Search Results

The GE LightSpeed 7.2 Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE LightSpeed 7.2 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The GE LightSpeed 7.2 CT Scanner System is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. It is an evolutionary modification to the LightSpeed 7.1 (K061817). It is developed from the hardware platform of the 64 slice LightSpeed 7.1 system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.

The GE LightSpeed 7.2 CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

The provided text is a 510(k) summary for the GE LightSpeed 7.2 CT Scanner System. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for AI/software-based performance evaluation.

CT scanners, like the GE LightSpeed 7.2, are generally evaluated for performance through a series of technical specifications andphantom studies to ensure image quality, dose, and other physical parameters meet established standards. These standards are typically defined by regulatory bodies (like the FDA, IEC, UL) and industry best practices. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy or performance metrics for each iteration, unless there are significant changes that could impact safety or effectiveness.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This detailed performance data against specific acceptance criteria for a new AI/software feature is not present. The document focuses on regulatory compliance and substantial equivalence to existing CT scanners.
• Sample sizes used for the test set and the data provenance: No such data is provided as there isn't a "test set" in the context of an AI performance evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multicase (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding device evaluation:

The document states that the GE LightSpeed 7.2 CT Scanner System undergoes:

• System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements.
• Adherence and certification to industry and international standards (e.g., UL 60601-1, IEC 60601-1, and associated collateral and particular standards, 21CFR Subchapter J, 21CFR1020.30 and 1020.33 for X-ray requirements).
• Risk management (hazard analysis) to identify and control potential electrical, mechanical, and radiation hazards.
• Compliance with Quality System Regulations of 21CFR820.

The conclusion is that the device is an "evolutionary modification" and "does not result in any new potential safety risks and performs as well as or better than devices currently on the market," and is considered substantially equivalent to predicate devices. This indicates that its performance is presumed to meet the same established safety and effectiveness levels as the predicate devices, which would have undergone their own technical performance evaluations at the time of their clearance.

Ask a specific question about this device