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The modified device has the same intended use as that of the FDA-cleared (unmodified) device, which is as follows: "The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study."

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This document is a 510(k) clearance letter from the FDA for a medical device (EP Diagnostic Catheters). It does not contain the kind of information requested in the prompt regarding acceptance criteria and performance studies for an AI/ML powered device. The letter focuses on the substantial equivalence of the device to a predicate device, regulatory classifications, and general compliance requirements.

Therefore, I cannot extract the information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information is usually found in detailed clinical study reports or summaries submitted as part of the 510(k) application, which are not provided here.

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The Catheter is intended for use in electrogram recording and cardiac stimulation during diagnostic electrophysiology study.

6-French 20-Electrode Electrophysiology Diagnostic Catheter

The provided text is a 510(k) clearance letter from the FDA for a medical device. This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

The letter simply states that the FDA has reviewed the 510(k) notification for the "6-French 20-Electrode Electrophysiology Diagnostic Catheter" and determined it to be substantially equivalent to legally marketed predicate devices for its intended use (electrogram recording and cardiac stimulation during diagnostic electrophysiology study).

To answer your questions, I would need access to the actual 510(k) submission document, which would include the performance testing data and clinical study reports.

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The device will be generally placed in the high right atrium, right ventricular apex, and His bundle, and in the coronary sinus of the cardiac anatomy, and be used for electrogram recording and cardiac stimulation during diagnostic electrophysiology study.

Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter

I apologize, but the provided text from the FDA 510(k) clearance letter for the Slim Cath-Dx™ Cardiac Electrophysiology Diagnostic Catheter does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

This document is a clearance letter, which states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. It outlines regulatory class, product codes, and general controls, but it does not detail the specific performance metrics, clinical study design, or results that demonstrate the device's efficacy or safety against pre-defined acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement based on the information given.

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