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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00€4.

The provided text describes a 510(k) submission for powdered vinyl patient examination gloves. As such, it is not a study about a software-based AI/ML driven medical device, and therefore the requested information regarding acceptance criteria and studies tailored to such devices is largely inapplicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical device (gloves). The typical performance metrics, study designs (e.g., MRMC, standalone), and ground truth establishment methods for AI/ML devices are not relevant here.

However, I can extract the information that is provided and explain why other requested details are not present.

Inapplicability Note:

The provided text describes the regulatory filing for a physical medical device (powdered vinyl patient examination gloves) and not a software-based AI/ML device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable to this type of device and are not detailed in the provided 510(k) summary. The "acceptance criteria" here refer to conformance with established standards for physical properties and safety, not statistical performance metrics of an algorithm.

Extracted Information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Physical and Dimensions: Inspection Level S-2, AQL 4.0 (specific sample size from lot not provided, but these are standard sampling plans).
  • Pinhole/Water Fill Test: AQL 2.5, Inspection level I (specific sample size from lot not provided, but these are standard sampling plans).
  • Biocompatibility: Not explicitly stated how many subjects/samples were used, but standard tests were conducted.
  • Residual Powder: Not explicitly stated how many samples were used, but conducted at finished inspection.
• Data Provenance: Not explicitly stated, implied to be laboratory testing conducted by or for Super Safe Plastic Products Co., Ltd. (China). Retrospective for the purposes of this submission, as the tests were performed prior to submission.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Not Applicable. For a physical device like examination gloves, "ground truth" as understood in AI/ML performance studies does not apply. Performance is assessed against established physical and chemical standards and biocompatibility tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) in AI/ML studies. Here, compliance is determined by objective measurements and standardized tests against predefined criteria.

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

• Not Applicable. This type of study is for evaluating AI assistance to human readers, which is not relevant for a physical examination glove.

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

• Not Applicable. This device is not an algorithm. Performance is inherent to the physical product and its manufacturing process.

7. Type of Ground Truth Used

• Established Standards/Objective Measurements: For aspects like physical dimensions, pinhole defects, residual powder, the "ground truth" is adherence to predefined specifications within recognized industry standards (ASTM D-5250-00E4, ASTM D-6124-06) and regulatory requirements (FDA Water Fill Test). For biocompatibility, it's the observed biological response to the product in standard tests.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set." The manufacturing process involves continuous quality control and testing against established product specifications.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Ever Light Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Physical and Dimensions Testing: Not explicitly stated as a fixed number, but refers to "samplings" and an "inspection level S-2" with "AQL 4.0". This implies a statistical sampling plan rather than a fixed sample size.
• Sample Size for Pinholes (Water Fill Test): Refers to "samplings of AQL 2.5, inspection level I". This also implies a statistical sampling plan.
• Sample Size for Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
• Sample Size for Residual Powder Test: Not explicitly stated.
• Data Provenance: The studies were conducted by Ever Light Plastic Products Co., Ltd. for their product. It is a prospective evaluation of their manufactured gloves. The country of origin of the data would be China, where the manufacturer is located.

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 to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards, FDA water fill test) and expert judgment is not typically involved in the same way it would be for diagnostic imaging or clinical outcomes studies. The reported performance is based on direct measurements and observations during these tests.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., by multiple readers) to resolve discrepancies. For objective performance measures of medical gloves, such as physical properties, leak tests, or biocompatibility, direct measurements are taken, and no adjudication by multiple experts 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

This information is not applicable. This submission is for a medical device (patient examination gloves) that is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is irrelevant.

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

This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is of the physical and biological characteristics of the gloves themselves.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by:

• Performance specifications and testing methods outlined in ASTM-D-5250-00E4.
• FDA requirements for pinholes (1000 ml. Water Fill Test).
• Standardized biocompatibility testing for irritation and sensitization.
• Standardized testing method for residual powder (ASTM D-6124-06).

These standards define the acceptable range or threshold for each property, forming the objective "ground truth" for compliance.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical medical devices like examination gloves. The manufacturing process of gloves is not an AI model that requires training data. Instead, there are quality control and acceptance sampling processes during manufacturing.

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

This information is not applicable as there is no "training set" for this device.

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