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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.

Powder Free Vinyl Patient Examination Glove (Non-Sterile) is a patient examination glove available in S, M, L, XL. The glove is provided non-sterile and meets the entire requirement of ASTM standard D 5250-06.

The provided text is a 510(k) premarket notification for a medical device: "Powder Free Vinyl Patient Examination Glove (Non-Sterile)". The document outlines the device description, intended use, and a comparison to a predicate device.

However, the information requested in the prompt, specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is presented in a different context than typically found in AI/ML performance studies. This document pertains to the regulatory clearance of a physical medical device (examination gloves), not an algorithmic or AI-powered one.

Therefore, many of the requested fields are not applicable in this context. I will extract the relevant information regarding performance criteria and how the device meets them from the provided text.

Here's the breakdown of the acceptance criteria and the supporting information:

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

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

• Sample Size for Test Set:
  • For "Freedom from pinholes," the sample size is explicitly stated as 32.
  • For other physical and material properties (dimension, tensile strength, elongation, powder residual), the sample sizes are not specified in the provided text, but it's implied that testing was conducted according to the respective ASTM standards.
  • For biocompatibility tests, the sample sizes for animal tests (rabbits, guinea pigs) are not specified.
• Data Provenance: The testing was conducted by or for LPL (HUI ZHOU) GLOVE CO., LTD in China, as stated by their address in the submitter information. The text does not specify whether the data is retrospective or prospective, but testing for regulatory submission typically involves prospective testing of manufacturing lots.

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

This question is not applicable to the evaluation of a physical medical device like examination gloves. "Ground truth" and "experts" in this context don't align with the AI/ML paradigm. The acceptance criteria are based on established international standards (ASTM, ISO) for physical and material properties and biological safety. Compliance is measured quantitatively.

4. Adjudication method for the test set

Not applicable. The evaluation is against objective, quantitative standards (e.g., specific dimensions, tensile strength values, AQL levels). There's no human "adjudication" in the sense of reconciling differing expert opinions.

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 physical medical device, not an AI or imaging diagnostic tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is defined by:

• International Standards: Specifically, ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM 5151-06 (likely D5151, Standard Test Method for Detection of Holes in Medical Gloves).
• Biocompatibility Standards: ISO 10993-5: 2009 (Cytotoxicity), ISO 10993-10: 2010 (Irritation and Skin Sensitization), and the general framework of ISO 10993-1.

These standards provide the quantitative and qualitative benchmarks against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model 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 type of device.

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The powder free vinyl patient examination glove (non-sterile) 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. It is sold as non-sterile.

Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06, except for sterility requirements.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves (Non-Sterile):

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set for each characteristic. It refers to meeting ASTM standards (D 5250-06, D5151-06, D6124-06) for physical properties, dimensions, freedom from pinholes, and powder residual. These standards typically define sampling plans and test methods.

For biocompatibility testing:

• Primary Dermal Irritation in Rabbits (ISO): The number of rabbits used is not explicitly stated, but ISO standards for dermal irritation typically involve a small number of animals (e.g., 3 rabbits).
• Guinea Pig Closed Patch Sensitization Test (ISO): The number of guinea pigs used is not explicitly stated, but ISO standards for sensitization testing typically involve a defined number of animals (e.g., 10-20 guinea pigs for the induction phase and a similar number for the challenge phase).

Data Provenance: The studies were conducted by the applicant, LPL (Hui Zhou) Glove Co., Ltd. The country of origin for the data is implied to be China, where the company is located. The studies are prospective as they were conducted to demonstrate the performance of the applicant's device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device (patient examination gloves) does not involve a diagnostic algorithm requiring expert-established ground truth. The evaluation relies on standardized physical, chemical, and biological testing.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication was performed as the evaluation is based on objective measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is a physical product (gloves) and does not involve AI or human interpretation of cases. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth for the performance evaluations (Dimensions, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility) is based on established industry standards and regulatory requirements. Specifically:

• ASTM Standards: ASTM D 5250-06, ASTM D5151-06, ASTM D6124-06. These standards define the test methods, acceptance limits, and sampling plans for the respective characteristics.
• Regulatory Standard: 21 CFR 800.20 (for freedom from pinholes, as referenced for the predicate device).
• ISO Standards: For biocompatibility testing (Primary Dermal Irritation and Guinea Pig Closed Patch Sensitization Test), implying adherence to ISO biological evaluation standards.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. (See #8)

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