(113 days)
This device is indicated to acquire and display cross sectional volumes of the whole 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/hardware, of the whole organ by a trained and qualified physician.
The Aquillion ONE Vision TSX-301C/1 and TSX-301C/Z, v6.00 is 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. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.
The provided text describes a 510(k) summary for the Aquilion ONE Vision CT scanner (K132222) and its modifications. However, it does not contain information about specific acceptance criteria or a study proving the device meets them with performance metrics related to diagnostic accuracy, sensitivity, or specificity.
The document states that the submission includes "summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met." It also mentions "successful completion of software validation" and compliance with various IEC, NEMA, and CFR standards.
This kind of 510(k) submission, particularly a "Special 510(k)" for modifications to a cleared device, often focuses on demonstrating that the changes do not adversely affect safety and effectiveness, and that the device still meets the performance specifications of the predicate device. It typically doesn't involve new clinical performance studies to establish acceptance criteria for diagnostic accuracy metrics in the same way a de novo device or a device with new clinical claims might.
Therefore, many of the requested categories related to clinical performance studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) cannot be extracted from this document as such studies are not described.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document refers to "requirements for the modifications" and "applicable standards" but does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or report device performance against such metrics. The changes are primarily technical (OS change, image quality improvements, dose reduction availability, addition of previously cleared software).
2. Sample size used for the test set and the data provenance
Not available in the provided text. The document mentions "bench testing" and "software validation" but does not specify a test set of patient data or its characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available in the provided text.
4. Adjudication method for the test set
Not available in the provided text.
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 mentioned. The device is a CT scanner, and the modifications are largely technical and do not appear to involve AI-assisted reading or a direct comparison of human reader performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not mentioned. The device is a CT scanner, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not available in the provided text.
8. The sample size for the training set
Not applicable/Not mentioned. There is no mention of a training set for an algorithm in this document. The "training" for a CT scanner typically refers to system calibration and quality control, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable/Not mentioned.
Summary of what the document DOES state regarding testing and safety:
- The device is designed and manufactured under Quality System Regulations (21 CFR § 820) and ISO 13485 Standards.
- It conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020].
- It complies with various IEC and NEMA standards (IEC60601-1 series, IEC60601-2-x series, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26).
- A "Special 510(k) submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met."
- "Software Documentation for a Moderate Level of Concern" was included.
- "Testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems."
- Conclusion: "Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use."
In essence, the document confirms that the modified CT scanner underwent rigorous engineering and software validation according to established industry standards and regulatory requirements, demonstrating that the modifications did not compromise the device's safety or effectiveness compared to the predicate device. However, it does not provide specific clinical performance metrics or studies as might be expected for an AI-powered diagnostic device.
§ 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.