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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 Aquilion ONE Vision, TSX-301C/1, v4.90 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.

The provided text is a 510(k) summary for the Toshiba Aquilion ONE Vision CT scanner. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new feature or algorithm. Therefore, many of the requested sections (sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth details, training set size) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications. The "acceptance criteria" here are implicitly that the new device meets or exceeds the performance of the predicate device for critical technical specifications, which in turn supports the claim that the indications for use and safety/effectiveness remain unchanged.

Table of Acceptance Criteria and Reported Device Performance

Summary of Changes:

1. Increased rotational speed from 350mS to 275mS.
2. X-ray Generator changed to match dose at new speed.
3. Tube has hardware enhancements to allow for higher rotational speed.
4. View rates have been increased.

Study Proving Device Meets Acceptance Criteria:

The submission does not describe a clinical study. Instead, it relies on technical testing and comparison to a predicate device to demonstrate substantial equivalence and adherence to safety standards.

• 17. TESTING: "Image Quality metrics utilizing phantoms are provided in this submission. Additionally, 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."

This indicates that internal performance testing, likely using phantoms, was conducted to verify the changes and ensure image quality, and that the system conforms to relevant IEC standards for safety and performance. The specific details or results of these phantom tests are not included in this summary.

Additional Information Not Available in the Provided Text:

2. Sample size used for the test set and the data provenance: Not applicable, as no human subject test set or clinical study is described. The performance data is derived from technical specifications and phantom testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no human subject test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a CT scanner, not an AI-powered diagnostic tool requiring reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The submission focuses on hardware and core software modifications of a CT scanner, not on a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the "ground truth" for this submission are the technical specifications and performance of the predicate device, against which the modifications are compared.
8. The sample size for the training set: Not applicable, as this is a CT scanner modification, not an AI model training.
9. How the ground truth for the training set was established: Not applicable.

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