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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.

Nitrile Powdered patient examination glove

The provided text is a 510(k) Premarket Notification for Nitrile Powdered Examination Gloves. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on nonclinical data.

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

1. A table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes for each test set that led to the "Meets" determination. It references ASTM and ISO standards for testing, which would outline the appropriate sample sizes and methodologies for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility).

The data provenance is from nonclinical testing conducted by the manufacturer (Northstar Healthcare Holdings) or a designated testing facility on their behalf, designed to demonstrate compliance with established standards. No specific country of origin or retrospective/prospective nature of the data is mentioned beyond the standards themselves.

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

This information is not applicable as the device is a patient examination glove. The "ground truth" for this type of device is established by compliance with standardized physical performance and biocompatibility tests, not by expert interpretation of images or clinical data. The standards (ASTM, ISO) themselves define the criteria for "ground truth" or acceptable performance.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, often with conflicting opinions, requiring a consensus mechanism. For the nonclinical testing of gloves, the results are quantitative measurements against predefined thresholds specified in the ASTM and ISO standards.

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

This is not applicable. This device is a physical medical device (examination glove), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This is not applicable as the device is not an algorithm or an AI system. Its performance is evaluated through physical and biocompatibility testing.

7. The type of ground truth used

The ground truth for this device is based on established industry standards (ASTM and ISO), which define objective, measurable criteria for physical properties (dimensions, tensile strength, elongation, freedom from pinholes, powder residual) and biological safety (biocompatibility). The tests measure these characteristics directly against the specified thresholds.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML device that requires a training set. Its performance is assessed through direct testing against predetermined criteria.

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

This information is not applicable for the same reason as point 8.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.

This document describes the acceptance criteria and performance of the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue and Green).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each test. However, the performance data is based on the ASTM D3578-95 standard and the FDA 1000 ml watertight test, which would typically specify sampling plans. The data provenance is from SEAL POLYMER INDUSTRIES SDN. BHD. in Lahat, Perak, Malaysia. The study appears to be a retrospective analysis of product performance against established standards.

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

This information is not provided in the document. For product performance testing against standard specifications like ASTM D3578-95, the "ground truth" is typically defined by the objective measurement procedures within the standard, not by expert consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. The performance data is based on objective measurements and compliance with a standard (ASTM D3578-95) and FDA requirements, not on subjective interpretations requiring adjudication.

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 submission for a medical glove, a physical device, and not an AI-powered diagnostic or decision support tool that would involve human readers.

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

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

7. The type of ground truth used:

The ground truth used for performance evaluation is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-95 Standard for Rubber Examination Gloves.
• FDA 1000 ml watertight test for pinhole requirements.
• FDA requirements for minimum powder residual content.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. This is a physical medical device.

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