(99 days)
The "Brilliance iCT" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components, and accessories.
The Brilliance iCT is a Whole Body Computed Tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories.
The submitted text describes a 510(k) summary for the Brilliance iCT, a Computed Tomography (CT) X-Ray System. The summary focuses on demonstrating the substantial equivalence of a modified version of the Brilliance iCT to its predicate device, "Brilliance Volume," by highlighting technical characteristics and performance data.
Here's an analysis of the provided information, structured to address your specific questions. It's important to note that the document is a 510(k) summary for a CT scanner, not necessarily an AI-powered diagnostic device in the modern sense. Therefore, many of your questions related to AI-specific studies (like MRMC, training sets, ground truth for AI, etc.) are not directly applicable or detailed in this type of submission for a CT hardware modification.
Acceptance Criteria and Device Performance
The study primarily focuses on demonstrating that the modified Brilliance iCT continues to meet established performance standards for CT systems, particularly IEC 61223-3-5:2004. The acceptance criteria are implicit in compliance with this standard, which outlines specific acceptance tests for the imaging performance of CT X-ray equipment.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit from IEC 61223-3-5:2004) | Reported Device Performance (Demonstrated by Bench Tests) |
|---|---|
| CT Number Accuracy and Consistency | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: CT Number Measurements" |
| Image Uniformity | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Uniformity Measurements" |
| Image Noise Levels | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Noise Measurements" |
| Tomographic Section Thickness Accuracy | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Tomographic Section Thickness Measurements" |
| CTDI Dose Accuracy | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: CTDI Dose Measurements" |
| Air Dose Accuracy | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Air Dose Measurements" |
| Spatial Resolution | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Spatial Resolution Measurements" |
| Low Contrast Detectability | "Demonstrated that the modified Brilliance iCT system continues to conform to IEC 61223-3-5:2004: Low Contrast Detectability Measurements" |
| Diagnostic Image Quality | "Clinical evaluation demonstrated that images... have been evaluated by a radiologist as being of diagnostic quality." |
Detailed Responses to Specific Questions:
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A table of acceptance criteria and the reported device performance:
- See the table above. The acceptance criteria are based on compliance with IEC 61223-3-5:2004, and the performance is stated as meeting this standard for each listed measurement. A clinical evaluation also confirmed diagnostic image quality.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "bench tests" for the technical performance measurements. These typically involve phantoms and laboratory setups, not human patient data in the sense of a clinical trial.
- For the "Clinical evaluation," the sample size of cases/images is not specified.
- The data provenance (country of origin, retrospective/prospective) is not mentioned for either bench tests or clinical evaluation.
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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):
- For the technical performance measurements (CT Number, Noise, Resolution, etc.), the "ground truth" is established by physical measurement standards and the test methodology dictated by IEC 61223-3-5:2004, not by human experts.
- For the "Clinical evaluation," it states "images... have been evaluated by a radiologist as being of diagnostic quality." The number is one radiologist, and their specific qualifications (e.g., years of experience) are not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Given that only "a radiologist" is mentioned for the clinical evaluation, it implies no multi-reader adjudication method was used. For the technical bench tests, adjudication by human experts is not applicable.
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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 study was done or reported. This submission pertains to a modification of a CT scanner's hardware (detection array and supporting software), not an AI-powered diagnostic tool in the sense of one that assists human readers. The clinical evaluation mentioned is a basic check for diagnostic quality of the reconstructed images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the context of this device. The Brilliance iCT is a CT scanner, which provides images for human interpretation, not an algorithm providing a standalone diagnostic output. The "algorithm only" performance refers to the image reconstruction algorithm's output, which is then clinically evaluated by a radiologist. The technical bench tests assess the fundamental image quality parameters, which are (in a way) "standalone" performance metrics of the hardware and reconstruction.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical performance measurements, the "ground truth" is based on the physical properties of phantoms and measurement standards defined by IEC 61223-3-5:2004.
- For the clinical evaluation, the ground truth for "diagnostic quality" appears to be the subjective assessment of a single radiologist. This is not equivalent to pathology or outcomes data.
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The sample size for the training set:
- Not applicable / Not mentioned. This document describes the modification of a CT scanner hardware and its performance, not an AI algorithm that would typically require a training set in the sense of machine learning. The "supporting software" mentioned would be for image reconstruction and system control, not a learned model.
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How the ground truth for the training set was established:
- Not applicable / Not mentioned for the same reasons as point 8.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.