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The Angio Workstation is used in combination with an interventional angiography system (Infinix-i series systems and INFX-8000V and INFX-8000C systems) to provide 2D and 3D imaging and Dose Tracking System functions in selective catheter angiography for the heart, chest, and abdomen.

The XIDF-AWS801 Angio Workstatoin is a workstation for post-processing software that displays images in 2-d or 3-d format to provide additional information to the clinician. The software on this device remains unchanged with the exception of XIDF-DTS802 software.

The dose tracking system (DTS) is an application software package intended to provide the estimated dose distribution information during radiographic and fluoroscopic procedures. The dose tracking system (DTS) calculates the radiation dose of the patient's skin using the exposure technique parameters and exposure geometry obtained from the x-ray imaging system and presents the cumulative results in a color mapping on a 3D graphic of the patient model.

This 510(k) submission (K132106) describes a modification to the Toshiba XIDF-AWS801 Angio Workstation, specifically the addition of the XIDF-DTS802 Dose Tracking Software. The submission states that the added functionality does not change the intended use of the DTS and that the test methodology for verification remains unchanged from what was previously reported to the FDA (K123097). Therefore, the acceptance criteria and study details are primarily referred to in previous submissions.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the XIDF-DTS802. Instead, it refers to prior testing and general verification. The performance is summarized as follows:

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

• Sample Size: Not explicitly stated in this document. The testing involved "anthropomorphic phantoms and Lexan phantoms." The number of phantoms used or the quantity of data generated from them is not specified.
• Data Provenance: Not specified, but likely proprietary data generated by Toshiba America Medical Systems, Inc. through their testing. The document refers to "anthropomorphic phantoms and Lexan phantoms," indicating a laboratory testing environment rather than clinical data from human subjects.

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

• Not stated. The ground truth for dose estimation in phantom studies is typically established through direct measurement with dosimeters, which serve as the "true" dose for comparison. Clinical experts are usually involved in designing such studies and interpreting results, but their specific role in establishing the ground truth (i.e., the actual dose delivered to the phantom) is generally not as a human "reader" compared to imaging interpretation studies.

4. Adjudication Method for the Test Set

• Not applicable/Not stated. The testing methodology focuses on technical accuracy of dose estimation using phantoms rather than interpretation of clinical images by human readers requiring adjudication.

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

• No. This information is not mentioned in the document. The device is a dose tracking system, not an AI-powered diagnostic image interpretation tool that would typically undergo MRMC studies to assess reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, implicitly. The testing described as using "anthropomorphic phantoms and Lexan phantoms to verify and validate the performance of the system" to determine the "accuracy of the displayed estimated dose" refers to the standalone performance of the DTS algorithm. The "human-in-the-loop" aspect for a dose tracking system would typically involve the clinician observing the dose display during a procedure, but the accuracy validation itself is a standalone assessment of the calculated dose versus a measured dose.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the test set was based on measured radiation doses in anthropomorphic and Lexan phantoms. For dose estimation systems, physical measurements using calibrated dosimetry equipment (e.g., ionization chambers, thermoluminescent dosimeters) provide the ground truth for comparison.

8. The Sample Size for the Training Set

• Not specified. The document does not provide details about a distinct "training set" as one might find for a machine learning algorithm. The DTS calculates dose based on exposure parameters and geometry, which are physics-based models, not typically "trained" on a large dataset in the same way a deep learning model would be. Calibration and underlying physics models would be developed and validated, but a separate "training set" as defined for statistical or AI models is not indicated.

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

• Not applicable (based on the lack of a distinct "training set" as described above). The underlying models and calculations within the DTS would have been developed and verified through established physics principles and possibly empirical measurements, which serve as the foundation for the software's accuracy.

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