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

Class I powder-free patient examination glove LYZ, meets all of the requirements of ASTM Standard D5250-00E1. Class I powdered patient examination glove, LYZ, also meets all the requirements of ASTM Standard D5250-00E1. as well as all the requirements of ASTM Standard D6124-01 for powdered glove and its residue powder.

The provided text describes a 510(k) summary for disposable PVC examination gloves. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a clinical study with performance metrics. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set) is not applicable or cannot be extracted from this document, as it pertains to a different type of regulatory submission or product evaluation.

Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to predicate devices. This means the device must be as safe and effective as legally marketed devices. Another criterion mentioned is adherence to ASTM Standard D5250-00E1 (for both powdered and powder-free gloves) and ASTM Standard D6124-01 (for powdered gloves and residue powder). It also mentions meeting "pinhole FDA requirements," "biocompatibility requirements," and "labeling claim requirements."
• Reported Device Performance: The document states that the device "meets all of the requirements" of the specified ASTM standards and "meets pinhole FDA requirements, biocompatibility requirements and labeling claim requirements." It confirms substantial equivalence based on "Non-clinical tests."

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

• Not Applicable/Not Provided. The document refers to "Non-clinical tests" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective). This is common for device submissions like examination gloves where performance is typically assessed through standardized laboratory tests and material properties rather than clinical test sets with human subjects.

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

• Not Applicable/Not Provided. Ground truth established by experts is typically relevant for diagnostic devices or AI algorithms. For examination gloves, performance is assessed against physical and chemical standards.

4. Adjudication method for the test set:

• Not Applicable/Not Provided. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among experts in ground truth establishment for diagnostic or subjective assessments, which isn't the case for examination gloves.

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 medical device (examination glove), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used:

• Standard Specifications and Laboratory Test Results: The "ground truth" here is the adherence to established industry standards (ASTM D5250-00E1, ASTM D6124-01) and specific FDA requirements for glove performance (e.g., pinhole, biocompatibility). Performance is measured through non-clinical laboratory tests.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. As above, no training set is involved.

Summary of what can be extracted:

The 510(k) summary indicates that the device's acceptance criteria are based on substantial equivalence to existing predicate devices and compliance with specific ASTM standards and FDA requirements (pinhole, biocompatibility, labeling). The "study" that proves this involves non-clinical laboratory tests that demonstrate the device meets these standards and requirements. No human subject studies, expert consensus, or AI performance evaluations are detailed in this type of submission.

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