(24 days)
This device is indicated to acquire and display cross-sectional volumes of the whole the 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, of the whole organ by a trained and qualified physician.
Aquilion ONE (TSX-306A/3) V10.0 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, c 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 the study information based on the provided text, focusing on what is explicitly stated:
Acceptance Criteria and Reported Device Performance
The provided document describes modifications to an existing Computed Tomography (CT) system (Aquilion ONE) and seeks clearance based on substantial equivalence to a predicate device. The core "acceptance criteria" here relate to demonstrating that the modified device performs similarly to or better than the predicate device, particularly concerning image quality, and that the modifications do not introduce new safety concerns.
The study presented focuses not on the clinical performance of an AI algorithm, but on demonstrating the image quality equivalence of the modified CT system (Aquilion ONE (TSX-306A/3) V10.0) compared to its predicate (Aquilion ONE (TSX-305A/6) V8.9 with AiCE).
| Acceptance Criteria Category | Specific Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|---|
| Image Quality | Standard deviation of noise (CT number accuracy) | Demonstrated substantial equivalence to predicate device. |
| Image Standard Deviation (SD) | Demonstrated substantial equivalence to predicate device. | |
| Spatial Resolution (High Contrast Detectability) | Demonstrated substantial equivalence to predicate device. | |
| Density Resolution (Low Contrast Detectability) | Demonstrated substantial equivalence to predicate device. | |
| Safety | Conformance to Quality System Regulations (21 CFR § 820 and ISO 13485 Standards) | Compliant |
| Conformance to applicable IEC standards (e.g., IEC60601-1-1, IEC60601-2-28) | Compliant | |
| Conformance to radiation safety performance standards (21 CFR §1010 and §1020) | Compliant | |
| Software | Adherence to FDA guidance for software in medical devices (Moderate Level of Concern) | Software documentation included and validated. |
| Cybersecurity | Adherence to FDA guidance for cybersecurity in medical devices | Cybersecurity documentation included. |
Study Details
It's important to note that this submission is for a CT system hardware and software update, not a separate AI-driven diagnostic device or AI assistance tool for human readers. Therefore, many of the typical questions for AI performance studies (like human reader improvement with AI, ground truth for AI training, etc.) are not directly applicable to this specific submission. The "study" here is a technical verification rather than a clinical trial.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the sense of patient data. The testing was phantom-based. The document does not specify the number of phantoms used, but describes the type of tests performed (e.g., assessing different image quality parameters).
- Data Provenance: Not applicable as it was phantom-based testing, not clinical data from patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for phantom-based image quality metrics is inherently defined by the physical characteristics of the phantom and the measurement techniques, not by expert interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was phantom-based objective measurement, not subjective expert adjudication of clinical cases.
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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, an MRMC comparative effectiveness study was not done. This submission is for a CT system update, not an AI assistance device that impacts human reader performance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a CT scanner, not a standalone AI algorithm. While the predicate device included "AiCE" (Canon's Advanced Intelligent Clear-IQ Engine, an AI-based reconstruction technology), the primary focus of this submission's testing is on the general image quality equivalence of the updated system with its modified hardware and software, rather than a specific performance study of AiCE itself or any new AI feature. The subject device removes AiCE as an option from this specific version, indicating the focus is elsewhere.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective physical measurements from phantom-based tests. The "ground truth" for image quality metrics like noise, spatial resolution, and density resolution is established through controlled measurements of known phantom properties, not clinical outcomes or expert consensus.
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The sample size for the training set:
- Not applicable. This document describes the verification of a modified CT system, not the training of a new AI model.
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How the ground truth for the training set was established:
- Not applicable. (See #7).
§ 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.