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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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A Powdered 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.

Powdered Vinyl Examination Glove

The provided document is an FDA 510(k) clearance letter for a "Powdered Vinyl Examination Glove." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment related to a specific performance study.

Therefore, I cannot provide the requested information. The letter only states the device's classification, regulation details, and confirms substantial equivalence, which is a regulatory determination, not a performance study report.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Powdered Vinyl Examination Gloves

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for Powdered Vinyl Examination Gloves, which confirms the device's substantial equivalence to a predicate device.

The clearance letter does not contain details about:

• Specific acceptance criteria for device performance (e.g., tensile strength, tear resistance, barrier integrity).
• Details of a study that proves the device meets any specific acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance, number or qualifications of experts, or adjudication methods.
• Any multi-reader, multi-case comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used or how it was established.

This document focuses on regulatory clearance based on substantial equivalence, not on a detailed technical performance study.

Ask a specific question about this device

Powdered Vinyl Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

Powdered Vinyl Examination Gloves

The provided text describes a 510(k) premarket notification for "Powdered Vinyl Examination Gloves." This document is a regulatory approval letter from the FDA. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/software devices.

The FDA 510(k) clearance process demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study in the way AI devices are evaluated.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document. This document pertains to a medical device (examination gloves), not an AI or software device that would typically undergo the types of studies inquiring about.

Ask a specific question about this device