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

Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Pre-powdered)

The provided text describes the specifications and quality control scheme for vinyl patient examination gloves, rather than a medical device with an algorithm or AI component requiring a study to prove acceptance criteria in the typical sense of AI/ML devices. Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.

However, I can extract the acceptance criteria and the methods used to show the device meets those criteria based on the provided information, which primarily references ASTM and ISO standards for physical characteristics and manufacturing quality.

Here's a summary tailored to the provided document:

Acceptance Criteria and Device Performance for Vinyl Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines acceptance criteria based on two main sections:

• "SPECIFICATION OF VINYL GLOVES (Ambidextrous)" (Page 2) which lists specific physical dimensions and performance requirements. This section appears to be the target specification for the gloves.
• "PERFORMANCE REQUIREMENTS FOR QUALITY CHARACTERISTICS" AND "QUALITY CHARACTERISTICS" (Pages 5-6) which detail the quality control parameters and their associated Assurance Actions and AQLs (Acceptable Quality Levels). This section describes how the product is monitored and accepted during manufacturing.

Table 1: Acceptance Criteria and Reported Device Performance (Summary from Specifications and Quality Control)

The conclusion states: "The vinyl Patient Examination gloves (Pre-powdered) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 Standard and meet pinhole requirements and labeling claims." This is the direct statement of performance against the acceptance criteria.

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

• Sample Size: The document refers to sampling procedures in accordance with ISO 2859 ("Sampling procedures and Tables for Inspection by Attributes"). It also mentions "median of not less than three measurements" for thickness (A.1), "median of at least 10 results" for residual powder (A.3), and "median of not less than 5 test results" for physical requirements (A.4). However, specific numerical sample sizes for the overall test set (e.g., number of gloves tested for full compliance) are not explicitly stated. The AQL (Acceptable Quality Level) values (e.g., 2.5, 1.0, 1.5, 4.0) and Inspection Levels (e.g., S-2, II, 1) refer to the statistical sampling plans within ISO 2859 and US FDA Test Methods, which would dictate the sample sizes based on lot size, but these specific numbers are not provided.
• Data Provenance: Not applicable in the context of an "AI device." The testing would be performed on manufactured batches of physical gloves at the manufacturing site (Evergreen Medical Products (Jingxing) Co., Ltd.) in China, as part of their quality control process. The biocompatibility testing was "Issued by Consumer Products Testing Co."

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

• Not applicable as this is a physical product (gloves) and not an AI/ML device relying on expert-labeled data. Ground truth here refers to adherence to objective physical and chemical standards.

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

• Not applicable for the reasons stated above. Testing involves measuring characteristics against predefined physical/chemical limits. Visual inspection for defects ("Visual, Sensual" in Section 22.0) would follow established quality control protocols, but not multi-expert adjudication in the AI sense.

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 not an AI device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• The "ground truth" for the device's performance is adherence to established international and national standards for medical gloves:
  • ASTM Specification D 5250-99 (Standard Specification for Vinyl Examination Gloves for Medical Application) for general glove properties.
  • JIS-S-2045.509/5.9/5.2 for specific dimensions and mechanical tests.
  • ISO 2859 for sampling procedures.
  • US FDA Test Method for Leakage Defects as published in the Federal Registration of Nov. 31, 1989 (21 CFR Part 800.20) for pinholes.
  • ASTM D 3578 (Standard Specification for Rubber Examination Gloves) for physical requirements (aging).
  • BS 4005 (Single Use Sterile Surgical Rubber Gloves, Appendix C) for air inflation and cuff test (partial adherence).
  • Biocompatibility testing results (Primary Dermal Irritation in Rabbits, Guinea Pig Sensitization) for safety.
  • Chemical composition (Polyvinyl Chloride, Plasticizers, etc.) against specified percentages.
  • Manufacturing Practice: Compliance with current Good Manufacturing Practice (GMP) requirements.

8. The sample size for the training set:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

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

Vinyl Patient Examination Gloves- Pre-powdered

I am sorry, but the provided text is a letter from the FDA regarding the clearance of Vinyl Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance for the product. Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study as the necessary information is not present in the given document.

Ask a specific question about this device