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Powder-Free Yellow Vinyl Patient Examination Gloves is a non-sterile 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Powder-Free Yellow Vinyl Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The study proving the device meets the acceptance criteria is a nonclinical study focused on demonstrating substantial equivalence to a predicate device.

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

• The document does not explicitly state the sample size used for testing each specific characteristic (e.g., number of gloves tested for length, width, tensile strength, pinholes, residual powder, or biocompatibility).
• The data provenance is China (Zibo Litong Plastic Products Co., Ltd. is located in Zibo, Shandong, China).
• The study is retrospective in the sense that it relies on product testing to demonstrate conformance to existing standards and comparison to a legally marketed predicate device, rather than a new prospective clinical trial.

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

• The document does not specify the number of experts or their qualifications for establishing ground truth for the test set. The "ground truth" here is defined by established performance standards (ASTM standards, 21 CFR regulations, ISO standards) and comparison to a predicate device. The testing would have been conducted by trained personnel in a laboratory setting.

4. Adjudication method for the test set:

• The document does not describe an adjudication method in the context of expert review for the test set. The assessment appears to be based on direct measurement and laboratory testing against pre-defined quantitative and qualitative 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices involving human interpretation. This device is a patient examination glove, and the regulatory pathway does not require or involve such studies.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical medical device (glove), not a software or AI algorithm.

7. The type of ground truth used:

• The ground truth used is primarily based on established industry standards and regulatory requirements, including:
  • ASTM D5250-06 (Reaffirmation 2011) - for physical properties, dimensions, etc.
  • ASTM D5151-06 (Reapproved 2011) - for freedom from pinholes (water leak test).
  • ASTM D6124-06 (Reaffirmation 2011) - for residual powder.
  • 21 CFR 800.20 - for freedom from pinholes.
  • ISO 10993-10 (2002/Amd.1:2006 and Third Edition 2010-08-01) - for biocompatibility (skin irritation and sensitization).
  • The characteristics of a legally marketed predicate device (Hebei Leader Plastic Co., Ltd. K122920) serve as a comparative ground truth for demonstrating substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not a machine learning model. Therefore, 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 a machine learning model, no ground truth was established for it.

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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 a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

The provided text describes a 510(k) premarket notification for "Zibo Litong Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free." This is a Class I medical device (patient examination glove), which, by its nature, does not typically involve AI components or complex diagnostic algorithms. Therefore, the specific questions regarding AI performance metrics, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this type of medical device submission.

The acceptance criteria and studies focus on the physical properties and biocompatibility of the gloves, ensuring they meet established ASTM standards and FDA requirements for patient examination gloves.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5. (Specific sample size not explicitly stated, but determined by ASTM D5250-06 and the AQL).
• Water Fill Test: AQL 2.5, Inspection Level I. (Specific sample size not explicitly stated, but determined by FDA requirements and the AQL).
• Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but implied to be conducted on relevant biological samples.
• Data Provenance: The device is manufactured by Zibo Litong Plastic Products Co., Ltd. in Zibo, China. The testing was conducted to meet US FDA and ASTM standards. The text does not specify the country of origin for the "data" from skin irritation/sensitization tests, but typically, these tests are performed in accredited labs. The studies are essentially "retrospective" in the sense that the testing was performed on manufactured gloves to demonstrate compliance for the submission.

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

• This question is not applicable. The "ground truth" for glove performance is established by objective physical and chemical testing against defined standards (ASTM and FDA). It does not involve expert readers or diagnostic interpretations.

4. Adjudication method for the test set

• This question is not applicable. Adjudication is relevant for subjective assessments, primarily in clinical trials or image interpretation. Glove testing involves objective measurements.

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 question is not applicable. This device is a medical glove, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• This question is not applicable. There is no AI algorithm in this device.

7. The type of ground truth used

• For physical and performance characteristics: Objective measurements against defined industry standards (ASTM D5250-06) and regulatory requirements (FDA 1000 ml Water Fill Test, chemical analysis for powder content).
• For biocompatibility: Results from primary skin irritation and skin sensitization tests.

8. The sample size for the training set

• This question is not applicable. There is no "training set" in the context of an AI model for this device. The manufacturing process is controlled to consistently produce gloves that meet the specifications, but there isn't a machine learning training phase.

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

• This question is not applicable for the same reason as point 8.

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