(279 days)
The Allura 3D-RA Rel. 6 is intended to assist physicians in analyzing two dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs. The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations. The Allura 3D-RA Rel.6 also supports measurement of lesion dimensions and anatomical distances.
The 3D Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
The MR-CT Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
The device description of the 3D Interventional Tools software medical devices that are subject of this 510(k) submission are as follows:
Allura 3D-RA Rel. 6 software medical device (Allura 3D-RA Rel. 6)
The Allura 3D-RA Rel. 6 is a software product (Interventional Tool) intended to provide high-speed and high resolution 3D visualization of vessels and bones anatomy. Allura 3D-RA is intended to be used in combination with an Allura X-ray system.
The Allura 3D-RA Rel. 6 generates a 3D reconstruction from 2D X-ray images to visualize vascular anatomy, and helps to identify vascular pathologies from a single contrast-enhanced rotational angiogram. It can be used during anv angiography procedure and can cover any anatomical area including cerebral, abdominal, and peripheral. It also allows for 3D visualization of the spine.
3D Roadmap Rel. 1 software medical device (3D Roadmap Rel. 1)
The 3D Roadmap Rel. 1 is a software product intended (Interventional Tool) to assist the physician during complex interventions by providing live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body. 3D Roadmap is intended to be used in combination with an Allura X-ray system.
The 3D Roadmap Rel. 1 overlays live 2D fluoroscopic images on a 3D reconstruction of the vessel tree processed by Allura 3D-RA Rel. 6 and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including cerebral, abdominal, and peripheral vasculature.
MR-CT Roadmap Rel. 1 software medical device (MR-CT Roadmap Rel. 1)
The MR-CT Roadmap Rel.1 is a software product intended to provide live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body, reusing segmented MRA or CTA data that has been acquired previously. The MR-CT Roadmap Rel.1 is intended to be used in combination with an Allura X-ray system.
The MR-CT Roadmap Rel.1 overlays live 2D fluoroscopic images on a previously acquired MRA or CTA volume, which is registered by the Allura 3D-RA Rel. 6 with the X-ray system using a rotational scan and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including for example cerebral, abdominal, and peripheral vasculature.
The 3D Interventional Tools software medical devices (Allura 3D-RA Rel. 6, 3D Roadmap Rel. 1, and MR-CT Roadmap Rel. 1) underwent verification and validation testing to ensure compliance with intended use, claims, requirement specifications, and risk management requirements.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Aneurysm tool success rate for segmentation: | Average success rate of segmentation: 73% with a 95% confidence interval of (60%, 100%] |
| Aneurysm detection capabilities: | Successfully used for aneurysms between 2 and 22 mm |
| Limitation: | Not suitable for aneurysms located on crossing vessels |
Study Details
-
Sample size used for the test set and data provenance:
- The study was a retrospective validation study performed on 3DRA clinical datasets with aneurysms. The exact number of datasets is not specified beyond "clinical datasets." The provenance (country of origin) of the data is not mentioned.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- Three experts were used to validate the performance of the aneurysm tool.
- One of the experts was an interventional neuro radiologist. The qualifications of the other two experts are not explicitly stated.
-
Adjudication method for the test set:
- The adjudication method is not explicitly described beyond stating that the performance was "validated by three experts."
-
Multi-reader multi-case (MRMC) comparative effectiveness study:
- No MRMC comparative effectiveness study is mentioned, or any effect size of human readers improving with or without AI assistance. The study focuses on the standalone performance of the aneurysm tool.
-
Standalone (algorithm only) performance:
- Yes, a standalone performance study was done for the aneurysm tool. The reported success rate of segmentation (73%) is the algorithm's performance.
-
Type of ground truth used:
- The ground truth was established by three experts, with one being an interventional neuro radiologist, based on 3DRA clinical datasets. This suggests an expert consensus/interpretation of the clinical data.
-
Sample size for the training set:
- The document does not specify the sample size used for the training set.
-
How the ground truth for the training set was established:
- The document does not specify how the ground truth for the training set was established. It only discusses the validation study and its ground truth.
§ 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.