Search Results

This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve SP has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

AiCE (Advanced Intelligent Clear IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

PIQE is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Neural Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac, abdomen, 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 Neural 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.

The Aquilion Serve SP (TSX-307B) V2.0 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 Serve SP 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.

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 for the Aquilion Serve SP (TSX-307B) V2.0, based on the provided FDA 510(k) clearance letter.

Overview of New Features:
The Aquilion Serve SP (TSX-307B) V2.0 introduces two new Deep Learning Reconstruction (DLR) methods:

• PIQE: Enhances spatial resolution and reduces noise for cardiac, abdomen, pelvis, and lung applications.
• CLEAR Motion: Reduces motion artifacts for lung applications.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and results for each new feature. Instead, it describes evaluations and general statements of meeting acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• CLEAR Motion:

  • Clinical Image Quality Evaluation: Five representative clinical cases.
  • Dynamic and Non-Dynamic Phantom Evaluations: Phantoms were used, so not patient data.
  • Data Provenance: Not explicitly stated for the 5 clinical cases, but likely internal Canon Medical Systems data (retrospective, given it's used for evaluating a release). The document mentions "clinical lung CT datasets acquired on the TSX-307B system with iSeries V2.0 SP0000 software."

• PIQE:

  • IQ Metrics Evaluation: Phantom data and "multiple clinical and phantom-based metrics." No specific number of clinical cases mentioned for the testing set.
  • Data Provenance: Not explicitly stated for the testing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the test sets for either CLEAR Motion or PIQE. The evaluations primarily focus on objective phantom measurements and qualitative visual assessments described generally (e.g., "visual improvement," "improved clarity").

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not report a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluations focus on direct image quality improvements, not human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance studies described for both PIQE and CLEAR Motion are standalone algorithm evaluations. They assess the algorithms' direct impact on image characteristics (e.g., noise, spatial resolution, CT number accuracy, motion artifact reduction) using phantoms and clinical datasets, without involving human readers for diagnostic tasks.

7. The Type of Ground Truth Used

• CLEAR Motion:

  • Dynamic Phantom: The "ground truth" is derived from the known setup of the dynamic phantom simulating pulmonary vessel motion, against which the algorithm's ability to reduce artifacts is measured.
  • Non-Dynamic Phantom: The "ground truth" is the known CT number of the water phantom, against which the algorithm's accuracy is measured.
  • Clinical Data: The "ground truth" is implicit and refers to the reduction of visually perceived motion artifacts and preservation of anatomical detail relative to conventional reconstructions. It appears to be based on expert visual assessment (though details on experts are missing).

• PIQE:

  • Phantom Data: The "ground truth" is derived from known phantom characteristics for metrics like CNR, CT number accuracy, uniformity, MTF, NPS, and LCD.
  • Clinical Data: The "ground truth" for the "IQ Metrics Evaluation" is based on improvements in objective image quality metrics and subjective visual assessments related to noise reduction, spatial resolution, and low contrast detectability, likely based on expert visual assessment (again, without specified expert details).

8. The Sample Size for the Training Set

• CLEAR Motion:

  • Trained using 3,400 partial image pairs derived from 37 clinical lung CT cases.
  • Cases covered a range of doses, field-of-view sizes, and helical pitches.

• PIQE:

  • Cardiac imaging: 18 anonymized clinical cases (13 UHR-CT and 5 NR-CT) generating over 13,000 training pairs.
  • Body imaging: 28 cases spanning thoracic to pelvic regions, producing 1,845 large training pairs.
  • Data augmentation techniques were applied.
  • 5% of samples reserved for validation.

9. How the Ground Truth for the Training Set Was Established

• CLEAR Motion:
  The document states the DCNN was "trained to produce motion-compensated images." This implies that the training data likely consisted of pairs or sets of images where motion-affected images were "corrected" by human experts or other techniques to serve as the desired "ground truth" for motion compensation. However, the exact methodology for generating these "motion-compensated" ground truth images is not detailed.

• PIQE:

  • The retraining process used high-resolution AiCE images from an ultra-high-resolution CT system (Aquilion Precision) as targets (i.e., ground truth).
  • Simulated normal-resolution AIDR3D images were used as inputs.
  • This setup suggests a supervised learning approach where the model learns to transform lower-quality (simulated AIDR3D) inputs into higher-quality (Aquilion Precision AiCE) outputs, effectively learning noise reduction and resolution enhancement by mimicking the ideal high-resolution images as ground truth.

Ask a specific question about this device

Self-Propelled CT Scan Base Kit, CGBA-035A:
The movable gantry base unit allows the Aquilion ONE (TSX-308A) system to be installed in the same procedure room as the INFX-8000C system, enabling coordinated clinical use within a shared workspace. This configuration provides longitudinal positioning along the z-axis for image acquisition.

Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP:
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities. The Calculated Dose Area Product (DAP) feature provides an alternative method for determining dose metrics without the use of a physical area dosimeter. This function estimates the cumulative reference air kerma, reference air kerma rate, and cumulative dose area product based on system parameters, including X-ray exposure settings, beam hardening filter configuration, beam limiting device position, and region of interest (ROI) filter status. The calculation method is calibration-dependent, with accuracy contingent upon periodic calibration against reference measurements.

The Alphenix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-308A. This combination enables patient access and efficient workflow for interventional procedures. Self-Propelled CT Scan Base Kit, CGBA-035A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the fixed catheterization table utilized by the interventional x-ray system, INFX-8000C. The Self-Propelled CT Scan Base Kit, CGBA-035A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.

The Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP, is an interventional x-ray system with a ceiling suspended C-arm as its main configuration. Additional units include a patient table, x-ray high-voltage generator and a digital radiography system. The C-arms can be configured with designated x-ray detectors and supporting hardware (e.g. x-ray tube and diagnostic x-ray beam limiting device). The INFX-8000C system incorporates a Calculated Dose Area Product (DAP) feature, which provides an alternative method for determining dose metrics without the use of a physical area dosimeter. This function estimates the cumulative reference air kerma, reference air kerma rate, and cumulative dose area product based on system parameters, including X-ray exposure settings, beam hardening filter configuration, beam limiting device position, and region of interest (ROI) filter status. The calculation method is calibration-dependent, with accuracy contingent upon periodic calibration against reference measurements.

N/A

Ask a specific question about this device