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APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

APOLLO ADVANTAGE Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151 and ASTM D6319. The proposed device is non-sterile and powder free.

This document is primarily concerned with the 510(k) premarket notification for APOLLO ADVANTAGE Nitrile Examination Gloves, asserting its substantial equivalence to a predicate device. It details acceptance criteria and performance data for various physical and biocompatibility characteristics of the gloves.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document doesn't explicitly state specific sample sizes for each test. Instead, it refers to compliance with established ASTM and ISO standards for medical devices and biocompatibility. These standards typically define acceptable sampling plans. The data provenance is not explicitly mentioned, but given the manufacturer (Dell Corning Corporation) with an address in South Carolina, USA, and an Asia Co., Ltd in Wuhan, China, and the nature of the tests, it's likely conducted in a controlled laboratory setting by or for the manufacturer. The tests are non-clinical (laboratory-based) rather than retrospective or prospective patient studies.

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 a way that is applicable to human expert review. For these types of device performance tests (physical properties, watertightness, powder content, biocompatibility), the "ground truth" is established by the specifications and methodologies outlined in the referenced international standards (ASTM and ISO). The testing would be performed by qualified laboratory personnel following these validated procedures, not typically by human experts reviewing results for subjective interpretation.

4. Adjudication method for the test set:

Not applicable in the context of this type of device testing. The results are quantitative measurements against objective criteria defined by the standards. There is no subjective interpretation requiring adjudication among experts.

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 medical device clearance for examination gloves, not an AI-assisted diagnostic or imaging device. There are no "human readers" or AI assistance involved.

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

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

7. The type of ground truth used:

The ground truth for these tests is based on established international and national standards and specifications:

• ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
• ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)

The device's performance is compared against the quantified acceptance criteria outlined in these standards.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. There is no training set for this device.

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