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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 finger to prevent contamination between patient and examiner.

Powder Free Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Synthetic Examination Gloves White Color (Sensi-Pro)". It establishes the device's substantial equivalence to previously marketed devices and outlines regulatory compliance.

The document does not describe:

• Any acceptance criteria for device performance.
• Any study proving acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, or ground truth establishment.
• Any multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided input.

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A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Disposable Powder Free Vinyl Polyurethane Coated Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Examination Gloves" manufactured by Hong Huang Tang Industrial Company, Ltd. It determines the device is substantially equivalent to legally marketed predicate devices.

Based on the provided document, answering the requested questions is not possible.

Here's why:

• This is a 510(k) clearance letter for medical gloves, not an AI/software as a medical device (SaMD) study report. The document pertains to a physical medical device (gloves) and assesses its substantial equivalence to existing products, primarily based on material safety, manufacturing practices, and intended use as a barrier.
• The questions you've asked are specific to the evaluation of an AI or software-based medical device. They inquire about performance metrics (e.g., sensitivity, specificity), ground truth establishment, expert adjudication, multi-reader multi-case studies, and training/test set details, which are all relevant to the validation of AI algorithms.

Therefore, I cannot provide the information requested in your numbered list as the provided document does not contain any details about an AI device or its performance study.

The document merely states that the gloves "prevent contamination between healthcare personnel and patient" as their indication for use. No performance metrics, study designs, or data provenance related to an AI algorithm are present.

Ask a specific question about this device

Ask a specific question about this device