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A Powder Free Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Vinyl Examination Gloves

I regret that I cannot fulfill your request to describe the acceptance criteria and study for a medical device based on the provided text. The document you've shared is an FDA 510(k) clearance letter for "Powder Free Vinyl Examination Glove" (K122377).

This type of document primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device. It does not typically contain the detailed information about acceptance criteria, the specific studies performed to prove the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment that you've requested.

The FDA 510(k) clearance process for Class I devices like examination gloves often relies on demonstrating equivalence to existing devices rather than requiring extensive de novo clinical trials with detailed performance metrics and statistical analyses as might be seen for higher-risk devices or novel technologies.

Therefore, the information necessary to answer your specific questions (e.g., a table of acceptance criteria and performance, sample sizes for test/training sets, details on expert ground truth, MRMC studies, standalone performance) is not available within these pages.

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A Powdered Viny! Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powdered Vinyl Examination Gloves

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powdered Vinyl Examination Glove":

Important Note: The provided document is a 510(k) clearance letter from the FDA for a medical device (Powdered Vinyl Examination Glove). It is NOT a detailed study report. Therefore, much of the information typically found in a study report, such as specific sample sizes for training/test sets, details about ground truth establishment, or expert qualifications, will not be present in this type of document. This letter primarily confirms that the device is "substantially equivalent" to predicate devices, meaning it meets existing standards and specifications.

Based on the nature of this document and the product (examination gloves), the acceptance criteria are generally based on physical performance standards rather than diagnostic performance metrics for an AI/algorithm-driven device.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an examination glove, the "performance" is related to its physical properties and barrier integrity, not diagnostic accuracy. The FDA clearance implies that the device meets the applicable standards, which would include criteria like those in ASTM D5250 for vinyl examination gloves.

Note: The 510(k) letter itself does not explicitly list these criteria or detailed results. It states that the device is "substantially equivalent" to predicate devices, which means it has been demonstrated to perform as safely and effectively as legally marketed devices under similar specifications and standards. The underlying testing would have been conducted by the manufacturer to demonstrate compliance with these standards.

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

• Sample Size: Not specified in the 510(k) letter. For physical testing of gloves, sample sizes are dictated by relevant ASTM/ISO standards (e.g., ANSI/ASQ Z1.4 for AQL sampling). This would typically involve taking samples from production lots (e.g., 200 gloves per lot for a specific AQL level) over a period to demonstrate consistency.
• Data Provenance: The manufacturer, Shu Tong Xinghua Company, Limited (China), would have conducted the tests. The data would be prospective in the sense that the testing is performed on manufactured lots of the device.

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

• This question is not applicable in the context of an examination glove's functional performance where "ground truth" refers to diagnostic accuracy. The "ground truth" for glove testing is derived from standardized laboratory measurements (e.g., water leak tests for pinholes, mechanical testers for tensile strength).
• The "experts" involved would be qualified laboratory technicians and quality control personnel, trained in performing the specific ASTM/ISO tests. Their qualifications would involve training in laboratory procedures, quality assurance, and potentially relevant engineering or scientific degrees.

4. Adjudication Method for the Test Set:

• Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., medical image reading) where disagreement among experts might occur. Glove testing involves objective physical measurements that have established pass/fail 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:

• Not applicable. This device is a physical product (examination glove), not an AI-driven diagnostic or interpretative system. Therefore, no MRMC study, AI assistance, or human reader improvement metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a physical product, not an algorithm, so "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• The "ground truth" for examination gloves is based on objective physical and chemical measurements against established national and international standards (e.g., ASTM D5250, D6319 for synthetic gloves, ISO 10993 for biocompatibility). Examples include:
  • Direct measurement: Glove dimensions (length, width, thickness).
  • Water leak test: For detection of pinholes.
  • Mechanical testing: Tensile strength and elongation at break.
  • Chemical analysis: For material composition and potential leachables.
  • Biocompatibility testing: In-vitro and/or in-vivo tests for irritation and sensitization.

8. The Sample Size for the Training Set:

• Not applicable in the AI sense. For manufactured goods, the "training set" could be loosely analogous to the data collected during product development and early manufacturing runs to refine the production process and ensure consistency. However, sample sizes for such internal validation are not typically disclosed in 510(k) clearances and are part of the manufacturer's internal quality system documentation.

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

• Not applicable in the AI sense. Ground truth for manufacturing processes is established through adherence to engineering specifications, material standards, and quality control procedures. Any "training" of a manufacturing process would involve iterative testing and refinement based on the measurable outcomes of the physical tests mentioned in point 7.

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