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Shelly Protected Fistula Needle is part of the hemodialysis system that connects patients to the machine and provides access to patient's blood, It is also used in plasmapheresis for the same purpose. Shelly Protected Fistula Needle has a shield that when activated enclose the needle. This mechanism is intended to reduce the incidence of accidental needlesticks.

Shelly Protected Fistula Needle has a shield that when activated enclose the needle.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Shelly Protected AV Fistula Needle Set." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device. The letter is a regulatory approval, not a scientific or clinical study report. Therefore, I cannot extract the requested information.

The document primarily focuses on:

• Device Identification: Shelly Protected AV Fistula Needle Set
• Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a predicate device.
• Indications for Use: Describing the device's purpose in hemodialysis and plasmapheresis, and its safety mechanism for preventing needlesticks.
• Regulatory Compliance: Mentioning general controls and good manufacturing practices.

There is no mention of:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Any performance study results (e.g., test set sample size, data provenance, expert ground truth, adjudication methods).
• AI/ML components or comparative effectiveness studies with human readers.
• Training set details.

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Fistula needle is part of the Hemodialysis system that provides access to the patient's blood. It is also used in plasmapheresis for the same purpose.

Shelly AV Fistula Needle

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Shelly AV Fistula Needle) and an "Indications for Use" statement.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study details you've requested.

The letter is a regulatory document indicating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include the technical study data you're looking for.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or any of the other study-related information based on the text provided.

Ask a specific question about this device