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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The systems with 160 mm detector coverage have the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cardiac, and Gated CT scan techniques from patients of 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 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 can acquire CT images using different kV levels of the same anatomical region of a patient in 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.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus nonuric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

The Revolution CT family of products, including Revolution CT, Revolution CT ES, Revolution CT with Apex edition, Revolution CT ES with Apex edition Apex, Revolution Apex Elite, Revolution Apex Plus, and Revolution Apex Select, Revolution CT Power, Revolution Apex Pro are multi-slice CT scanners consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

GE has modified the cleared Revolution CT (K19177) within our design controls to include the 0.23 s/rot option. The 0.23s/rot option can be used with axial scan acquisitions and is especially beneficial during certain cardiac scan acquisitions. The scan workflow and user interface remain identical to the of the predicate device, with the exception that the user now has the option to select 0.23 s/rot in addition to other gantry rotation speeds.

The addition of a new maximum gantry rotation speed leads to updates to system performance claims about maximum temporal resolution when combined with the optional Snapshot Freeze 2 (K183161) feature.

The provided text does not contain detailed acceptance criteria for the device or a study explicitly proving the device meets said criteria. The document is a 510(k) premarket notification for a Computed Tomography (CT) system (Revolution CT family) that includes the addition of a 0.23 s/rot option. The focus of the submission is to demonstrate substantial equivalence to a predicate device (Revolution CT, K191777), not to present an independent study with explicit acceptance criteria for a novel device performance claim.

However, based on the information provided, we can infer some aspects related to evaluating the new 0.23 s/rot option:

Inferred Acceptance Criteria and Reported Device Performance (Focusing on the 0.23 s/rot option)

Detailed Breakdown of Study Information (Focusing on the 0.23 s/rot option):

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

   • Test Set Sample Size: Not explicitly stated by number of cases or patients. The non-clinical testing involved "a cardiac phantom" and "mathematical modeling." This implies a phantom-based study for physical performance and computational analysis.
   • Data Provenance: The study was non-clinical and conducted by the manufacturer, GE Medical Systems, LLC. It's an internal validation of the new feature.

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

   • This information is not provided in a way that aligns with "ground truth" for a clinical test set, as no clinical study was performed. The evaluation relied on technical performance metrics validated against engineering standards and a cardiac phantom, rather than expert interpretation of medical images.

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

   • Not applicable as there was no clinical test set requiring expert adjudication. The substantiation was based on physical measurements from a phantom and mathematical modeling.

4. 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:

   • No MRMC comparative effectiveness study was done. This submission is for a hardware/software update to a CT scanner, not an AI-assisted diagnostic tool.

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

   • The evaluation focused on the standalone performance of the CT system with the new gantry rotation speed. The "algorithm" here refers to the system's operational parameters and image reconstruction, rather than a diagnostic AI algorithm. The performance items were verified and substantiated through phantom studies and mathematical analysis.

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

   • For the non-clinical testing, the "ground truth" was likely established by:
     • Physical measurements/known properties of the cardiac phantom: For evaluating temporal resolution and other imaging characteristics.
     • Engineering specifications and mathematical models: To predict and verify performance parameters.

7. The sample size for the training set:

   • Not applicable in the context of this submission. The device is a CT scanner with a hardware and software update, not a machine learning algorithm that requires a specific "training set" of patient data in the typical sense. The development involved general engineering design, development, and verification processes.

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

   • Not applicable as there was no distinct "training set" for a machine learning model. The system's design and engineering would be based on established physics, engineering principles, and prior knowledge from existing CT technology, rather than a labeled training dataset.

Summary of the Study:

The study was a non-clinical performance evaluation conducted by GE Medical Systems, LLC. It involved:

• Engineering testing: To ensure compliance with electrical, mechanical, and safety standards (IEC 60601-1 Ed. 3.1, 21CFR Subchapter J, NEMA XR-25, XR-26, and XR-28).
• Performance evaluation testing: Utilized a cardiac phantom and mathematical modeling to technically substantiate claims related to the 0.23 s/rot option, particularly in conjunction with the Snapshot Freeze 2 feature for temporal resolution.
• Quality System Compliance: The development followed the Quality System Regulations of 21CFR 820 and ISO 13485, including risk analysis, technical reviews, design reviews, code inspections, and various levels of testing (unit, integration, performance, safety, simulated use).

The conclusion was that the device, with the new 0.23 s/rot option, is "as safe and effective, and performs in a substantially equivalent manner to the predicate device Revolution CT (K191777)." No clinical testing was deemed necessary because the modifications were fully testable on an engineering bench.

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