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The Discovery CT590 RT/Optima CT580 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 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 Discovery CT590 RT/Optima CT580 Computed Tomography Systems are indicated 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 system is 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 system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

If the Deviceless 4D option is included on the system, the system can be used to efficiently provide and display CT images of all phases of a breathing cycle for the evaluation of respiration-induced motion of the chest for use with therapy planning and simulation.

The software calculates the breathing period to determine the Cine acquisition duration and the cine time between images which is automatically imported to the 4D cine acquisition. The software then uses information derived from the imaging for the binning process.

Deviceless 4D is a software option used for capturing the respiratory cycle and binning the image such that the target motion may be obtained for treatment planning. Deviceless 4D has the same intended use and clinical output of Advantaae 4D (A4D,K032915) which was included in the cleared Discovery CT590 RT/ Optima CT580 (K093581) CT system. Deviceless 4D is an alternative and efficient solution for 4D imaging and virtual simulation without the need for an external respiratory monitoring device.

Deviceless 4D first uses a "scout-like" scan type called "SmartBreath" to determine the stable breathing cycle period that is then automatically implemented into the scan parameters for the Cine scans.

D4D incorporates a design that uses internal anatomic features of the respiratory cycle obtained during the Cine scans for image binning. These features are temporally registered to the actual breathing cycle.

The Discovery CT590 RT and Optima CT580 series of systems are composed of a gantry, patient table, operator console, computer, and power distribution unit (PDU), and interconnecting cables. The systems include image acquisition hardware, image acquisition, reconstruction software, associated accessories, and connections/interfaces to accessories.

The current systems are an evolutionary modification to the Discovery CT590 RT and Optima CT580 (K093581) by adding software features, quality fixes, IEC Ed. 3 compliance, and modifications in hardware for RoHS compliance and technology obsolesces.

The "16-slice", system generates cross-sectional images of the body by computer reconstruction transmission data taken at different angles and planes, including Axial. Cine, Helical (Volumetric) and gated acquisition modes. It has a maximum total collimation coverage of 20mm in the z direction.

The Discovery CT 590 RT and Optima CT 580 series of systems are designed to be a head and whole body CT systems incorporating the same basic fundamental operating principles and similar indications for use.

The provided submission focuses on establishing substantial equivalence for the GE Discovery CT590 RT/Optima CT580 with Deviceless 4D Option to its predicate devices, rather than presenting a detailed independent study with explicit acceptance criteria for the new feature or a comparative effectiveness study with human readers.

However, based on the information provided, here's a breakdown addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for the Deviceless 4D option. Instead, the "acceptance criteria" are implied through the demonstration of equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "clinical datasets from GE's internal development database" were used. However, the exact sample size (number of patients or scans) for this test set is not specified.
• Data Provenance: The data was sourced from "GE's internal development database," implying it's likely internal to GE and potentially collected from various regions where GE conducts development. The document does not specify the country of origin or whether it was retrospective or prospective. Given it's an "internal development database," it's highly likely to be retrospective data collected during prior development or clinical evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The submission does not mention using experts to establish ground truth for the test set or their qualifications. The comparison was primarily performed against the predicate device's output (Advantage 4D) as the reference.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The comparison was made directly between the D4D feature's output and the predicate A4D's output using statistical analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this submission. The focus was on demonstrating the technical equivalence of the D4D software to the existing A4D software using phantom and internal clinical data. There is no mention of human reader performance or improvements with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance evaluation of the Deviceless 4D (D4D) algorithm was performed.

• "Bench testing of and image review of the D4D feature provided additional data that this feature works both as intended and to provide the requisite data to substantiate performance claims, safety and efficacy, and ultimately substantial equivalence."
• "The testing performed included testing using a commercially available breathing phantom... and clinical datasets from GE's internal development database were used to compare the binning and measurement of D4D to the predicate feature A4D."
  This clearly indicates that the algorithm's output was directly compared against a reference (the predicate A4D and phantom measurements).

7. Type of Ground Truth Used

The ground truth used for the D4D evaluation was effectively the output of the predicate device's Advantage 4D (A4D) feature for binning and measurement from clinical datasets, and measurements from a commercially available breathing phantom for assessing breathing periodicity detection. This can be considered a form of "reference standard comparison" where the established performance of a cleared device or a known physical property (phantom) serves as the truth.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only mentions the use of "GE's internal development data base" for clinical datasets used in testing, but it's unclear if this same database was used for training or if other data was used, and if so, how much.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. Given the nature of a 510(k) submission focused on substantial equivalence to an existing device, a detailed account of training data ground truthing might not be deemed necessary if the underlying technology is largely similar and the primary claim is equivalence rather than novel performance.

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