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The CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of xray transmission data taken at different angles and planes. The CTXXX85 CT scanner systems are indicated for head and whole-body X-ray Computed Tomography applications for both pediatric and adult patients. The images delivered by the system can be used by a trained physician and trained healthcare professionals as an aid in diagnosis, treatment preparation and radiation therapy planning.

The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration). The CTXX85 system is designed for routine radiological imaging procedures as well as advanced techniques such as coronary CT angiography, brain / organ perfusion, cardiac imaging with gated ECG, and CT-guided procedures. The CTXX85 system is designed with LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution and Iterative Bone Correction (IBC) in scan protocols associated with Head patient anatomy. The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box). Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder, QA phantom and mount, CIVCO table overlay and cardiac trigger module (CTM).

The provided text describes a 510(k) premarket notification for a CT scanner (CTXX85 with software version 1.3). The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/ML-based device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/ML performance.

The submission confirms that:

• No clinical studies were required or conducted to support the substantial equivalence claim.
• The device's enhancements are primarily related to software-based algorithms (Metal Artifact Reduction, Extended Field of View), and new accessories/functionalities, rather than a completely new AI/ML diagnostic algorithm requiring extensive clinical validation.
• Performance data was collected through non-clinical test/performance testing (bench testing, phantom tests), adhering to various international and FDA consensus standards related to CT image quality, electrical safety, EMC, and software life-cycle processes.

Without a clinical study, details like sample size for a test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics are not available in this document.

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