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A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.

The Nitrile Exam Gloves, Powder Free, Black, Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.

The provided text is for a 510(k) premarket notification for "NITRILE EXAM GLOVES, POWDER FREE, BLACK". This document describes the characteristics and testing of a medical device (nitrile examination gloves), not an artificial intelligence (AI) or algorithm-based device. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert review, and training/test set sample sizes are not applicable.

Here's an analysis of the available information:

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 specify exact sample sizes for each test. It states that "Testing performed per ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20." These standards would dictate the sampling plans and methodologies.

• Data Provenance: The manufacturing company is Central Medicare Sdn. Bhd. located in Malaysia. Testing would have been conducted to demonstrate compliance with ASTM and CPSC standards, which are international and US-based, respectively. While not explicitly stated, testing would be prospective for the purpose of this submission.

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

Not applicable. This is a physical device, and the ground truth is established through standardized physical, chemical, and biological testing methods, not expert interpretation of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a physical device. Test results are objective measurements against predefined 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

Not applicable. This device is not an AI or algorithm-based product.

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

Not applicable. This device is not an AI or algorithm-based product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is based on:

• Standardized Measurement: Physical dimensions, tensile strength, elongation, and powder residue are measured against the specifications outlined in ASTM standards.
• Defined Thresholds: Freedom from pin-holes is assessed against AQL (Acceptable Quality Level) criteria.
• Biological Response Protocols: Biocompatibility (dermal sensitization and primary skin irritation) is determined by conducting standardized animal tests (guinea pigs and rabbits) and observing the biological response according to established protocols from ASTM and CPSC. The "ground truth" is the absence of irritation or sensitization as defined by these protocols.

8. The sample size for the training set

Not applicable. This device is not an AI or algorithm-based product, so there is no training set in that context.

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

Not applicable. This device is not an AI or algorithm-based product.

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