(28 days)
The Allura 3D-CA release 1 is intended to assist physicians when analyzing 2-Dimensional X-ray images by creating 3-Dimensional views from a pair of 2-Dimensional images created during rotational angiographic runs.
The Allura 3D-CA release 1 device contains an image processing computer loaded with 3D-CA application software. It is linked through a DICOM port to a Philips Cardio-Vascular X-ray system and is intended to be placed in the control room of the Angiographic suite. 3D Coronary Angiography refers to 3D scanning of the coronary arteries, employing a C-arm based X-ray system. 2D projections are generated during a rotational scan, in which the patient's heart is scanned over an angular range of ca. 100-120 degrees. The complexity of making a 3D image of the coronary arteries is mainly caused by motion of the heart. 3D-CA uses a cardiac modeling technique to obtain a still 3D model of the heart. Cardiac modeling allows the construction of a 3D surface model of a coronary segment, or multiple segments, from two 2D projection images.
The provided text from the 510(k) submission for the "Allura 3D-CA, release 1" device does not contain information about specific acceptance criteria or an explicit study proving the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (Integris 3D-RA release 4.2) and confirming compliance with general safety and effectiveness regulations, such as DICOM standards and UL safety standards.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
This submission is a premarket notification (510(k)) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).