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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, usinq indicated software/hardware, by a trained and qualified physician.

The Aquilion LB, TSX-201A/3, v6.0 is a 40-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. This system is based upon the technology and materials of previously marketed Toshiba CT systems.

Here's an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Study Details for Aquilion LB, TSX-201A/3, V6.0

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary for the Toshiba Aquilion LB, TSX-201A/3, V6.0, primarily focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel performance claims against specific, quantitative acceptance criteria. Therefore, the "acceptance criteria" here are implicitly tied to maintaining or improving upon the performance of the predicate device and meeting general safety and image quality standards for CT systems.

- Spatial resolution 
- CT number 
- Contrast-to-noise ratio 
- Uniformity performance                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |

| Diagnostic Image Quality (Clinical) | - Representative diagnostic images (brain, chest, abdomen, peripheral exams) obtained using the subject device and reviewed by an American Board Certified Radiologist demonstrated that the device produces images of diagnostic quality and performs as intended. |
| Lung Volume Analysis Software Functionality | - Integration testing was conducted to verify that this application functions as intended on the Aquilion LB system. (Note: The algorithm itself was previously cleared and demonstrated accurate volume calculations using an electronic phantom, LungMan Phantom, and chest image datasets). |
| Safety and Regulatory Compliance | - Device designed and manufactured under Quality System Regulations (21 CFR § 820) and ISO 13485 Standards.

• Conforms to applicable parts of various IEC standards (e.g., IEC60601-1, IEC60601-2-44, etc.), NEMA standards (PS 3.1-3.18, XR-25, XR-26).
• Complies with all applicable requirements of radiation safety performance standards (21 CFR §1010 and §1020).
• Risk analysis and verification/validation testing conducted through bench testing demonstrates that the requirements for modifications have been met.
• Software Documentation for a Moderate Level of Concern per FDA guidance.
• Testing in accordance with applicable IEC standards. |

2. Sample Size Used for the Test Set and Data Provenance

Due to the nature of this 510(k) submission, which is for a modification of an existing CT system, the "test set" primarily refers to data used for phantom studies and representative clinical images rather than a large-scale clinical study with a specific patient sample size.

• Sample Size for Test Set:
  • Phantom Studies: Not explicitly quantified, but performed using "phantoms" for image quality metrics.
  • Clinical Images: "Representative diagnostic images" were obtained. The exact number of patients or images is not specified.
  • Lung Volume Analysis: Previously demonstrated using an "electronic phantom, LungMan Phantom and image data sets of the chest." The number of image datasets is not specified for this prior clearance.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document describes typical verification and validation activities for a medical device manufacturer. Given Toshiba Medical Systems Corporation is based in Japan and Toshiba America Medical Systems, Inc. is in the US, the testing could have occurred in either or both regions. The studies appear to be retrospective in the sense that they are conducted for verification and validation purposes after device modification, not as a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Clinical Image Review: "Representative diagnostic images, reviewed by an American Board Certified Radiologist."

  • Number of Experts: One ("an American Board Certified Radiologist").
  • Qualifications: American Board Certified Radiologist. No specific years of experience are mentioned.

• Phantom Studies and Detector Performance: Ground truth for these technical assessments is typically established by physical measurements and engineering specifications, not human experts.

• Lung Volume Analysis: The ground truth for the software's accuracy was previously established, at the time of K133715 clearance, using physical (LungMan Phantom) and electronic phantoms, for which the true volumes are known, and image datasets of the chest. The role of experts in establishing ground truth for these past tests isn't detailed in this document, but typically involves engineers/physicists for phantom assessments.

4. Adjudication Method for the Test Set

• Clinical Image Review: For the "representative diagnostic images," only one radiologist is mentioned as reviewing them. Therefore, an explicit adjudication method (like 2+1 or 3+1) involving multiple experts is not described for this specific part of the submission. The review likely served as a qualitative confirmation of diagnostic quality.
• Other Testing: Adjudication methods are not applicable to phantom studies or technical performance measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done according to this document. The submission focuses on demonstrating substantial equivalence of a modified device and its inherent performance, not on comparing human reader performance with and without AI assistance. The Lung Volume Analysis software is described as a post-processing application, but its impact on human reader effectiveness is not quantified in this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• Yes, for certain aspects.
  • Detector Performance and Image Quality Metrics (Phantoms): These are inherently standalone, algorithm-only, or device-only performance assessments. The device (Aquilion LB) is characterized directly.
  • Lung Volume Analysis: For the algorithm itself, its accuracy in volume calculations (part of its previous clearance, K133715) was demonstrated using an "electronic phantom, LungMan Phantom and image data sets of the chest," implying a standalone assessment of the algorithm's output against known values or established methods. The current submission only verified its integration and proper functioning on the Aquilion LB system.

7. The Type of Ground Truth Used

• Technical Specifications/Physical Measurements: For detector performance, spatial resolution, CT number, contrast-to-noise ratio, and uniformity. This ground truth is based on known physical properties of phantoms and calibrated measurement systems.
• Expert Consensus/Opinion (for Clinical Images): For the "representative diagnostic images," the "American Board Certified Radiologist" provided the ground truth (or confirmation) of diagnostic quality. This is an expert opinion-based assessment.
• Known Values (for Lung Volume Analysis): For the Lung Volume Analysis software, the ground truth was derived from known volumes in electronic and physical phantoms ("LungMan Phantom"). For "image data sets of the chest," the ground truth for actual volumes would likely have been established through a highly reliable method, possibly manual expert tracing on high-resolution images or comparison with other gold-standard volumetric methods (though not explicitly stated in this document).

8. The Sample Size for the Training Set

• The document does not provide information regarding a "training set" or its sample size. This is expected as the submission is for a modification to a cleared CT system, not for a de novo AI algorithm that requires extensive training data. The improvements and validations described pertain to hardware changes (new detector) and software integration, not to the development or retraining of a machine learning model.

9. How the Ground Truth for the Training Set Was Established

• As no training set is mentioned or implied, this question is not applicable based on the provided document.

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