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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized as requested:

Device: Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm² of glove or Less of Water Extractable Protein)

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 sample sizes used for the specific tests (e.g., freedom from pin-holes, protein content). It only refers to compliance with the ASTM and ISO standards, which would implicitly define sample sizes for those tests. The data provenance is not specified beyond indicating that Top Calibre Sdn Bhd, a Malaysian company, submitted the information. It is a retrospective compilation of compliance to existing standards rather than a prospective clinical trial.

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

Not applicable. The ground truth for this device is based on adherence to established international and national standards (ASTM, ISO) for medical gloves. This does not involve expert consensus on an "image" or "diagnosis" but rather laboratory and performance testing against objective criteria defined by these standards.

4. Adjudication Method for the Test Set

Not applicable. As the device's performance is measured against objective, published standards, there would be no "adjudication" in the sense of reconciling differing expert opinions. The tests conducted according to the standards would yield measurable results that either meet or do not meet the specified criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support AI, where human performance is evaluated with and without AI assistance. This device is a physical examination glove, and its effectiveness is determined by its physical properties and biocompatibility, not by assisting human readers in interpreting clinical data.

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

Yes, the testing described appears to be standalone in the sense that the device itself (the glove) was subjected to laboratory tests and its performance was measured against predefined standards without direct human-in-the-loop performance evaluation in a clinical setting for primary efficacy. The performance metrics are objective physical and chemical properties.

7. Type of Ground Truth Used

The ground truth used is based on established national and international standards for medical gloves. This includes:

• Physical properties defined by ASTM D 3578-05 (2010)
• Freedom from pin-holes defined by ASTM D 5151-99 (2006)
• Powder-free residue defined by ASTM D 6124-06
• Protein content defined by ASTM D 5712-10
• Biocompatibility (dermal sensitization and primary skin irritation) defined by ISO 10993-10:2010

8. Sample Size for the Training Set

Not applicable. This device is an examination glove, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of the gloves would be subject to quality control, but this is distinct from an algorithm's training data.

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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