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The GE Revolution ACT 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, for patients of all ages, including Axial, Cine, Helical.

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 Revolution ACT CT Scanner System is indicated for head, whole body 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 multi-slice GE Revolution ACT CT scanner is currently commercially available and in clinical use in various other countries including the EU, Japan, China, and India.

It is a general purpose, 16-slice (detector row) CT scanning system with a z-coverage of 20 mm and a maximum gantry rotation speed of 0.98 seconds. Revolution ACT is designed to help enable greater patient access to CT imaging in facilities that otherwise might not be able to obtain multi-slice CT technology with both current standard and advanced CT features and function.

Revolution ACT uses the same technology, operating principles, features, and functions as the GE Optima CT520 predicate device (K123596) and other cleared GE CT scanners. The system consists of the gantry, patient table, operator console, power distribution unit (PDU), associated accessories, and software options. The Revolution ACT is also available in an 8-detector row (10 mm z-coveragre configuration (Revolution ACTs) using the identical (but depopulated) detector/DAS. The changes from the predicate device do not affect the intended use or patient population.

Becaues the Revolution ACT does not support cardiac or other gated acquisitions, and has a slower rotation time thatn the predicate device, its indications for use were modified by removing cardiac and gated acquisitions and cardiac applications.

The provided text describes the Revolution ACT Computed Tomography X-ray system and its substantial equivalence to the predicate device, Optima CT520. However, the text does NOT contain specific acceptance criteria with numerical values or a direct comparative study that reports device performance against such criteria for AI-related functions.

The document mainly focuses on establishing substantial equivalence to a predicate device for a CT scanner system, emphasizing hardware and imaging performance rather than an AI/ML component with specific performance metrics.

Based on the provided text, here’s a breakdown of the requested information, highlighting where the information is absent:

Acceptance Criteria and Study for Revolution ACT CT Scanner System (as per provided document)

The document primarily establishes substantial equivalence for a CT scanner system, Revolution ACT, to a predicate device, Optima CT520 (K123596). It focuses on the device's ability to produce cross-sectional images for diagnostic purposes. The "acceptance criteria" discussed are largely tied to compliance with standards and demonstration of equivalent performance to the predicate device in terms of image quality and safety.

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

The document explicitly states that the Revolution ACT "maintains virtually the same image quality specifications and dose performance as its predicate" and that "verification testing along with additional engineering testing demonstrated Revolution ACT's equivalent performance to currently marketed the predicate and other cleared GE CT devices and is therefore as safe and effective."

However, a quantitative table with specific acceptance criteria (e.g., minimum spatial resolution, maximum noise level, sensitivity, specificity, or accuracy metrics) and corresponding reported performance values for the Revolution ACT is not provided in the given text. This section of the document describes general compliance and equivalence.

The text mentions a comparison of:

• CT number accuracy
• CT number uniformity
• Image noise (standard deviation)
• Modulation Transfer Function (MTF)
• Noise Power Spectrum
• Slice thickness

It states these comparisons were "provided" but does not present the actual values or the acceptance criteria for these metrics.

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

• Test Set Sample Size: Not explicitly stated for specific quantitative performance tests. The document refers to "engineering bench testing" and "images from both a uniform phantom and one with embedded LCD objects."
• Data Provenance: Phantoms were used for engineering bench testing. For clinical verification, "sample clinical images" were reviewed. The origin of these clinical images (e.g., country) is not specified.
• Retrospective or Prospective: Not specified for the clinical images used for review. Phantom studies are inherently controlled.

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

• Number of Experts: "A board certified radiologist." (Singular)
• Qualifications of Experts: "Board certified radiologist."

4. Adjudication method for the test set:

• Adjudication Method: "Sample clinical images reviewed by a board certified radiologist." This implies a single expert review, so no multi-reader adjudication method (e.g., 2+1, 3+1) 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:

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance is not described in the provided text. The device is a CT scanner, and while it has "signal analysis and display equipment" and "data and image processing," the document does not focus on an AI-assisted diagnostic function. The primary focus is on the scanner's core imaging performance and safety. The "SmartPlan" feature mentioned is for workflow enhancement (initial scan setup parameters) and not for diagnostic assistance that would typically be evaluated in an MRMC study for improved reader performance.

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

• Standalone Performance Study: The document does not describe a standalone performance study for an AI algorithm. The device itself (the CT scanner) undergoes performance testing against engineering specifications. The "ASiR" (Adaptive Statistical Iterative Reconstruction) algorithm is mentioned as being ported to new hardware, and its performance is verified through clinical image review by a radiologist, but this is not presented as a standalone AI algorithm evaluation.

7. The type of ground truth used:

• For engineering bench testing: Physical phantoms with known properties (uniform phantom, phantom with embedded LCD objects).
• For clinical image review: Implied clinical diagnosis/reference for the "sample clinical images reviewed by a board certified radiologist." However, the explicit nature of this ground truth (e.g., pathology, outcomes data) is not detailed. It is likely derived from standard clinical practice and radiologist interpretation.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable/not provided. The document describes a CT scanner and its underlying technologies. While reconstruction algorithms like ASiR might involve models, the document does not detail their training or associated datasets. The focus is on the hardware platform and its imaging capabilities.

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

• Ground Truth for Training Set: Not applicable/not provided, as no training set for an AI/ML diagnostic algorithm is described.

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