(28 days)
The 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, including Axial, Cine, Helical (Volumetric), 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 system is indicated for head, whole body, cardiac 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 Revolution Maxima CT system is composed of a gantry, patient table, operator console, host computer, and power distribution unit (PDU), and interconnecting cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories, interconnections. The Revolution Maxima system is an evolutionary configuration of the predicate Optima CT660 CT system (K131576). All of the hardware functionality is identical to the predicate, however, some hardware changes have been made that did not change the system's performance specifications such as the new liquid metal bearing tube for improved tube life and reliability, the upgraded DAS and detector to improve the manufacturability and lower electronic nosie for better low signal performace and thermal management.
Identical to the predicate, Revolution Maxima generates 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), Cardiac, and Gated acquisitions modes. Revolution Maxima's Intended Use and Indications for Use remain identical to those of the predicate device.
The Revolution Maxima CT system is a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. It's materials and construction are identical to our existing marketed products. Revolution Maxima remains compliant with IEC 60601-1 Ed. 3.1 and associated collateral and particular standards, NEMA XR 25, XR 28, and 21 CFR Subchapter J performance standards. The accompanying documents also contain the information in support of IEC61223-3-5 Ed. 1.0 for acceptance testing.
The performance and image quality specifications are identical/equivalent to the predicate. The gantry has a 70 cm bore with a maximum FOV of 50 cm. Available rotation speeds range from 0.35 to 2.0 seconds. Same as the predicate, the Revolution Maxima has three types of reconstruction methods available: FBP, ASiR, and ASiR-V (K133640). The performance of ASiR-V on Revolution Maxima is identical to that on the predicate Optima CT660.
Revolution Maxima includes most of the available features on the current production predicate device Optima CT660. The new changes incorporated into Revolution Maxima are primarily addition of a few features found on other GE current production CT systems, e.g. updated newer ITE host computer, Digital Tilt as an alternative to the tilted gantry, improved metal artifacts reduction called Smart MAR and 1024x1024 Recon. Digital Tilt is a software reformatting of the reconstructed images so that they appear like those reconstructed from a tilted gantry. The smaller pixel sizes of 1024 Recon improves the spatial resolution which is useful in clinical applications that would benefit from increased spatial resolution, especially those applications where a large display field of view is desired to simultaneously image corresponding left/right anatomy for comparison (e.g. highresolution lungs, internal auditory canals).
There are other unique changes for Revolution Maxima which includes new gantry covers with more aesthetic and modern industry design, new gantry display panel on two tablets with high resolution touchscreens, one on each side of the gantry for improved access and usability. These gantry display tablets replace the single display screen located at the top center of the gantry in the predicate device and host the web based user interface for a new and improved workflow called "Express mode" which seamlessly displays the related protocols associated with order information in the RIS
This 510(k) summary for the Revolution Maxima CT system by GE Hangwei Medical Systems Co.,Ltd. describes its substantial equivalence to a predicate device, the Optima CT660. Therefore, the information provided is primarily focused on demonstrating that the new device is as safe and effective as the predicate, rather than establishing de novo acceptance criteria with standalone performance studies against a clinical ground truth.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
There isn't a table of specific acceptance criteria in the traditional sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the Revolution Maxima. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, Optima CT660. The reported device performance is that it performs equivalently to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety and Effectiveness comparble to predicate Optima CT660 | - The Revolution Maxima is as safe and effective as the predicate device Optima CT660 (K131576). |
- Non-clinical bench test results demonstrated the subject device performs equivalently to the predicate device.
- Image quality and dose performance confirmed using standard IQ and QA phantoms.
- Performance testing in accordance with IEC 61223-3-5 ed 2 (FDIS). |
| Compliance with relevant standards and regulations | - In compliance with AAMI/ANSI ES 60601-1 and IEC60601-1 Ed. 3.1 and associated collateral and particular standards. - Compliance to applicable CDRH 21 CFR subchapter J requirements.
- Compliance to NEMA standards XR 25, XR 26, and XR 28.
- Designed and manufactured under the Quality System Regulations of 21 CFR 820 and ISO 13485. |
| Image quality specifications | Identical/equivalent to the predicate (Optima CT660), including ASiR and ASiR-V performance. |
| Functional equivalence | - Operates on the same fundamental principles. - Has the same intended use and indications for use.
- Hardware functionality is identical in some aspects, with new components not changing performance specifications (e.g., tube, DAS, detector for manufacturability and lower electronic noise).
- New features (1024x1024 Recon, Smart MAR, Digital Tilt) are additions, not changes to core functionality. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "The Revolution Maxima can be fully tested on the engineering bench thus no additional clinical testing was required." This indicates that no human patient imaging test set was used for a clinical study to establish standalone diagnostic performance. Instead, testing relied on non-clinical bench tests, image quality and QA phantoms.
Therefore:
- Sample size for test set: Not applicable (no human patient test set).
- Data provenance: Not applicable (no human patient data). The data provenance refers to phantom and bench test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical test set was used, there were no experts needed to establish ground truth for a clinical diagnostic performance evaluation. The "ground truth" for the non-clinical tests would be the known properties of the phantoms and the expected physical performance metrics, assessed by engineers and physicists rather than medical experts for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
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
No such MRMC study was performed or is mentioned. The device is a CT scanner, not an AI-assisted diagnostic tool that integrates with human readers in that manner. The "AI" mentioned (ASiR, ASiR-V) are iterative reconstruction algorithms incorporated into the image processing of the CT scanner itself to improve image quality and reduce dose, not a separate AI system intended for radiologists' interpretative assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the CT system itself in generating images. The non-clinical testing served this purpose:
- Standalone Performance: Yes, standalone system performance was evaluated through non-clinical bench tests, image quality (IQ), and dose performance using standard IQ and QA phantoms. This includes specific tests like Metal Artifact Reduction (MAR) testing and image quality testing on 1024x1024 Recon, and performance testing in accordance with IEC 61223-3-5 ed 2 (FDIS). The results demonstrated equivalence to the predicate device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was based on:
- Known phantom properties: Phantoms designed with specific, measurable physical characteristics (e.g., density, spatial resolution patterns).
- Physical laws and engineering specifications: The expected performance based on the design and validated against established physical principles and engineering parameters.
- Compliance with industry standards: Meeting the specified requirements of standards like IEC 61223-3-5, NEMA XR 25, 26, 28, etc.
8. The Sample Size for the Training Set
Not applicable. This is a 510(k) for a CT scanner, not a machine learning algorithm that requires a training set of images with ground truth labels. While the iterative reconstruction algorithms (ASiR, ASiR-V) might have involved data for their development, that information is not part of this 510(k) summary focused on the substantial equivalence of the overall CT system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set in this context.
§ 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.