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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN, YELLOW GOLD COLOR

This document is a 510(k) clearance letter from the FDA for a medical device: "Ennoble Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin, Yellow Gold Color."

This type of document (510(k) clearance) does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device specifications, materials, and performance standards to the predicate. The FDA letter confirms this substantial equivalence has been met, but it does not delve into the specific studies and data you're requesting that would typically be found in a clinical study report or a more detailed technical submission.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical study demonstrating device performance against specific acceptance criteria.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES

Based on the provided text, the device in question is "Disposable Powder Free Vinyl Synthetic Exam Gloves." The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a detailed study with specific acceptance criteria and performance metrics typically found for more complex medical devices like AI algorithms.

Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria cannot be directly extracted from this document, as it doesn't pertain to an AI/software device. However, I can infer some "acceptance criteria" from the nature of the device and the FDA's declaration of substantial equivalence.

Here's an attempt to answer the questions based on the available information and general understanding of medical device regulation for such products:

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

Since this is a Class I device (Patient Examination Glove), the "acceptance criteria" are implied by the regulatory framework for patient examination gloves and the predicate device. These typically relate to physical properties and barrier integrity. The document does not provide specific numerical performance metrics from a study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document does not specify a sample size for a test set or data provenance for a study. For a glove, testing typically involves batches of gloves to ensure quality and compliance with standards. It would be prospective testing on manufactured products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to this type of device. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic devices interpreting medical images or data. For a patient examination glove, "ground truth" relates to physical and material property measurements.

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

Not applicable. This concept is for diagnostic interpretation, not for evaluating the physical properties of a glove.

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 concept is for diagnostic AI devices, not for patient examination gloves.

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

Not applicable. This concept is for AI algorithms, not for patient examination gloves.

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

For patient examination gloves, the "ground truth" for performance would be based on objective physical and chemical tests conducted in laboratories (e.g., tensile testing machines, water leak test for pinholes, chemical analysis for leachables).

8. The sample size for the training set

Not applicable to this type of device and submission. This is relevant for machine learning models.

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

Not applicable, as there is no "training set" in the context of an AI model for this device. The manufacturing process and quality control would be based on established material science and engineering principles for glove production.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES

{"text": "The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Examination Gloves." This document primarily addresses the regulatory approval of a medical device and its intended use. It does not contain information about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in technical reports for AI/device performance. \n\nTherefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document is a regulatory approval letter, not a device performance study report."}

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDERED VINYL EXAM GLOVES

The provided text is a 510(k) premarket notification approval letter for "Disposable Powdered Vinyl Examination Gloves". This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. Therefore, I cannot generate the requested table and study details.

The document is a regulatory approval for a medical device and focuses on its substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics and studies that would be associated with an AI/ML product.

Ask a specific question about this device