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A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

BLUE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE

This document is a 510(k) clearance letter from the FDA for a Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile. It is a regulatory clearance for a medical device and, as such, does not contain the type of information typically found in acceptance criteria or study results for AI/ML-based medical devices.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance: This document is not for an AI/ML device, so no such performance data is present.
2. Sample size used for the test set and the data provenance: Not applicable to a physical glove.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses the regulatory process for this type of Class I, reserved medical device, referencing general controls, good manufacturing practices, labeling requirements, and reporting of adverse events. It explicitly states the "Indications for Use" for the glove: "A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a description of the intended use of a physical product, not a software algorithm.

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A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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This document is a 510(k) clearance letter from the FDA for a medical device: Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile.

This type of device (patient examination gloves) does not typically involve complex algorithms or AI. Therefore, the typical performance metrics associated with AI/ML devices (like sensitivity, specificity, AUC, human reader studies, etc.) along with the specific ground truth establishment and training set details, are not relevant or applicable to this document. The FDA clearance for such devices is based on demonstrating substantial equivalence to a predicate device and complying with general controls.

The performance criteria for examination gloves generally revolve around physical properties and barrier integrity, usually assessed through standardized tests defined in specifications like ASTM standards.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to an AI/ML device. The provided document does not contain information on:

• A table of acceptance criteria and reported device performance related to AI/ML metrics.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth, training set size, or how ground truth was established for a training set (as these are unique to AI/ML device development).

The document is a regulatory approval letter, not a clinical study report or a technical performance evaluation report for an AI-powered diagnostic device.

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A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

BLACK NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON-STERILE

I am sorry, but the provided text is a letter from the FDA regarding the clearance of a medical device (Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile). It does not contain information about the acceptance criteria and study proving device performance as outlined in your request.

Therefore, I cannot extract the requested details such as:

1. Table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

WHITE NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE

This document is an FDA 510(k) clearance letter for a medical device: "White Nitrile Powder-Free Patient Examination Glove, Non Sterile." It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

The document is a clearance for a physical medical device (gloves), not an AI/ML algorithm. Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) for a study on an AI/ML device is not present in this text.

The information provided in the document pertains to:

• Device Name: White Nitrile Powder-Free Patient Examination Glove, Non Sterile
• Regulation Number: 21 CFR 880.6250 (Non-powdered patient examination glove)
• Regulatory Class: Class I, reserved
• Product Code: LZA
• Indications for Use: A disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Type of Use: Over-The-Counter Use

For physical medical devices like gloves, "acceptance criteria" and "device performance" are typically defined by international standards (e.g., ASTM, ISO) regarding physical properties (tensile strength, puncture resistance, barrier integrity) and biocompatibility, as well as sterility if applicable. The "study" that proves these are typically laboratory tests on batches of the product, not clinical studies involving "test sets," "ground truth experts," or "AI assistance" as would be relevant for software as a medical device.

Therefore, I cannot fulfill your request using the provided text because it describes the clearance of a physical medical device and lacks the specific details you've asked for regarding AI/ML device performance studies.

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