(132 days)
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, extremities, head, and inner ear applications.
The spectral imaging system allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The Xray dose will be the sum of the dose at each respective tube voltage and current in a rotation. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies. When used by a qualified physician, a potential application is to determine the course of treatment.
PIQE* is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac, abdomen and pelvis, and lung applications, in comparison to FBP and hybrid iterative reconstruction.
CLEAR Motion is a Deep Learning Reconstruction (DLR) method designed to reduce motion artifacts. A Deep Convolutional Network (DCNN) is used to estimate the patient's motion. This information is used in the reconstruction process to obtain lung images with less motion artifacts.
Aquilion ONE (TSX-308A/3) V1.5 is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, it implicitly defines performance through comparisons to a predicate device and statements about image quality.
| Feature / Study Focus | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| PIQE Lung Image Quality (Phantom Study) | Equivalent or improved performance compared to predicate (TSX-306A Aquilion Prism) based on CNR, CT Number Accuracy, Uniformity, SSP, MTF, SD of NPS, LCD. | Concluded that the subject device demonstrated equivalent or improved performance, compared to the predicate device, as demonstrated by the results of the above testing. (Testing included Contrast-to-Noise Ratios, CT Number Accuracy, Uniformity, Slice Sensitivity Profile, Modulation Transfer Function, Standard Deviation of Noise Power Spectra, and Low Contrast Detectability.) |
| PIQE Body Image Quality (Phantom Study) | Equivalent or improved performance compared to predicate (TSX-306A Aquilion Prism) based on CNR, CT Number Accuracy, Uniformity, SSP, MTF, SD of NPS, LCD. | Concluded that the subject device demonstrated equivalent or improved performance, compared to the predicate device, as demonstrated by the results of the above testing. (Testing included Contrast-to-Noise Ratios, CT Number Accuracy, Uniformity, Slice Sensitivity Profile, Modulation Transfer Function, Standard Deviation of Noise Power Spectra, and Low Contrast Detectability.) |
| Spectral Cardiac Image Quality (Phantom Study) | Equivalent or improved performance compared to predicate (TSX-306A Aquilion Prism) based on CNR, CT Number Accuracy, Uniformity, SSP, MTF, SD of NPS, LCD. | Concluded that the subject device demonstrated equivalent or improved performance, compared to the predicate device, as demonstrated by the results of the above testing. (Testing included Contrast-to-Noise Ratios, CT Number Accuracy, Uniformity, Slice Sensitivity Profile, Modulation Transfer Function, Standard Deviation of Noise Power Spectra, and Low Contrast Detectability.) |
| CLEAR Motion Performance (Phantom Study) | Performed as intended, significantly reducing motion artifacts and maintaining CT Numbers compared to standard reconstructed images without CLEAR Motion. | Conclusions from these studies demonstrated that CLEAR Motion performed as intended, in that motion artifacts were significantly reduced and CT Numbers were maintained, compared to standard reconstructed images in which CLEAR Motion was not applied. (Evaluated using a water phantom and a thoracic dynamic phantom at 12 BPM, reconstructed with AIDR3D, AiCE and/or FBP with and without CLEAR Motion applied.) |
| Clinical Image Quality with Subject Device | Images of diagnostic quality. | ...it was confirmed that the reconstructed images using the subject device were of diagnostic quality. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions the use of "phantoms" for image quality evaluations and "clinical images" for performance testing.
- Phantom Studies:
- Sample Size: Not explicitly stated, but multiple phantoms were used (e.g., water phantom, thoracic dynamic phantom). The exact number of scans or reconstructed images from these phantoms is not provided.
- Data Provenance: Not explicitly stated, but phantom studies typically involve controlled, non-clinical data generation.
- Clinical Image Evaluations:
- Sample Size: Not explicitly stated; "Representative body, cardiac, chest, head, and extremity diagnostic images" were used. The exact number of cases is not provided.
- Data Provenance: Implied to be retrospective clinical data, as they are "obtained using the subject device" and "reviewed by American Board-Certified Radiologists." No country of origin is specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated for each specific evaluation. For clinical image evaluation, it states "American Board-Certified Radiologists" (plural), indicating more than one.
- Qualifications of Experts: "American Board-Certified Radiologists." No specific years of experience are mentioned.
4. Adjudication Method for the Test Set:
- Clinical Images: For the clinical image quality evaluation, it states "reviewed by American Board-Certified Radiologists." It doesn't specify an adjudication method (e.g., 2+1, 3+1, none). It implies a consensus or individual assessment to confirm diagnostic quality.
- Phantom Studies: Phantoms have inherent, objective ground truth based on their design and known properties, so expert adjudication isn't typically applicable in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The document focuses on showing substantial equivalence through phantom studies and a general statement about diagnostic quality of clinical images, rather than a comparative study of human readers with and without AI assistance to quantify improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, standalone performance was evaluated. The "Image Quality Evaluations" and "CLEAR Motion Evaluations" using phantoms are examples of standalone performance testing. These tests assess the device's algorithms (PIQE, CLEAR Motion) directly against objective metrics or by comparing reconstructed images for specific features (e.g., noise reduction, motion artifact reduction) without human intervention in the diagnostic process.
7. Type of Ground Truth Used:
- For Phantom Studies (PIQE, CLEAR Motion): Objective ground truth derived from the known physical properties and design of the phantoms (e.g., known image metrics, controlled motion patterns).
- For Clinical Image Quality: Expert consensus/review by "American Board-Certified Radiologists" to confirm "diagnostic quality."
8. Sample Size for the Training Set:
- Not provided. The document describes the device, its features (some of which use Deep Learning Reconstruction), and details of performance testing. It does not include information about the size or nature of the training data used for the AI algorithms (AiCE, PIQE, CLEAR Motion).
9. How the Ground Truth for the Training Set was Established:
- Not provided. As the training set details are absent, the method for establishing its ground truth is also not mentioned.
§ 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.