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The GE LightSpeed CT750 HD 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, Spectral, and Gated acquisitions for all ages. 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 CT750 HD CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

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

If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

The GE LightSpeed CT750 HD CT Scanner System (aka LightSpeed 8.0) 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. The GE LightSpeed CT750 HD Scanner System is an evolutionary modification to LightSpeed 7.1 (K061817). It is developed from the hardware platform of LightSpeed 7.1 32/64 slice system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.

The GE LightSpeed CT750 HD 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.

This 510(k) premarket notification is for the GE LightSpeed CT750 HD CT Scanner, which is a Computed Tomography X-ray System. The submission claims substantial equivalence to the GE LightSpeed 7.1 CT Scanner System (K061817).

1. Table of acceptance criteria and the reported device performance:

The document focuses on substantiating equivalence rather than defining and meeting specific analytical performance acceptance criteria for an AI/CAD system. The acceptance criteria for the GE LightSpeed CT750 HD are implicitly based on demonstrating that it performs as well as or better than the predicate device (GE LightSpeed 7.1) and adheres to relevant safety and regulatory standards.

2. Sample size used for the test set and the data provenance:

The document does not describe a "test set" in the context of evaluating an AI or CAD algorithm. Instead, it describes modifications to a CT scanner system. Therefore, there is no specific sample size of images or patients for a test set mentioned, nor is there information on data provenance (country of origin, retrospective/prospective). The study focuses on system-level verification and validation against technical specifications and regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no test set requiring expert-established ground truth for an AI/CAD algorithm is described. The evaluation is for a CT scanner system's performance and safety.

4. Adjudication method for the test set:

Not applicable, as no test set requiring adjudication for an AI/CAD algorithm is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This submission is for a medical imaging device (CT scanner), not an AI or CAD software intended to assist human readers. Therefore, an MRMC study related to AI assistance is not described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This submission is for a CT scanner, not a standalone AI algorithm.

7. The type of ground truth used:

Not applicable in the context of an AI/CAD algorithm. For the CT scanner system, the "ground truth" implicitly refers to established engineering specifications, performance metrics (e.g., image quality parameters, dose), and compliance with international safety and performance standards. The device's performance is verified and validated against these objective measures.

8. The sample size for the training set:

Not applicable. This submission is for a CT scanner hardware and integrated software system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a machine learning model described in this submission.

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