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510(k) Data Aggregation
(73 days)
Optional movable gantry base unit for use with the Aquilion LB CT Scanner to support the longitudinal movement and allow the acquisition of images in the z-direction (Z-axis).
This device is an optional kit that is attached to the gantry to provide z-axis image acquisitions, both axial and helical. When this option is selected the standard CT patient couch is replaced with a multipurpose patient handling system.
Here's an analysis of the provided text regarding the Toshiba Aquilion LB Movement Base Kit:
Acceptance Criteria and Device Performance Study for Toshiba Aquilion LB Movement Base Kit, CGBA-014B
Based on the provided K111633 submission, the Aquilion LB Movement Base Kit is a modification of a previously cleared device (TSX-201A, Aquillion LB CT Scanner (K050458)). As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo performance study with specific acceptance criteria as one might find for an entirely new algorithm or diagnostic device.
The core of this submission is that the modification (addition of an optional gantry moving base) does not affect the previously cleared indication for use or the safety and effectiveness of the underlying CT scanner. Therefore, the acceptance criteria implicitly align with maintaining the performance characteristics of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain the intended use of the Aquilion LB CT Scanner: The device must enable "scanning (including helical scanning) and scanoscopy... without patient couch movement." | "When this device is installed, scanning (including helical scanning) and scanoscopy can be performed without patient couch movement." |
| Maintain the safety of the Aquilion LB CT Scanner: The modification must not introduce new safety hazards or compromise existing safety standards. | "The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via an initial report." |
| Maintain substantial equivalence to the predicate device (Aquilion LB CT Scanner, K050458): The modification must not alter the fundamental technological characteristics or performance of the CT system in a way that raises new questions of safety or effectiveness. | "The Aquilion LB Movement Base Kit is an option that will be offered to customers that require this type of device. The change adds an optional gantry moving base and allows the removal of a dedicated CT Patient Couch. These changes do not affect the previously cleared indication for use for the Toshiba Aquilion LB CT Scanner (TSX-201A). Both devices are considered substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not detail a "test set" in the context of a clinical performance study with patient data. This is a technical modification rather than an imaging algorithm or diagnostic test. The evaluation for this 510(k) likely involved:
- Engineering bench testing and verification: To confirm mechanical functionality, electrical safety, and movement specifications.
- Compliance testing: Against relevant safety and performance standards (e.g., IEC60601-1, 21 CFR §1020).
- Comparison to the predicate device's established performance: Confirming that the addition of the movement base does not degrade image quality or other critical performance parameters of the CT scanner itself.
Therefore, there is no explicit sample size for a test set of patient data mentioned, nor is there information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a technical modification to a CT scanner base, rather than a diagnostic algorithm assessing medical images, there would not be a "ground truth" derived from expert review of patient cases in the traditional sense. The "ground truth" for this device would be its mechanical and electrical performance meeting engineering specifications and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is designed to evaluate the impact of a diagnostic device (often an AI algorithm) on human reader performance. This submission is for a mechanical/electrical modification to a CT scanner, not a diagnostic algorithm.
6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is hardware (a gantry movement base), not a standalone algorithm. Its "performance" is integrated into the overall CT system functionality.
7. The Type of Ground Truth Used
The "ground truth" for this device's approval is based on:
- Engineering specifications and measurements: Verifying the mechanical movement, stability, and electrical compatibility of the new base.
- Regulatory compliance: Demonstrating adherence to electrical safety standards (e.g., IEC60601-1) and radiation standards (21 CFR §1020).
- Substantial equivalence: The fundamental premise that the modification does not alter the established safety and effectiveness of the predicate CT scanner.
8. The Sample Size for the Training Set
Not applicable. This is a hardware modification, not an AI algorithm, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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