measurement against established standards (ASTM, FDA regulations) and biological assays (rabbit irritation, guinea pig sensitization), rather than expert interpretation of complex data (like medical images) that would require a panel of experts.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. As noted above, the "ground truth" is based on objective measurements and established test protocols, not subjective interpretation 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 is not relevant for this type of medical device (patient examination gloves). MRMC studies are typically used for diagnostic devices that involve human interpretation (e.g., radiologists reading medical images) to assess the impact of AI assistance on human performance. This submission focuses on the standalone performance of the physical glove.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The entire evaluation is based on the standalone performance of the device itself (the glove) against established objective standards and biological tests. There is no "algorithm" or "human-in-the-loop" component for this product. The device's performance characteristics (dimension, physical properties, pinhole freedom, powder amount, biocompatibility) were tested directly without human intervention or AI assistance.

7. The Type of Ground Truth Used

The ground truth used is a combination of:

• Established Industry Standards: Primarily ASTM standard D 5250-00e4.
• Regulatory Requirements: 21 CFR 800.20 (for pinholes).
• Pre-defined Biological Assay Outcomes: For biocompatibility (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs), where "Passes" or "Not a Primary Skin Irritation/Dermal sensitization" are the ground truth for an acceptable result.
• Other Standards: ASTM D6124-01 and ISO10993-10 are also referenced for meeting requirements (though not explicitly detailed in the table).

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of the gloves would involve quality control and process validation, but this is distinct from an AI training set.

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

Not applicable. As there is no AI/ML training set, there is no ground truth established for it.

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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-000

The provided document describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" and not an AI/ML device. Therefore, many of the requested categories for AI/ML device evaluation are not applicable.

Here's the information that can be extracted from the provided text regarding the glove's acceptance criteria and how its compliance was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the testing of these gloves. The testing is based on compliance with ASTM standards, 21 CFR regulations, and ISO standards, which typically involve standardized methods for sampling and testing. No specific data provenance (country of origin, retrospective/prospective) is mentioned beyond the standards themselves.

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

This is not applicable as the device is a medical glove, not an AI/ML diagnostic or assistive device. Ground truth is established by standardized physical and chemical testing methods, not expert interpretation.

4. Adjudication method for the test set

This is not applicable for a medical glove. The compliance is determined by laboratory testing against established physical, chemical, and biological 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 is not applicable as the device is a medical glove.

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

This is not applicable as the device is a medical glove.

7. The type of ground truth used

The "ground truth" for the medical glove is established by adherence to:

• Performance Standards: ASTM standard D 5250-00cd for Dimensions, Physical Properties, and Powder Residual.
• Regulatory Standards: 21 CFR 800.20 for Freedom from pinholes.
• Biocompatibility Standards: ASTM D6124-01 (for powder residual), ISO10993-10 for biocompatibility evaluation (Primary Skin Irritation and Dermal sensitization).

These standards define the objective criteria that the glove must meet.

8. The sample size for the training set

This is not applicable as the device is a medical glove. There is no "training set" in the context of an AI/ML device. The manufacturing process is designed to consistently produce gloves that meet the specified standards.

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

This is not applicable as the device is a medical glove.

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