(158 days)
This device is indicated to acquire and display cross sectional volumes of the whole 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, of the whole organ by a trained and qualified physician.
FIRST 1.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for chest (excluding cardiac), abdomen and pelvis applications. This algorithm is not intended for head or extremity applications.
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) 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 Toshiba CT systems. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 1.0, intended to reduce exposure dose while maintaining and/or improving image quality.
The provided text describes the Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) CT system and its iterative reconstruction algorithm, FIRST 1.0. Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal of FIRST 1.0) | Reported Device Performance (Summary) |
|---|---|
| Reduce exposure dose | Up to 82.2% dose reduction compared to FBP for equivalent low contrast detectability. |
| Improve high contrast spatial resolution | Improved spatial resolution over FBP. |
| Maintain and/or improve image quality | Equivalent low contrast detectability to FBP with dose reduction. Visual reduction of streak artifacts and improved image SD values in shoulders compared to AIDR 3D. Diagnostic quality images (visually confirmed by Radiologist). |
| No significant artifacts/missing anatomical structures | Visually confirmed (by Radiologist) that no significant artifacts and missing anatomical structures occur. |
2. Sample Size Used for the Test Set and Data Provenance
- Quantitative Dose Reduction Evaluation: A simulated body phantom (MITA-FDA phantom with a body ellipse surrounding it) was used. This indicates a phantom study, not human data.
- Artifact Reduction: A body phantom was used for truncation and streak artifact assessment. This indicates a phantom study.
- Image Quality Check: Existing clinical data was used. The specific sample size of clinical cases is not provided. The provenance of this clinical data (e.g., country of origin, retrospective/prospective) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For the "Image Quality Check" using existing clinical data, one American Board Certified Radiologist reviewed a representative diagnostic image set for chest, abdomen, and pelvis exams. Their specific years of experience are not provided, only that they are "American Board Certified."
- For the quantitative dose reduction and artifact reduction studies, phantoms were used, so expert ground truth establishment for patient images was not directly applicable.
4. Adjudication Method for the Test Set
- For the image quality check, with only one American Board Certified Radiologist reviewing images, there was no adjudication method (e.g., 2+1, 3+1) described.
- For the phantom studies, the assessment was based on objective measurements (e.g., model observer evaluation, image SD values) and visual comparison to AIDR 3D, and thus, an adjudication method for experts was not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly described. The document mentions a single radiologist's review of diagnostic images and phantom studies. No comparison of human reader performance with and without AI assistance is presented.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance assessment was conducted for FIRST 1.0.
- Quantitative Dose Reduction Evaluation: This was performed using a "model observer evaluation" on a phantom, indicating an algorithm-only assessment of low contrast detectability.
- Image Quality Evaluation (Phantom Studies): Various CT image quality metrics (spatial resolution, CT number accuracy, contrast-to-noise ratio, noise properties, uniformity, slice sensitivity profile, low contrast detectability, standard deviation of noise) were measured using phantoms, which are objective algorithm-only assessments.
- Artifact Reduction (Phantom Studies): Objective measures like image SD values and visual comparisons (implied to be algorithm output comparison) were made.
7. The Type of Ground Truth Used
- Phantom Measurements: For quantitative dose reduction, spatial resolution, CT number accuracy, CNR, noise properties, uniformity, SSP, low contrast detectability, and artifact reduction, the ground truth was derived from objective measurements on phantoms (e.g., MITA-FDA phantom, body phantoms).
- Expert Visual Confirmation: For the "Image quality check" using clinical data, the ground truth for "diagnostic quality" and "no significant artifacts and missing anatomical structures" was established by visual confirmation from a single American Board Certified Radiologist.
8. The Sample Size for the Training Set
- The document does not provide any information regarding the sample size used for training the FIRST 1.0 algorithm.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide any information regarding how the ground truth for the training set was established.
§ 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.