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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 5250-06.

The provided text describes the acceptance criteria and performance of "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It does not pertain to an AI/ML device or software. Therefore, many of the requested categories in the prompt are not applicable.

Here's the information that can be extracted relevant to the prompt, acknowledging the nature of the device:

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 exact sample sizes for each test. It refers to adherence to standards like "ASTM standard D 5250-06" and "21 CFR 800.20," which define testing methodologies and sample sizes. The biocompatibility tests were likely prospective studies in animals (rabbits and guinea pigs), as is standard for these tests. The country of origin for the data is not explicitly stated beyond the manufacturing location in China.

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

Not applicable. This device is a physical medical glove and does not involve AI/ML interpretation of data requiring expert ground truth for classification. Performance is determined by objective physical and chemical testing against established standards.

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

Not applicable. Adjudication methods are relevant for subjective assessments, particularly in medical image analysis or similar fields. This device's performance is measured objectively against 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 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.

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

The "ground truth" for this device's performance is established by objective measurements against predefined scientific and regulatory standards. For example:

• Dimensional accuracy: Measured directly against specifications in ASTM D 5250-06.
• Freedom from pinholes: Determined by water leak tests as specified in 21 CFR 800.20.
• Powder amount: Measured gravimetrically against limits in ASTM D 5250-06.
• Biocompatibility: Determined by observing physiological responses in animal models (rabbits for skin irritation, guinea pigs for dermal sensitization) according to ISO10993-10.
  These are all objective measurements, not subjective expert consensus, pathology, or outcomes data in the traditional 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.

Summary of how the device meets acceptance criteria:

The device, "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)," demonstrates it meets acceptance criteria by successfully conforming to established industry and regulatory standards. The study summary indicates that the gloves were tested according to:

• ASTM standard D 5250-06 for characteristics such as Dimension, Physical Properties, and Powder Amount.
• 21 CFR 800.20 for Freedom from pinholes (water leak test).
• ISO10993-10 for Biocompatibility, including Primary Skin Irritation (tested in rabbits) and Dermal Sensitization (tested in guinea pigs).

For all listed characteristics, the "Device performance" is explicitly stated as "Meets" or "Passes," indicating compliance with the respective standards and criteria. The conclusion is drawn that the gloves "meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims," thus demonstrating safety and effectiveness comparable to legally marketed predicate devices.

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