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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

The provided text is an FDA 510(k) summary for "Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific clinical efficacy or diagnostic accuracy criteria as would be required for a novel AI/imaging device.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, effect size, type of ground truth) are not applicable to this type of medical device submission. This submission relies on established performance standards for examination gloves.

Here's how the available information from the document applies to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document compares the subject device's performance against established ASTM standards and FDA requirements, as well as against the predicate device.

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for pinholes, dimensions, etc.). However, it refers to "Inspection Level ILS-2 AQL 4.0" and "Inspection Level IAQL2.5" which are statistical sampling plans used in quality control (Acceptable Quality Levels). While these indicate a sampling methodology, the precise number of units sampled for each test is not explicitly stated.
• Data Provenance: The tests were performed on the subject device manufactured by Anhui Kindguard Medical Supplies Technology Co.,Ltd, located in China. The data would be derived from the manufacturing and quality control processes of the subject device. These are prospective tests performed on newly manufactured devices for the purpose of the 510(k) submission.

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

• Not Applicable. For this type of device (patient examination gloves), "ground truth" is established through adherence to physical and chemical performance standards (e.g., ASTM standards for dimensions, tensile strength, freedom from pinholes, biocompatibility). These are objective measurements and laboratory tests, not subjective interpretations requiring multiple human experts.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods are typically relevant for subjective assessments (e.g., image interpretation where disagreements among readers need resolution). This submission relies on objective physical and chemical 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:

• Not Applicable. This is not an AI or imaging device. It's a physical medical device (examination gloves). Clinical performance data (including MRMC studies) was explicitly stated as not needed to demonstrate substantial equivalence, and "determination of substantial equivalence is not based on an assessment of clinical performance data."

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

• Not Applicable. This is not an algorithm based device.

7. The type of ground truth used:

• The "ground truth" here is defined by established consensus standards and regulatory requirements for patient examination gloves, specifically:
  • ASTM D5250-06 (Reapproved 2011) - Standard Specification for Poly(vinyl chloride) Patient Examination Gloves
  • ASTM D5151-06 (Reapproved 2011) - Standard Test Method for Detection of Holes in Medical Gloves
  • ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
  • 21 CFR 800.20 - Tests for leakage of medical devices
  • ISO 10993-10: 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
• The device's performance is objectively measured against the specifications outlined in these standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning or AI algorithm. The manufacturing process and quality control adhere to established standards, where the "training" analogous concept would be the development and adherence to manufacturing specifications and test methods.

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

• Not Applicable. As there's no training set, this question is not relevant. The "ground truth" for ensuring consistent product quality is embedded in the standardized manufacturing processes and quality control testing that align with the aforementioned ASTM and ISO standards.

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Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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.

PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

The provided document describes a 510(k) premarket notification for Kindguard Powder Free Vinyl Patient Examination Gloves. This is a Class I medical device, and the evaluation for substantial equivalence primarily relies on non-clinical performance data and comparison to a predicate device, rather than a study involving an AI algorithm or human readers.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets those criteria (especially those related to AI, human readers, ground truth establishment, sample sizes for training/test sets, and expert adjudication) are not applicable to this type of device and submission.

However, I can extract the relevant information regarding the acceptance criteria and the performance of this specific device based on the provided text.

Here's a breakdown of the requested information, with NA (Not Applicable) for elements not relevant to this submission type:

Acceptance Criteria and Device Performance for Kindguard Powder Free Vinyl Patient Examination Gloves

This submission is for a Class I medical device (patient examination gloves), which does not involve an AI algorithm or complex human interpretation tasks. Thus, the "study" proving acceptance is primarily a set of non-clinical performance tests and a comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Testing: The specific number of gloves tested for each characteristic is not explicitly stated in this summary. However, tests were conducted according to the relevant ASTM and ISO standards, which define the required sample sizes for quality control and batch testing (e.g., AQL levels for pinholes).
• Data Provenance: The device manufacturer, Anhui Kindguard Medical Supplies Technology Co.,Ltd, is based in China. The testing would have been performed by or for the manufacturer. The data is based on prospective testing of the manufactured product to demonstrate compliance with standards.

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

• NA. For this type of device (patient examination gloves), "ground truth" is established through standardized physical, chemical, and biological tests (e.g., measuring tensile strength, water leak tests, biocompatibility assays) according to international standards (ASTM, ISO). There is no "expert consensus" on image interpretation or diagnostic performance in the traditional sense. The "experts" would be the qualified personnel performing these laboratory tests.

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

• NA. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments, particularly in medical imaging where multiple readers interpret cases. This is not applicable to the objective physical and chemical testing of medical gloves.

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:

• NA. This device does not involve AI or human readers for diagnostic purposes.

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

• NA. This device does not use an algorithm.

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

• The "ground truth" for this device is based on objective, standardized measurements and laboratory test results performed according to specified ASTM and ISO standards (e.g., ASTM D5250 for dimensions and physical properties, ASTM D5151 for freedom from pinholes, D6124 for powder residual, ISO 10993-10 for biocompatibility). These standards define the acceptable range or pass/fail criteria.

8. The sample size for the training set:

• NA. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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

• NA. See point 8.

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