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HEALTH + AID ° PREMIUM Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

HEALTH + AID ® PREMIUM Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 -- 95, Standard Specificatio for Rubber Examination Gloves. They are blu or natural white in colour.

The provided text describes a 510(k) summary for HEALTH + AID® PREMIUM PRE - POWDERED NITRILE EXAMINATION GLOVES. This document is a regulatory submission for a medical device (examination gloves) and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study on an AI/ML powered device.

Therefore, many of the requested details, such as those related to AI/ML powered devices, ground truth, expert adjudication, multi-reader multi-case studies, and specific accuracy metrics, are not applicable or not present in this document.

However, I can extract information related to the acceptance criteria for these gloves and the nonclinical testing performed to meet those criteria.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document explicitly states that the device meets "all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves," even though earlier text states the predicate device met D 3578-95 except for tensile strength and ultimate elongation. This suggests the new device is being compared against the full D 3578-95 standard, or the "EXCEPT" clause was hyper-specific to the predicate claim and not the current device's compliance. Given the "Brief Discussion of Nonclinical Tests" states "Gloves meet all the current specifications listed under the ASTM Specification D 3578 - 95," this is the performance claim.

Additional Information (as requested, but largely N/A for this document type):

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

• Not applicable. This document describes nonclinical, physical, and biocompatibility testing of a physical product (gloves), not a software device or an AI/ML algorithm that would use a test set of data in the common sense. The testing is performed on samples of the manufactured gloves. The document does not specify sample sizes for these tests, nor data provenance in terms of country of origin for a data set.

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

• Not applicable. "Ground truth" in the context of expert consensus is not relevant here. The ground truth for glove performance is defined by standardized test methods (e.g., ASTM D 3578-95) and the objective measurements derived from them. Biocompatibility tests are performed by qualified laboratories and personnel following established protocols, but the concept of "experts establishing ground truth for a test set" like in AI/ML is not applicable.

4. Adjudication method for the test set:

• Not applicable. This concept relates to conflicting interpretations from multiple experts on a diagnostic image or data point. For physical product testing as described, the results are typically quantitative measurements that either pass or fail a predefined limit.

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 physical product (examination gloves), not an AI-powered diagnostic device. No MRMC study was conducted.

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

• Not applicable. This is a physical product (examination gloves), not an algorithm or software.

7. The type of ground truth used:

• For physical properties and barrier integrity: Objective measurements against ASTM standards.
• For biocompatibility: Animal study results (irritation, sensitization) and chemical tests (starch presence). These are considered direct evidence of the device's properties as per regulatory guidelines at the time.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The manufacturing process itself (and quality control checks on manufactured batches) could be seen as analogous to continuous learning and validation, but not in the AI/ML sense.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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