(111 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 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.
The TSX-301B is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
The provided text lacks specific details regarding acceptance criteria and a detailed study proving the device meets them. The submission primarily focuses on the device's substantial equivalence to a predicate device and its ability to reduce radiation exposure through an iterative reconstruction algorithm.
However, based on the information available, here's an attempt to answer the questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria (e.g., minimum spatial resolution, contrast-to-noise ratio). It broadly mentions "accepted image quality metrics" and "reduction of radiation exposure."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Image Quality (visual assessment) | "utilized phantoms and accepted image quality metrics." "modification allows for the use of an iterative reconstruction algorithm..." |
| Radiation Dose Reduction | "reduce radiation exposure to the patient." "provides the user the ability to perform scans at lower doses." |
| Functionality | Device continues 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." Materials, hardware, method of operation, base software and manufacturing processes remain unchanged. |
| Safety | "designed and manufactured under the Quality System Regulations... in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard... will be met." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document states "The testing conducted on this device utilized phantoms." There is no mention of human subject data, and therefore no information on the sample size of a test set derived from human subjects.
- Data Provenance: Not applicable, as testing was conducted on phantoms.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as testing involved phantoms, not human data requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable, as testing involved phantoms.
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:
Not applicable. This submission focuses on hardware and a reconstruction algorithm, not an AI-assisted diagnostic tool for human readers. There is no mention of a human-in-the-loop study or human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the testing described appears to be a standalone evaluation of the device and its iterative reconstruction algorithm using phantoms. The document states, "The testing conducted on this device utilized phantoms and accepted image quality metrics." The focus is on the technical performance of the device itself and its ability to achieve lower doses while maintaining image quality.
7. The Type of Ground Truth Used:
For the phantom testing, the ground truth would be the known physical properties and compositions of the phantoms themselves, along with established metrics for image quality (e.g., spatial resolution targets, contrast targets).
8. The Sample Size for the Training Set:
Not applicable. The document describes a modification to an existing CT scanner (TSX-301B Aquilion Premium) with the addition of an iterative reconstruction algorithm. This is not a description of a machine learning model that would require a "training set" in the conventional sense for a completely new AI algorithm. The iterative reconstruction algorithm itself might have been developed and "trained" on data internally by the manufacturer, but this information is not provided in the 510(k) summary.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as this information is not provided and the context suggests a traditional iterative reconstruction algorithm rather than a machine learning model with explicitly defined training and ground truth from external datasets.
§ 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.