(66 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 anglography procedures for the heart, chest, abdomen, pelvis, and brain.
The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.
The provided text describes a 510(k) premarket notification for the Toshiba Medical Systems Corporation's XIDF-AWS801 Angio Workstation, V6.10. This submission is for modifications to an already cleared device, primarily concerning the Parametric Imaging Function software. As such, the testing focuses on demonstrating that the modifications retain the safety and effectiveness of the cleared device, rather than proving the device meets new acceptance criteria for a novel indication.
Here's an analysis of the provided information against your requested points:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly define specific "acceptance criteria" in terms of quantitative performance metrics for the Parametric Imaging Function (e.g., a specific accuracy or sensitivity). Instead, the objective was to ensure the modified software functions correctly and does not compromise the cleared device's safety and effectiveness.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device." and "The modifications incorporated into the XIDF-AWS801, V6.10, do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications." |
| Correct Calculation/Display | "Validation and performance testing objective was to verify Parametric Imaging function correctly calculated and displayed the obtained parameter values, using testing conditions that were representative of clinical conditions using DSA image data." and "Validation and performance testing concluded the Parametric Imaging Function correctly calculates and displays the parameter values under clinical conditions. No limitations were observed based on these tests." |
| Performance within Requirements | "The results of this testing verified that the performance of the changes was within the specified requirements." |
| No Change in Intended Use | "The modifications incorporated into the XIDF-AWS801, V6.10, do not change the indications for use or the intended use of the 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: The document states that "Software verification and validation testing was conducted using archived image data sets." However, it does not specify the number of cases or images in this test set.
- Data Provenance: The data used was "archived clinical images." The country of origin and whether it was collected retrospectively or prospectively for testing purposes are not specified, though "archived" suggests retrospective use.
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)
The document does not mention the involvement of experts for establishing ground truth regarding the Parametric Imaging Function's calculations or display. The validation focused on the software correctly calculating and displaying parameter values, implying a comparison against expected computational outputs rather than expert interpretation of a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described for the test set.
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 MRMC comparative effectiveness study was done or mentioned. The device is an "Angio Workstation" with a "Parametric Imaging Function" that "provides the user with information that is to be used in adjunct to the normal images provided by the Angio System" and is "not intended for stand-alone use or diagnosis." This indicates it's an assistive tool, but its impact on human reader performance was not quantified in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states, "Parametric Imaging is intended for use with existing imaging from the cleared device. The software is not intended for stand-alone use or diagnosis." This explicitly indicates that no standalone performance study was conducted or intended for the Parametric Imaging Function in a diagnostic context. The testing focused on the correct calculation and display of parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the testing primarily revolved around verifying the "Parametric Imaging function correctly calculated and displayed the obtained parameter values." This suggests the ground truth was computational accuracy – comparing the software's calculated parameter values against reference or expected values based on the input DSA image data, rather than a clinical ground truth like pathology or expert diagnosis.
8. The sample size for the training set
The document does not mention a training set as the submission is for modifications to a cleared device and the testing focuses on validation of the modified software's functionality, not on training a new AI model from scratch. The Parametric Imaging Function appears to be based on pre-defined algorithms rather than a machine learning model requiring a training phase for this specific modification.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of these modifications, the question of how its ground truth was established is not applicable here.
§ 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.