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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 a disposable device intended for medical purposes 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, Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.

Here's a breakdown of the acceptance criteria and study information for the SHANGHAI CHINASTAR CORP. Powder-free Vinyl Patient Examination Gloves, based on the provided text:

Important Note: This document describes a medical device, but it is not an AI/ML device. Therefore, many of the requested fields related to AI performance, ground truth, expert consensus, and training/test sets are Not Applicable (N/A) for this type of product. The acceptance criteria focus on physical properties, biocompatibility, and regulatory compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • For Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact number of units is not specified, but this AQL (Acceptable Quality Level) implies a sampling plan.
  • For FDA 1000 ml Water Fill Test: Inspection Level S-4, AQL 2.5. The exact number of units is not specified, but this AQL implies a sampling plan.
  • For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but clinical testing was conducted.
  • For USP Iodine Test: Not explicitly stated, but conducted on "finished inspection."
• Data Provenance: Not explicitly stated, but the manufacturing company is based in Shanghai, China, suggesting the testing was performed there or by associated labs. The testing is retrospective in the sense that it's performed on manufactured products to ensure quality and compliance.

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

• N/A. This is a non-AI device. Ground truth for a glove focuses on objective measurements and established standards (e.g., tensile strength, dimensional accuracy, water leak tests, chemical composition). Expert consensus, in the sense of clinical interpretation, is not relevant here.

4. Adjudication method for the test set

• N/A. As this is a non-AI device, there's no "adjudication" in the context of expert review for ambiguous cases. The testing involves standardized procedures and objective measurements that either meet or do not meet predefined criteria.

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

• N/A. This is a non-AI device. MRMC studies are not applicable.

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

• N/A. This is a non-AI device.

7. The type of ground truth used

• The "ground truth" for this device constitutes objective, measurable standards and specifications defined by regulatory bodies (FDA) and industry standards (ASTM D-5250-92). This includes:
  • Objective Measurements: Physical dimensions, tensile strength, elongation, force at break (implied by ASTM D-5250-92).
  • Pass/Fail Tests: Water leak test (FDA 1000 ml Water Fill Test), USP Iodine Test for starch, primary skin irritation, skin sensitization.
  • Chemical Analysis: Ensuring "powder-free" status and absence of sensitizing agents.

8. The sample size for the training set

• N/A. This is a non-AI device; there is no "training set."

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

• N/A. This is a non-AI device; there is no "training set."

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A glove 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 a disposable device intended for medical purposes 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, Pre-powder Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Here's an analysis of the provided text regarding acceptance criteria and study data:

This document is a 510(k) summary for pre-powdered vinyl examination gloves. Medical gloves, in general, are low-risk devices (Class I) and do not typically involve the complex AI/ML-driven analyses you're asking about. Therefore, many of your questions about AI study specifics (effect size of AI assistance, MRMC studies, training set details) are not applicable to this type of device and submission.

The "acceptance criteria" here refer to meeting established industry standards for the physical properties and safety of medical gloves, rather than performance metrics for an AI algorithm.

Acceptance Criteria and Reported Device Performance

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

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

• Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact sample size is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) and inspection level, which refers to a sampling plan from industry standards.
• FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4. The exact sample size is not explicitly stated but is determined by the AQL and inspection level.
• Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests is not explicitly stated in the summary.
• Data Provenance: Not specified, but generally, these tests would be conducted by the manufacturer's quality control or a third-party testing lab. The submission is from Shanghai Chinastar Corp. in Shanghai, China. The testing would have been done prior to the 1999 submission date. These are non-clinical, lab-based tests.

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

N/A. This is a medical device for general use (gloves), not an AI/ML diagnostic or predictive device requiring clinical expert interpretation to establish ground truth for its performance. The "ground truth" for glove performance is adherence to physical specifications and biocompatibility standards measured by laboratory methods.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting clinical data for devices where human interpretation of medical images or symptoms is central to establishing ground truth. This is not relevant for glove testing.

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

N/A. This is not an AI-assisted device.

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

N/A. This is not an AI algorithm.

7. The type of ground truth used

For this device, the "ground truth" is defined by:

• Standard Specifications: Adherence to ASTM D-5250-92 for physical properties (e.g., dimensions, tensile strength, elongation).
• Performance Tests: Results from the FDA 1000 ml. Water Fill Test for pinhole integrity.
• Biocompatibility Testing: Results from Primary Skin Irritation and Skin Sensitization tests.
• Regulatory Compliance: Conformance to FDA Good Manufacturing Practices (GMPs) and relevant 21 CFR regulations.

8. The sample size for the training set

N/A. There is no AI/ML model for this device that would require a training set. The device's characteristics are determined by manufacturing processes and raw materials, not by learning from data.

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

N/A. See above.

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