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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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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 5250-06.

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)":

This device, a patient examination glove, is a Class I medical device, which typically requires less rigorous testing than higher-class devices. The primary focus of the testing is to demonstrate substantial equivalence to a predicate device and adherence to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each test (e.g., for dimension, physical properties, pinholes, powder residual, or biocompatibility). It references adherence to standards like ASTM D5250-06, 21 CFR 800.20, and ISO10993-10, which would typically specify minimum sample sizes for individual tests.

The data provenance implies that the testing was conducted by the manufacturer, SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD, located in China. The testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate compliance with the standards.

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

This type of device (patient examination glove) does not typically involve human expert interpretation of results in the way, for example, a diagnostic imaging AI algorithm would.

• For physical and chemical tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual), the "ground truth" is established by the specifications of the referenced ASTM standards and 21 CFR regulations. The results are quantitative measurements compared against predefined thresholds.
• For biocompatibility tests (Primary Skin Irritation, Dermal Sensitization), the "ground truth" is established by observing animal responses (rabbits for irritation, guinea pigs for sensitization) against established protocols (ISO 10993-10) and interpretation by trained toxicologists or scientists. The number and specific qualifications of these experts are not stated in this summary, but would be implicit in the conduct of these standardized tests.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The "adjudication" is essentially the direct comparison of measured device characteristics against the objective, pre-defined criteria in the referenced standards. There isn't a scenario described where multiple interpretations of data would require an adjudication process by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is typically conducted for diagnostic devices where human readers (e.g., radiologists) interpret medical images or data, and the study compares their performance with and without AI assistance. A patient examination glove is a simple barrier device, not a diagnostic tool, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is also not relevant. The device is a physical product (a glove), not an algorithm. The performance is assessed through laboratory testing of its physical and biological properties.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by:

• Standard Specifications: For mechanical properties (dimension, physical properties, pinholes, powder residual), the ground truth is the quantitative limits defined by ASTM standards (D 5250-06, D6124-06) and 21 CFR 800.20.
• Biological Response Protocols: For biocompatibility, the ground truth is determined by the observed biological reactions in animal models following the established protocols of ISO 10993-10 (often interpreted as "Pass" or "Fail" based on whether reactions exceed certain thresholds).

Essentially, it's a combination of objective measurement against predefined criteria and standardized biological testing outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable, as there is no "training set" for this device.

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