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The Faller stylet is a surgical tool used to create a subcutaneous tunnel for a peritoneal dialysis catheter, from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.

Faller Stylet

This document is an FDA 510(k) clearance letter for the "Faller Stylet," a surgical tool used to create a subcutaneous tunnel for peritoneal dialysis catheters. As such, it does not contain the kind of detailed performance study information, acceptance criteria, or clinical trial data you are requesting for an AI/ML device.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, expert adjudication, MRMC studies, and standalone performance) are highly relevant for the evaluation of AI/ML-based medical devices. These types of devices require rigorous testing against predefined performance metrics, typically involving clinical validation studies.

This document is for a mechanical surgical tool. Its clearance is based on substantial equivalence to predicate devices, which generally means demonstrating that it has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed devices, without introducing new risks or questions of effectiveness. This usually involves:

• Bench testing: To confirm physical properties, strength, etc.
• Biocompatibility testing: To ensure materials are safe for human contact.
• Sterilization validation: To ensure the device can be properly sterilized.
• Performance testing: To confirm it performs its intended mechanical function (e.g., smoothly separates tissue).

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training, expert details, adjudication, MRMC, standalone performance, ground truth types) from this specific document because it pertains to a different type of medical device and regulatory pathway.

Ask a specific question about this device