(29 days)
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion PRIME 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.
The TSX-302A/2 is a 40-row CT System that is intended to produce axial scans of the whole body to include the head. The TSX-302A/2 is based upon the technology and materials of previously marketed Toshiba CT systems.
The provided text is a 510(k) premarket notification for a Computed Tomography (CT) system (TSX-302A/2, Aquilion Prime CT System). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not present in this type of FDA submission.
Here's an explanation based on the available information:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. A 510(k) submission for a CT scanner typically does not present quantitative performance acceptance criteria in the same way an AI/software device might. Instead, it focuses on demonstrating that the new device performs at least as safely and effectively as a legally marketed predicate device (substantial equivalence). Performance is generally shown through technical specifications (e.g., number of detector rows, dose reduction features, image reconstruction capabilities) being comparable to or improved over the predicate, rather than by meeting pre-defined statistical thresholds for diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided. Since this is a hardware device focused on substantial equivalence to a predicate CT scanner, there's no mention of a "test set" of patient data for evaluating diagnostic performance in the way an AI algorithm would be tested. The review primarily concerns the technical design and capabilities of the scanner itself.
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 Provided. As there is no test set of patient cases described for diagnostic evaluation, there is no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Provided. No test set, no adjudication method described.
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 / Not Provided. This device is a CT scanner, not an AI software intended to assist human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is a hardware CT scanner, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No ground truth is described for diagnostic performance evaluation. The "ground truth" for a CT scanner's performance would relate to its physical properties (e.g., spatial resolution, contrast resolution, noise, dose) which are assessed through engineering tests and phantom studies, not typically against medical "ground truth" in patient data for a 510(k) of this nature.
8. The sample size for the training set
- Not Applicable / Not Provided. This device is a CT scanner, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. No training set, no ground truth establishment for it.
Summary from the document:
The 510(k) for the Toshiba TSX-302A/2, Aquilion Prime CT System (K120410, later corrected to K120710 in the FDA letter) demonstrates substantial equivalence to its predicate device, the Toshiba Aquilion PRIME TSX-302A (K110066, or potentially k10066 as referenced in one section).
- Device Description: The TSX-302A/2 is described as a 40-row CT System intended to produce axial scans of the whole body, including the head. It's based on the technology and materials of previously marketed Toshiba CT systems.
- Intended Use: "This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Prime has the capability to provide volume sets. These volume sets can then be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician."
- Safety: The device is designed and manufactured under ISO-13485, meets 21 CFR 820 requirements, and conforms to appropriate IEC safety standards. Radiation safety adheres to 21 CFR 1020.
Conclusion:
This submission type (510(k) for a CT scanner) focuses on establishing "substantial equivalence" to a predicate device based on technical specifications, intended use, and safety standards, rather than proving performance against specific clinical acceptance criteria through a study involving patient data, expert reviews, and ground truth in the way an AI/software device would. Therefore, most of the detailed information requested about performance studies, sample sizes, and expert involvement is not present in this document.
§ 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.