(169 days)
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.
| Feature / Criterion | Reported Device Performance |
|---|---|
| New Software Features | |
| Left Atrium Segmentation (automatic segmentation) | Testing (using archived clinical images, simulation, and bench testing) verified that the performance of the changes was within specified requirements and that the modifications retained the safety and effectiveness of the cleared device. (Specific quantitative performance metrics like accuracy, sensitivity, or precision are not provided in this summary.) |
| Parametric Images | Testing (using archived clinical images, simulation, and bench testing) verified that the performance of the changes was within specified requirements and that the modifications retained the safety and effectiveness of the cleared device. (Specific quantitative performance metrics are not provided.) |
| MAR (Metal Artifact Reduction) | Testing (using archived clinical images, simulation, and bench testing) verified that the performance of the changes was within specified requirements and that the modifications retained the safety and effectiveness of the cleared device. (Specific quantitative performance metrics are not provided.) |
| Overall Device Safety and Effectiveness | The device modifications do not change the indications for use or intended use. Safety and effectiveness have been verified via risk management and application of design controls. Testing has verified that the changes perform as intended and include user information related to their performance. The device is substantially equivalent to the predicate. |
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.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.