(156 days)
The SOUNDSTAR™ CRYSTAL Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO™ 3 EP Navigation Systems, the catheter provides location information. Refer to the Compatibility Matrix Insert for compatible CARTO™ 3 Systems as each catheter is compatible with a specific version of the CARTO™ 3 System and is not backward compatible with previous versions of the CARTO™ 3 EP Navigation System.
The SOUNDSTAR CRYSTAL Ultrasound catheter is disposable and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheter is to be used only on systems with which they have been tested and found compatible. The proposed device, when connected to the corresponding Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO® 3 EP Navigation System.
The provided text is a 510(k) premarket notification for the SOUNDSTAR™ CRYSTAL Ultrasound Catheter. It does not describe a study involving acceptance criteria and device performance in the context of AI/algorithm performance.
The document states: "The SOUNDSTAR™ CRYSTAL Ultrasound catheter in this submission uses the same intended use, technology and principles as the predicate device and hence clinical data is not required to establish substantial equivalence." This indicates that the regulatory submission primarily relies on demonstrating equivalence to a previously cleared device through non-clinical testing, rather than presenting a study proving performance against specific acceptance criteria with human or AI assessment.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study (especially a clinical or AI-centric one) is not included in this submission. The "Performance Testing" section lists various engineering and safety standards (e.g., ISO, ANSI/AAMI, IEC) that the device complies with, but these are not presented as acceptance criteria for performance in the way described in your prompt (e.g., sensitivity, specificity, or human reader improvement with AI).
If you have a different document that details a clinical study or AI algorithm performance, I would be happy to analyze that.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).