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A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potentially infectious and other contaminants.

A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material.

The provided document is a 510(k) premarket notification letter from the FDA for medical examination gloves. It is not a study report for an AI/ML device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to the content of this document.

The document states:

• Device Name: Emerald Medical, Inc. Syntheticare Powder-Free Vinyl Patient Examination Gloves
• Regulation Name: Patient Examination Gloves
• Regulatory Class: I
• Product Code: LYZ

This type of device (patient examination gloves) is a physical medical product, not a software or AI-driven diagnostic device. The FDA's decision is based on substantial equivalence to a legally marketed predicate device, rather than a clinical study demonstrating performance against specific acceptance criteria for an AI algorithm.

To answer your questions, I would need a different type of document, specifically a study report or clinical validation report for an AI/ML medical device.

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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.

Emerald Medical, Inc. Syntheticare Powdered Vinyl Patient Examination Gloves

The provided document is a 510(k) premarket notification letter from the FDA for a medical glove. It does not contain any information about acceptance criteria, device performance data, study designs (training or test sets), expert qualifications, ground truth establishment, or any AI/algorithm specific details.

Therefore, I cannot provide the requested information. The document pertains to a medical device approval that predates the common use of AI in medical diagnostics and does not include any performance data in the typical sense for such devices (e.g., sensitivity, specificity for classification tasks). It's a regulatory approval based on "substantial equivalence" to a predicate device.

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The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.

The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) summary for the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System, which focuses on establishing substantial equivalence to previously marketed predicate devices. It discusses the device's purpose and its similarity to existing systems but does not include:

• Acceptance criteria or reported device performance metrics.
• Details of any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
• Information about training sets.

Therefore, I cannot provide a response filling in the requested table and study details based on the given input.

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Ask a specific question about this device