(30 days)
The Analogic CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 CT Scanner systems are indicated for pediatric and adult patients.
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 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.
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 and QA phantom and mount.
The provided text describes specific performance data for the Analogic CTXX85 CT Scanner, particularly focusing on the CT1685 model and its iterative reconstruction algorithm (LISA). However, the document does not present a formal table of acceptance criteria with corresponding reported device performance, nor does it detail a clinical study with specific metrics like sensitivity, specificity, or reader performance improvement (MRMC).
Based on the information provided, here's a breakdown of the requested elements:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of acceptance criteria with precise numerical targets. Instead, it indicates that the device's performance was evaluated against a set of standards and for image quality. The general acceptance criterion seems to be that the device "performs as intended" and its image quality is "diagnostic."
| Acceptance Criteria Category | Specific Criteria (Implicit/General) | Reported Device Performance Statement |
|---|---|---|
| Bench Testing Compliance | Fulfills requirements of the following FDA consensus standards and performance requirements for 21CFR §1020.30, §1020.33, and specific IEC/NEMA standards (IEC61223-2-6, IEC61223-3-5, IEC 60601-2-44, NEMA PS 3.1 - 3.20, IEC 60601-1-3, NEMA XR 25, NEMA XR 28, IEEE Std. 3333.2.1, IEC 62366, IEC 60825). | "Bench testing was performed and the new scanner model CT1685 fulfills the requirements..." and "The result of all conducted testing was found acceptable to support the claim of substantial equivalence." |
| Image Quality | Assessment of modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body using standard phantom models. Performance of the iterative reconstruction algorithm (LISA) in reducing image noise while maintaining (or improving) spatial resolution. Images reconstructed via FBP and LISA with different strengths must be of diagnostic quality. | "Image Quality performance testing for the CT1685 was conducted on standard phantom models to assess [list of metrics]... The results of these tests demonstrate that the proposed device performs as intended." and "Sample clinical images... were evaluated by a board-certified radiologist to confirm that the images were of diagnostic quality." |
| Biocompatibility | Patient contacting accessories (patient table CT slicker cushion, head holder, wedge knee pad, table top and patient restraints) comply with AAMI/ANSI/ISO 10993-1 for Surface Contact: Skin, Duration: Limited |
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.