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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 Acist 4 French Angiographic Catheter is intended for use to deliver radiopaque contrast medium to selected sites in the vasculature.

The Acist 4 French Angiographic Catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system.

It is a single-lumen catheter manufactured primarily from a radiopaque plastic tube that has an encapsulated stainless steel wire braid to provide strength for injection pressures up to 1200 psi / 8275 kPa. The proximal end of the device incorporates a strain relief with a female plastic Luer hub for injection to the injection source. The stem and tip sections are radiopague and are permanently formed to a variety of shapes to facilitate use in various parts of the patient's vasculature. The non-tapered soft distal tip has end and angled multiple side-holes to balance the injection force and stabilize tip position.

The device is packaged in a Tyvek-to-poly pouch, sterilized by a validated Ethylene Oxide sterilization cycle, and sold for single use only within a 24-month shelf life.

The provided text focuses on the 510(k) summary and FDA clearance letter for the Acist 4 French Angiographic Catheter. It outlines the device's description, intended use, classification, and predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested table or details about a study for this specific device based on the given input. The document is primarily a regulatory filing and approval, not a scientific study report.

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