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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 WITH ALOE VERA, GREEN COLOR

I am sorry, but the provided text is a 510(k) clearance letter for "Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color." This document does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML medical device.

The letter discusses the substantial equivalence of the gloves to a legally marketed predicate device and the general regulatory requirements for such a device. There is no mention of an algorithm, AI, machine learning, or any performance study related to such a system.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from this document.

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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

The provided text is a 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Synthetic Exam Gloves." This type of document from the FDA relates to the regulatory clearance of a medical device based on substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria in the way an AI/ML algorithm would.

Therefore, the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, MRMC study, etc.) is not applicable to this document.

Here's why and what information can be extracted:

• Acceptance Criteria & Device Performance: The approval is based on "substantial equivalence" to a legally marketed predicate device. This means the FDA determined the new device is as safe and effective as a previously cleared device. There aren't explicit performance metrics or acceptance criteria stated in a quantitative table for this type of device in this document. Instead, the device is expected to meet general controls and standards applicable to patient examination gloves.
• Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): These concepts are relevant to the validation of AI/ML algorithms, clinical trials, or performance studies that assess diagnostic accuracy, sensitivity, specificity, etc. A premarket notification for disposable exam gloves does not typically involve such studies described in the context you've provided. The "study" for this device would have involved demonstrating compliance with relevant standards (e.g., for barrier integrity, biocompatibility, dimensions, strength), commonly through laboratory testing, not clinical trials with human readers or AI.
• Training Set & Ground Truth for Training: Again, not applicable. This device is a physical product (gloves), not an AI algorithm requiring a training set.

In summary, the provided document does not contain the information needed to answer your questions because it concerns the regulatory clearance of a physical medical device (gloves) under the 510(k) pathway, which is distinct from the validation process of an AI/ML diagnostic or assistive device.

Ask a specific question about this device

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

I'm sorry, but your query cannot be fulfilled. The document provided is an FDA 510(k) clearance letter for a medical device (Disposable Powder Free Vinyl Synthetic Exam Gloves). It confirms that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain any information about the acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be necessary to answer your specific questions. These details are typically found in the actual 510(k) submission, not in the clearance letter itself.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device