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Powder Free Yellow Synthetic Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or linger to prevent comamination between patient and examiner.

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves":

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011)" and other relevant standards. The table re-iterates specific performance metrics where provided.

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

• The document does not explicitly state the sample sizes used for the testing of the subject's device for each of the listed criteria (e.g., how many gloves were tested for length, width, tensile strength, pinholes, etc.).
• The data provenance is not specified (e.g., country of origin of data). Given the manufacturer is from China, it's likely the testing was conducted there or by a lab associated with the manufacturer.
• The data is retrospective, as it refers to tests conducted on manufactured products to demonstrate compliance with existing standards.

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

• This information is not applicable to this type of device and study. The "ground truth" for patient examination gloves is established by adherence to engineering and material performance standards (e.g., ASTM, ISO), not by expert consensus on interpretations of medical images or conditions. The standards themselves define the acceptable performance parameters.

4. Adjudication method for the test set:

• This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies) to resolve disagreements among experts. Here, the assessment is based on objective measurements against predefined standards.

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices, often involving AI, where human readers interact with the device's output. The device in question is a patient examination glove, which does not involve human readers in the context of interpretation or diagnosis that would necessitate an MRMC study.

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

• No, a standalone performance study in the context of an "algorithm only" or "AI without human-in-the-loop" was not done. This device is not an algorithm or AI system. Its performance is assessed through physical and chemical testing against established standards.

7. The type of ground truth used:

• The ground truth used is based on established industry standards and regulatory requirements. Specifically:
  • ASTM Standard D 5250-06 (Reaffirmation 2011): Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This defines physical characteristics like dimensions, tensile strength, elongation, and freedom from holes.
  • ASTM D 5151-06 (Reaffirmation 2011): Standard Test Method for Detection of Holes in Medical Gloves. This specifies the water leak test for pinholes.
  • ASTM D 6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
  • 21 CFR 800.20: FDA regulation concerning medical gloves.
  • ISO 10993-10: 2002/Amd. 1:2006(E): Biocompatibility testing for irritation and sensitization.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of a medical device like a patient examination glove. Training sets are used in machine learning or AI algorithm development. The gloves are manufactured and then tested to ensure they meet specifications.

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

• This information is not applicable as there is no training set for this type of device.

Ask a specific question about this device

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.

Vinyl Examination Gloves, Powdered

This document is a 510(k) premarket notification for Vinyl Examination Gloves, Powdered. It is a clearance letter from the FDA. This type of document, particularly for a Class I device like examination gloves, does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the same way a software device submission would.

Medical gloves are considered a low-risk device and their substantial equivalence is primarily based on performance standards and material specifications, rather than complex clinical studies or AI algorithm performance.

Therefore, I cannot provide the requested information because it is not present in the provided document and is generally not applicable to the FDA clearance process for a device of this type.

Here’s why the requested information isn't available for this document:

• Acceptance Criteria & Device Performance: For gloves, the acceptance criteria are typically related to physical properties (tensile strength, elongation, freedom from holes) and chemical safety (biocompatibility). The document mentions the device but does not provide a table of these performance metrics.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are concepts primarily relevant to diagnostic algorithms, AI, or higher-risk devices requiring clinical trials, not basic medical devices like examination gloves. The document confirms substantial equivalence to a predicate device, which means direct comparative testing might have been done for certain physical properties, but not in the format of a "study" with AI or human readers.
• Ground Truth: For gloves, the "ground truth" would be objective measurements of their physical properties and sterility/biocompatibility, not an expert consensus on a diagnosis.
• Training Set: There is no "training set" for a physical device like a glove. This concept applies to machine learning algorithms.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence for a low-risk medical device (vinyl examination gloves). The detailed study information requested is not part of this type of submission for this particular device.

Ask a specific question about this device

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.

Synthetic Powder Free Vinyl Patient Exam Gloves

This document is a 510(k) premarket notification for a medical device: "Powdered Free Synthetic Vinyl Examination Glove," regulated under 21 CFR 880.6250 (Patient Examination Gloves). The FDA letter indicates that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory clearance letter, not a technical study report.

Therefore, I cannot fulfill your request for the detailed information outlined in points 1 through 9. The document only confirms the device's regulatory classification and that it can be marketed.

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