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A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-10.

The provided document describes the acceptance criteria and performance of Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves. However, it does not describe an AI device or a study involving AI. Therefore, I cannot provide information related to AI-specific aspects like training sets, ground truth for training sets, MRMC studies, or standalone algorithm performance.

The document details the device's adherence to established standards for medical examination gloves to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA.

Here's the information based on the provided text, focusing on the device's performance against its acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study described is a non-clinical performance evaluation comparing the subject device (Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves) to a predicate device (Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue) and against recognized industry standards. The purpose is to demonstrate "Substantial Equivalence" as required for FDA 510(k) clearance.

The study involved testing the physical properties, dimensions, freedom from pinholes, residual powder, and biocompatibility of the subject device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for tensile strength, pinholes, etc.). It only states that the device "Meets" the specified ASTM standards.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, beyond the manufacturing location of Hongye Plastic Products Co., Ltd. being in Hebei, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The "ground truth" for examination gloves is adherence to measurable physical and biological standards (e.g., tensile strength, dimensions, biocompatibility), which are typically assessed through standardized laboratory testing, not expert consensus.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments or when multiple human readers are involved in clinical studies. For physical property testing of gloves, objective measurements against a standard are performed.

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 information is not applicable. This document describes a medical device (examination gloves), not an AI system or an imaging diagnostic tool where MRMC studies would be relevant.

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

This information is not applicable. The device is a physical product (gloves) and does not involve an algorithm or AI.

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

The "ground truth" for this device is based on objective, measurable criteria established by recognized industry standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves), ISO 10993 Part 10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization), and relevant CFR regulations (e.g., 16CFR 1500.41, 16CFR 1500.3 for flammability and irritation).

8. The sample size for the training set

This information is not applicable as this is not an AI device.

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

This information is not applicable as this is not an AI device, and therefore no training set or its associated ground truth was established.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (Reapproved 2005).

The acceptance criteria for the Hongye Plastic Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue, are based on adherence to ASTM standard D-6319-00a (Reapproved 2005) and FDA requirements for patient examination gloves.

Here's a breakdown of the acceptance criteria and performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • For physical and dimensions testing, the inspection level was S-2, AQL 4.0. This indicates a sampling plan, but the exact number of gloves tested is not explicitly stated as a raw number. AQL (Acceptable Quality Limit) 4.0 refers to the maximum percentage of defective items that, for purpose of sampling inspection, can be considered satisfactory.
  • For the FDA 1000 ml. Water Fill Test, the inspection level was G-1, AQL 2.5. Again, this is a sampling plan, not a raw number.
  • For Biocompatibility (Primary Skin Irritation and Skin Sensitization) and the Residual Powder Test, specific sample sizes are not explicitly stated in the provided text.
• Data Provenance: The document does not explicitly state the country of origin of the data beyond the manufacturer being in China. The study appears to be retrospective in the sense that it's a report of tests conducted on manufactured gloves to demonstrate compliance with standards. It's not a prospective clinical trial.

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

This section is not applicable to this device. The "ground truth" for examination gloves is established by objective performance against predefined technical standards (ASTM, FDA water fill test, biocompatibility protocols) rather than expert consensus on diagnostic images or clinical outcomes. The tests described are standardized laboratory and physical property tests.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., radiologists reviewing images) to resolve discrepancies. For objective tests on examination gloves, the results are quantitative measures or pass/fail criteria based on defined thresholds.

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 medical glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating AI performance in clinical diagnostic scenarios.

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

This is not applicable. This device is a medical glove, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective technical standards and laboratory test results. This includes:

• Physical property measurements (e.g., dimensions, tensile strength, elongation, force at break) against ASTM D-6319-00a specifications.
• Absence of holes (pinholes) as determined by the FDA 1000 ml Water Fill Test.
• Biocompatibility (absence of primary skin irritation and sensitization) as determined by standardized in-vivo or in-vitro tests (methods not detailed beyond "testing conducted with results showing no primary skin irritant or sensitization reactions").
• Residual powder levels determined by ASTM D-6124-01.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI model. Its performance is demonstrated through adherence to established manufacturing and testing standards.

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

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

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