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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary for a general medical device (patient examination gloves). As such, the "study" referred to is primarily non-clinical testing against established standards, not a clinical trial in the way one might think of it for drug development or complex diagnostic AI. The questions provided in the prompt are more geared towards AI/software as a medical device (SaMD) evaluations, so some sections will reflect that the information is not directly applicable or available in this type of submission.

Acceptance Criteria and Device Performance

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

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

The document does not specify the exact sample sizes used for each test. The provenance is not explicitly stated as 'country of origin of data,' but the testing standards (ASTM, FDA CFR, ISO) are international/US standards. This is non-clinical performance testing.

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. Ground truth for these physical and chemical tests is established by adhering to the methodologies described in the cited ASTM, 21 CFR, and ISO standards by qualified testers, rather than expert consensus on images or diagnoses.

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

Not applicable. This is not a human-adjudicated test set; it involves objective measurements against established technical 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

Not applicable. This is a physical medical device (gloves), not an AI/software device. There is no concept of "human readers" or "AI assistance" in this context.

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

Not applicable. This is a physical medical device (gloves), not an AI/software device.

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

The ground truth used is based on established, objective measurement methods defined in international and US standards (ASTM D5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10) for physical properties, chemical residue, and biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm or AI. Product development and manufacturing 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 training set for a physical medical device like this.

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This 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.

Requested information about the acceptance criteria and study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to patient examination gloves, which undergo non-clinical testing rather than classification with a "test set" in the context of AI/ML or medical imaging devices. The tests are performed on samples of the manufactured gloves. The document does not specify exact sample sizes for each test but refers to standard testing methods. The data provenance is derived from direct testing of the manufactured gloves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For medical device manufacturing like gloves, "ground truth" is established by adherence to specified physical, chemical, and biological standards (e.g., ASTM, CFR). No human experts are used to subjectively determine a "ground truth" for the test set in the way they would for diagnostic imaging.

4. Adjudication method for the test set: Not applicable. Since the evaluation relies on objective measurements against predefined standards, no subjective adjudication method (like 2+1 or 3+1 consensus) is required.

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 device is a patient examination glove, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used: The ground truth is defined by objective, quantitative, and qualitative criteria established in international and national standards (ASTM standard D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards specify acceptable ranges for dimensions, physical properties, limits for pinholes, maximum powder residual, and biological response criteria for biocompatibility tests.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of manufacturing and testing patient examination gloves.

9. How the ground truth for the training set was established: Not applicable. There is no "training set" for this type of device. The established standards are the "ground truth" against which all manufactured gloves are evaluated.

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