(35 days)
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head.
The Aquilion 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-301Bis 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 is a 510(k) Pre-market Notification for the Toshiba TSX-301B Aquilion CT System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Therefore, the requested information, particularly regarding specific performance metrics, study designs, sample sizes, expert involvement, and ground truth establishment, is largely not available in this submission. This type of submission (a 510(k) for a modification to an existing CT system) typically does not include such rigorous clinical studies as it relies on the established safety and effectiveness of the predicate device.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness: Compliance with Quality System Regulations (21 CFR § 820) | "This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820." |
| Safety and Effectiveness: Compliance with Federal Diagnostic X-ray Equipment Standard (21 CFR § 1020.30 and 1020.33) | "All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device." |
| Safety and Effectiveness: Conformance with Medical Device Safety standards (IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44) | "Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-44. - Medical Device Safety standards." |
| Substantial Equivalence: Similar materials and processes to predicate device (TSX-301A/2 Aquilion ONE CT scanner) | "This device is similar in materials and processes to that of the predicate device, Toshiba TSX-301A/2 Aquilion ONE CT scanner." |
| Intended Use: Acquire and display cross-sectional volumes of the whole body, including the head | "This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head." |
| Intended Use: Capability to provide volume sets for specialized studies | "The Aquilion 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." |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The submission focuses on demonstrating substantial equivalence through compliance with regulations and technical standards and comparison to a predicate device, not through a clinical performance study with a test set. There is no mention of a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not explicitly stated. As there's no mention of a test set requiring ground truth establishment by experts for clinical performance, this information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set or associated adjudication method is 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. This submission is for a CT system, not an AI-powered diagnostic aide. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This document describes a CT system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical ground truth is described as part of this 510(k) submission. The "ground truth" implicitly referred to is the established regulatory compliance and performance of the predicate device and the new device's adherence to relevant technical standards.
8. The sample size for the training set
- Not applicable. This submission does not describe a machine learning algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned, this question is not relevant.
In summary: This 510(k) submission is for a modification to an existing CT system. The primary method of demonstrating acceptance criteria is by showing compliance with established regulations and safety standards, and by demonstrating substantial equivalence to a legally marketed predicate device. It does not involve a clinical study with a test set, training set, or expert-established ground truth in the way one would expect for a novel diagnostic device or AI application.
§ 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.