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The GE Optima CT520 Computed Tomography X-ray system is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, 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 Optima CT520 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.

The Optima CT520 CT Scanner System is composed of a gantry, patient table, operator console, and line voltage adaptor. It also includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories.

The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry can rotate at up to 0.8 seconds per rotation. and can acquire up to 16 slices/rows of data per rotation with a maximum total collimation coverage of 20mm in the z direction. The system can be operated in Axial, Cine, Helical, Cardiac and Gated acquisition modes.

To improve the siting footprint, the power distribution unit (PDU) has been integrated into the gantry base; except for standalone line voltage adaptor, if needed. The PDU components' function and performance remain the same. This change has been fully tested and certified by a NRTL to continue to meet all applicable IEC/UL safety standards.

The Optima CT520 represents evolutionary modifications to the predicate device (BrightSpeed Elite Select CT System (K082816)). The modifications include hardware upgrades due to technology obsolesces (e.g. console), ROHS compliance, system siting footprint optimization, and IEC Edition 3 compliance, as well as software changes to improve workflow and usability. incorporate Dose Check and quality fixes, assist in product marketing position by feature availability, and feature technology flow-down from cleared premium tier products (e.g. ASiR), The Optima CT520 is a general purpose, mid-tier 16-slice CT scanner that incorporates GE's innovative technology and feature functionality.

The Optima CT520 uses virtually the same materials and identical operating principle as our existing marketed product, except in the case of using the compensatory ROHS compliance material. The image chain components (tube, collimator, detector. DAS) are virtually identical to the BrightSpeed Elite Select.

The changes do not affect the intended use, the indications for use, patient population nor fundamental operating principles of the currently commercially available predicate system and are the identical or similar to other GE CT systems and features previously cleared.

The GE Optima CT520 is a Computed Tomography (CT) X-ray system. The modifications to the predicate device (BrightSpeed Elite Select CT System (K082816)) primarily involve hardware upgrades due to technology obsolescence (e.g., console), ROHS compliance, system siting footprint optimization, IEC Edition 3 compliance, and software changes to improve workflow and usability, incorporate Dose Check, and other enhancements. The device uses virtually the same materials and identical operating principles as its predicate.

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

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

• Test Set: No specific numerical sample size is provided for a dedicated "test set" in the context of a clinical performance study. The primary method of demonstrating substantial equivalence involved engineering testing and an assessment of "sample clinical images."
• Data Provenance: The document does not specify the country of origin for the "sample clinical images" or whether they were retrospective or prospective. It only states that "sample clinical images representing a various acquisition modes and body regions were provided for reference."

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

• Number of Experts: Two independent radiologists.
• Qualifications of Experts: Not specified beyond being "independent radiologists." No details like years of experience or subspecialty are provided.

4. Adjudication method for the test set:

• Adjudication method: A Likert scale assessment was provided by the two independent radiologists. The document does not specify an adjudication method like 2+1 or 3+1; rather, it suggests an individual assessment by each radiologist.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The submission explicitly states, "Clinical data was not needed to establish safety and effectiveness, all changes were able to be fully verified and validated on the bench, and the testing did not reveal any new questions of safety or effectiveness." The "sample clinical images" were provided for reference and assessed for diagnostic quality, not as part of a formal MRMC study to compare reader performance with and without AI assistance.

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

• Standalone Performance: Not applicable. The device is a CT scanner, not an AI algorithm intended for standalone diagnostic interpretation without human-in-the-loop performance. The "AI" mentioned in the description refers to "feature technology flow-down from cleared premium tier products (e.g. ASiR)" which likely refers to advanced image reconstruction techniques, not a standalone diagnostic AI algorithm.

7. The type of ground truth used:

• Type of Ground Truth: For the "sample clinical images," the ground truth was based on a Likert scale assessment of diagnostic quality provided by two independent radiologists. This can be categorized as expert consensus/opinion regarding image quality, rather than definitive pathology, clinical outcomes, or a pre-established "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: The document does not mention a specific "training set" sample size. The modifications are described as "evolutionary modifications" and "hardware and software platform changes" building upon a predicate device. The development process emphasizes verification and validation against established standards and internal procedures rather than a machine learning training paradigm with a distinct training set.

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

• Training Set Ground Truth: Not applicable, as no distinct "training set" in the context of machine learning with established ground truth is described. The device's development focused on adherence to existing standards, internal quality control procedures, and demonstrating that the modifications did not alter the fundamental safety and effectiveness of the existing predicate device.

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