(63 days)
Optional movable gantry base unit for use with an Aquilion PRIME system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).
Note: When installed with the movable gantry base unit, Aquilion PRIME can be used with the INFX-8000C system in the same room.
The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion PRIME. This combination enables patient access and efficient workflow for interventional procedures. CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT is an optional kit intended to be used in conjunction with an Aquilion PRIME / INFX-8000C based IVR-CT system. The subject device is attached to the CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is selected, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, Toshiba INFX-8000C. The intended uses and technological characteristics of the Aquilion PRIME CT System and INFX-8000C Interventional X-Ray System with which this device is used, remain the same.
The provided document is a 510(k) premarket notification for a medical device called the "CGBA-032A, Aquilion™ PRIME Self-Propelled Scan Base Kit for IVR-CT." This notification is for a modification of an existing device and primarily addresses the physical and functional aspects of the new base unit for a CT system, rather than evaluating an AI-powered diagnostic or predictive algorithm.
Therefore, many of the requested criteria, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, ground truth establishment by experts, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable or not detailed in this type of submission. This submission focuses on engineering, safety, and functionality verification.
Here's an analysis based on the information available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria and reported device performance in terms of diagnostic accuracy or clinical outcomes. The "acceptance criteria" discussed are related to the device's functional performance, safety, and substantial equivalence to a predicate device. The performance reported relates to the successful verification and validation of these functional aspects.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary of results) |
|---|---|
| Base movement speed functions as specified | Performed according to specifications |
| Scanogram functions as specified | Performed according to specifications |
| Axial/helical scan functions as specified | Performed according to specifications |
| Interlocks (e.g., contact detection) function as specified | Performed according to specifications |
| Complies with Quality System Regulations (21 CFR § 820) | Designed and manufactured under QSR and ISO 13485 |
| Conforms to applicable IEC standards (e.g., IEC60601 series) | Device conforms to specified IEC standards |
| Complies with radiation safety performance standards (21 CFR §1010, §1020) | Device complies with applicable radiation safety standards |
| Software functionality as specified (Moderate Level of Concern) | Software validation successfully completed |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This submission does not involve clinical data or "test sets" in the context of diagnostic algorithm evaluation. The "testing" refers to non-clinical bench testing, verification, and validation of the hardware and software components. Therefore, information about sample size for test sets (e.g., number of patients/cases), data provenance, or retrospective/prospective studies is not relevant or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. As this is a submission for a mechanical/electronic device modification and not a diagnostic algorithm, there is no "ground truth" to be established by clinical experts for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for the same reasons as above.
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 device is an optional physical kit for a CT system, not an AI or diagnostic algorithm, so no MRMC study or AI-assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware accessory (a self-propelled scan base kit), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" equivalent in this context would be the engineering specifications and safety standards against which the device's functional performance was verified.
8. The sample size for the training set
Not applicable. This document does not describe the development of a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there's no ground truth for it.
§ 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.