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Powder free vinyl patient examination glove 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of the Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored). However, it does not include information about a "study" in the traditional sense of a clinical trial or a machine learning model's performance study with separate training and test sets, and expert ground truth establishment. This is a 510(k) premarket notification for a medical device (examination gloves), which primarily relies on conformance to established standards and comparison to a predicate device, rather than a novel algorithm's performance.

Here's a breakdown of the requested information based on the provided text, with explanations for what is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a dataset for evaluating an algorithm. For physical device testing (dimension, physical properties, freedom from pinholes, powder residual), sample sizes would be defined by the respective ASTM standards and 21 CFR regulations, but these specific numbers are not provided in the summary. For biocompatibility, the tests were conducted in animals (rabbits for irritation, guinea pigs for sensitization), but the number of animals is not specified.

Data Provenance: The tests were conducted according to international standards (ASTM, ISO) and US regulations (21 CFR). The location of the testing laboratories is not specified, but the manufacturer is based in China. The "retrospective or prospective" classification is not applicable here as these are laboratory and animal tests, not human studies.

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

This concept is not applicable to the evaluation of examination gloves. Ground truth for these tests is established by adhering to standardized testing protocols and objective measurements (e.g., measuring dimensions, weight of powder, visual inspection for pinholes, observing animal reactions). There are no "experts" establishing a "ground truth" through interpretation similar to medical imaging.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined criteria/standards rather than subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices or technologies (e.g., AI in radiology) where human-in-the-loop performance is being assessed. This document concerns a physical device (examination gloves).

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

No, this is not applicable. The device is a physical examination glove, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the device's conformance is defined by:

• Standard Specifications: Requirements outlined in ASTM standard D 5250-06e1 and ASTM D6124-06.
• Regulatory Requirements: Specifications from 21 CFR 800.20.
• Biocompatibility Standards: Criteria from AAMI / ANSI / ISO 10993-10 for irritation and sensitization.
  These are objective, measurable standards, not expert consensus or pathology in the typical sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The product development and manufacturing processes are controlled to meet the specified standards.

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

Not applicable, as there is no training set for this type of device.

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