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The 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 blue nitrile patient examination glove, tested for use with Chemotherapy drugs, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

The provided documentation describes the acceptance criteria and performance of the "Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. This device is a patient examination glove used to prevent contamination between patient and examiner.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The standard ASTM D6319, ASTM D6124, and ASTM D5151 inherently contain specific acceptance limits for metrics like tensile strength, elongation, dimensions, freedom from holes, and powder residual. The document states the device "Meets" these standards, indicating compliance with all their respective criteria. For Powder Residual, a specific value is provided (<2mg), which is typically the acceptance criterion for powder-free gloves.

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 explicitly state the sample sizes used for each specific test (Dimension, Physical Properties, Pinholes, Powder Residual, Biocompatibility). The tests refer to ASTM and ISO standards, which would outline the appropriate sampling plans and methodologies.

The "data provenance" (country of origin, retrospective/prospective) is not provided in the document. The applicant, Northstar Healthcare Holdings, is based in Dublin, Ireland, and the official correspondent (Cypress Medical Products LLC) is in McHenry, IL, USA. However, the location where the testing was conducted is not specified. It is likely prospective testing as it's a product performance evaluation for a 510(k) submission.

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

This device is a patient examination glove, and its performance is evaluated against established physical and biocompatibility standards (ASTM D6319, D5151, D6124, ISO 10993-10) rather than requiring expert interpretation of diagnostic images or clinical outcomes. Therefore, the concept of "experts" establishing ground truth in the way it applies to diagnostic devices (e.g., radiologists interpreting images) is not applicable here. The "ground truth" is determined by objective measurements performed according to the specified standards by trained laboratory personnel.

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

Not applicable. The tests involve objective measurements and adherence to industry standards, not subjective interpretations requiring adjudicated consensus.

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 device is a disposable patient examination glove; it is not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is a physical product, not an algorithm.

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

The "ground truth" for this device's performance is based on objective measurements against established national and international standards. These include:

• Physical Property measurements: e.g., tensile strength, elongation, dimensions as per ASTM D6319.
• Freedom from Pinholes: Determined by water leak tests as per ASTM D5151 and D6319.
• Powder Residual measurement: As per ASTM D6124.
• Biocompatibility testing: In-vivo assays (rabbit irritation, guinea pig sensitization) as per ISO 10993-10.

8. The sample size for the training set

Not applicable. This is a physical product, not a machine learning model, so there is no concept of a "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, there is no ground truth established for a training set.

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