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The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).

When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angiography procedures for the heart, chest abdomen, pelvis and brain.

The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic lmaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

This document is a 510(k) premarket notification for the Toshiba Medical Systems Corporation's XIDF-AWS801, Angio Workstation, v5.31. It describes an update to an existing device rather than a de novo submission. Therefore, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the same way a new device with novel claims would.

However, based on the provided text, I can infer and extract some information relevant to your request, particularly regarding the additional software features introduced in this version (Left Atrium Segmentation, Parametric Images, and MAR – Metal Artifact Reduction). The document states that "Testing was performed using archived clinical images, simulation testing and bench (phantom) testing."

Here's an attempt to answer your questions based on the available information, noting where specific details are not provided in this 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the new software features. The overarching "acceptance criterion" for this 510(k) submission is that the modifications (new software features) retain the safety and effectiveness of the cleared predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the summary. The text mentions "archived clinical images" and "data sets."
• Data Provenance: The data used for testing included "archived clinical images" as well as "simulation testing and bench (phantom) testing." The country of origin for the clinical images is not specified. "Archived clinical images" suggests the data was retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the summary. Given the context of a 510(k) amendment for new software features that are "not intended for stand-alone use or diagnosis" but rather to provide "information that is to be used in adjunct to the normal images," it's possible that formal expert consensus for ground truth on a large test set was not a primary focus for this specific submission's documented testing, or the details were not included in the public summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the summary. The document focuses on the technical performance verification of the new features and their substantial equivalence, not on human reader performance with or without the device. The new software is explicitly stated as "not intended for stand-alone use or diagnosis" and is instead "to provide the user with information that is to be used in adjunct to the normal images."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, testing was done on the algorithms (the new software features). The summary states "Testing was conducted using bench (phantom) tests, simulations and archived images data sets. The results of this testing verified that the performance of the changes was within the specified requirements." This indicates a standalone evaluation of the software's output, as distinct from evaluating human performance. However, it also states the software is "not intended for stand-alone use or diagnosis."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The specific type of ground truth for the "archived clinical images" is not specified. For bench and simulation testing, the 'ground truth' would typically be defined by the known parameters of the phantom or simulated data.

8. The sample size for the training set

This information is not provided in the summary. The document mentions "archived clinical images" were used for testing, but it doesn't discuss a separate training set for the development of the algorithms.

9. How the ground truth for the training set was established

Since a training set size or its use isn't specified, how its ground truth was established is also not provided.

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The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).

When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angrography procedures for the heart, chest, abdomen, pelvis and brain.

The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic lmaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

Here's a breakdown of the acceptance criteria and study information for the XIDF-AWS801, Angio Workstation, v5.31, based on the provided FDA 510(k) summary:

This device (XIDF-AWS801, Angio Workstation, v5.31) is a modification of a previously cleared device (XIDF-AWS801, Angio Workstation w/Dose Tracking System, K132106). The changes are specifically related to the Dose Tracking Software, expanding it to provide estimated skin dose for the head and improving simultaneous tracking of dual tubes.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of specific numerical acceptance criteria (e.g., accuracy percentages, error margins) for the Dose Tracking System's performance in K141541. Instead, it states:

Key Observation: The summary focuses on verifying that the changes (expansion to head dose estimation and dual-tube tracking) perform as intended and do not negatively impact the established safety and effectiveness of the predicate device. There are no specific quantifiable performance metrics provided for the estimated dose compared to actual measured dose.

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

• Sample Size: Not explicitly stated. The document mentions "commercially available phantom and measurement tools" but does not quantify the number of phantoms, tests, or data points used in the testing.
• Data Provenance: The testing was "performed using commercially available phantom and measurement tools." This indicates that the data is prospective (generated specifically for this testing) and likely collected in a controlled laboratory or testing environment, rather than from patient data. The country of origin for the data is not specified, but the manufacturing site is in Japan (Toshiba Medical Systems Corporation).

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

• Number of Experts: Not applicable/Not stated. The ground truth for the dose estimation was established by "actual measured dose on the phantom within the gantry field of exposure," implying physical measurement rather than expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was based on physical measurements, not expert consensus 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

• MRMC Study: No. This device is a dose tracking system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The primary function is to provide an estimated skin dose for dose management.

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

• Standalone Performance: Yes, in essence, the testing described appears to be a standalone performance evaluation of the algorithm's ability to estimate dose against physical measurements. The "estimated dose displayed by the software" was compared against "actual measured dose on the phantom."

7. The Type of Ground Truth Used

• Type of Ground Truth: Physical measurement/reference standard. Specifically, the "actual measured dose on the phantom within the gantry field of exposure."

8. The Sample Size for the Training Set

• Sample Size: Not stated. The document describes a "modification of a cleared device" and implies that the dose tracking software is based on physical models and algorithms rather than machine learning that requires a "training set" in the traditional sense of AI. If machine learning was involved, this information is not provided. The testing focused on validating the modified software behavior.

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

• How Ground Truth for Training Set Was Established: Not applicable/Not stated. Given the nature of a dose tracking system, it's more likely based on established physics and calibration models than a "training set" with ground truth in the context of image recognition. If the original development of the dose tracking algorithms involved data-driven training, this information is not present in the provided summary focusing on the modification of an already cleared device.

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