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Powder free vinyl patient 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)

Summary of Device Performance Study:

The provided text describes a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies for Class I devices like examination gloves. The "study" in this context refers to the nonclinical tests conducted to prove the device meets established standards and is comparable to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact sample sizes used for each of the nonclinical tests (Dimension, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility). It only states that the device "meets" the standards.
• Data Provenance: The tests are nonclinical, laboratory-based evaluations against established material and performance standards. The country of origin of the data is not explicitly stated, but it would have been generated in a laboratory setting. The data is prospective in the sense that the manufacturer conducted these tests specifically for this device to demonstrate compliance prior to submission.

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

• This is not applicable in the context of this submission. For nonclinical tests like those for examination gloves, the "ground truth" is defined by the objective, measurable parameters outlined in the ASTM and CFR standards. Expert consensus or review by human experts with specific qualifications (like radiologists) is typically not involved in establishing the ground truth for these types of physical and chemical performance tests. Laboratory technicians and chemists would perform these tests against the predefined standards.

4. Adjudication Method for the Test Set:

• This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, particularly in medical image analysis or clinical assessments. For objective nonclinical tests, the results either meet the specified numerical or qualitative criteria of the standard, or they do not. There's no "adjudication" in the traditional sense; rather, it's a direct comparison of measured results against published thresholds.

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 devices, particularly those involving human interpretation (e.g., radiology AI). The device in question is a physical barrier (examination glove), and its performance is assessed through nonclinical, laboratory-based tests against material and functional standards, not by human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No, this is not applicable. A standalone algorithm performance study is relevant for AI/ML-based diagnostic devices. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

• The ground truth used for these nonclinical tests is based on established industry and regulatory standards and specifications. Specifically:
  • ASTM Standard D 5250-00c4: For dimensions, physical properties, and powder residual. These standards define the acceptable ranges and methodologies.
  • 21 CFR 800.20: For freedom from pinholes (waterleak test AQL). This is a regulatory standard defining acceptable defect rates.
  • ASTM D6124-01: For powder residual, providing a specific methodology and threshold.
  • ISO10993-10: For biocompatibility, which outlines methods for testing irritation and sensitization. The "ground truth" for biocompatibility is derived from the biological responses (or lack thereof) observed in animal models (rabbits for irritation, guinea pigs for sensitization), interpreted according to the standard.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on the inherent physical and chemical properties of the manufactured product, which are tested against defined standards.

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

• Not applicable. As the device is not an AI/ML algorithm, there is no training set or corresponding ground truth to establish in that context.

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