Search Results

The intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A Generator to separately cleared compatible RF devices.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "RFP-100A Connector Cable (Single Use)". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does not include information about acceptance criteria, performance studies, or ground truth establishment for an AI/ML device.

The device described, a connector cable, is a passive component used to connect two other cleared medical devices (a generator and RF devices). Its function is likely to transmit electrical signals, and its acceptance criteria would focus on electrical safety, biocompatibility, mechanical integrity, and compatibility with the specified devices, rather than the kind of performance metrics (sensitivity, specificity, AUC) typically associated with AI/ML-driven diagnostic or prognostic tools.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it is not relevant to the type of device being discussed.

To provide the information you've requested, I would need a 510(k) summary or a similar document for an AI/ML-enabled medical device that performs a diagnostic, prognostic, or therapeutic function.

Ask a specific question about this device