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The Discovery CT590 RT and Optima CT580 series of Computed Tomography systems are 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), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages. These images may be obtained either with or without contrast. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.

These devices 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 Discovery CT590 RT and Optima CT580 series of Computed Tomography systems are intended for head, whole body, 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 systems are capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40).

The systems can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

The Discovery CT590 RT and Optima CT580 series of systems are composed of a gantry, patient table, operator console, computer, power distribution unit (PDU) and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The Discovery CT590 RT and Optima CT580 series of systems is an evolutionary modification to the LightSpeed RT® / Xtra V2 CT systems (K082104). It is developed from the hardware platform of the LightSpeed RT16 / Xtra V2 systems by adding new application features, modifications in design that involve changes in hardware, software, firmware, and recon.

The Discovery CT590 RT and Optima CT580 series of systems are designed to be a head and whole body CT system 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) submission for the GE Discovery CT590 RT and Optima CT580 series of CT systems does not contain specific acceptance criteria, performance data, or a detailed study demonstrating how the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GE LightSpeed RT16 / Xtra CT System, K082104) by outlining the device description, intended use, and emphasizing that it is an "evolutionary modification" that uses similar materials, operating principles, and has the same indications for use as the predicate. The document states that the new system "does not result in any new potential safety risks and performs as well as or better than devices currently on the market."

The "CONCLUSION" section highlights adherence to regulatory standards (21CFR 1020.30, 1020.33, UL 60601-1, IEC 60601-1) rather than specific performance metrics against pre-defined acceptance criteria.

Therefore, the requested information cannot be fully provided from the given document.

However, based on the information provided, here's a summary of what can be inferred or directly stated:

1. A table of acceptance criteria and the reported device performance:

This information is not present in the provided document. The 510(k) focuses on substantial equivalence based on design and intended use rather than presenting a performance study with specific acceptance criteria and results. It implies that performance is "as well as or better than" the predicate, but no quantitative criteria or data are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not present in the provided document. No specific test set or study validating performance is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not present in the provided document. No test set requiring ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not present in the provided document.

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:

This information is not present in the provided document. The device is a CT imaging system, not an AI-assisted diagnostic tool for human readers in the context of comparative effectiveness.

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

This information is not present in the provided document. The device is a CT scanner, and its primary output is images for human interpretation, not a standalone algorithmic diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not present in the provided document, as no specific performance study with ground truth is detailed.

8. The sample size for the training set:

This information is not present in the provided document. There is no mention of a "training set" in the context of algorithmic development for this medical device, as it is a CT scanner rather than an AI/ML algorithm requiring such training.

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

This information is not present in the provided document, for the same reasons as point 8.

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