(51 days)
The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform:
· Vascular, cardiovascular and neurovascular imaging applications, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis.
· Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP).
· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
Additionally:
· The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.
- · Allura Xper FD10 is compatible with specified magnetic navigation systems.
· Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.
The Allura Xper FD series and the Allura Xper OR Table series is a modular angiographic X-ray system, which is based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. The Allura Xper FD series and the Allura Xper OR Table series provided with optional ClarityIQ technology (cleared in K130638) utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images. Combined with a qualified, compatible OR table, the Allura Xper FD series can also be used for imaging in the Hybrid Operating Room.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Allura Xper FD series and Allura Xper OR Table series with ClarityIQ technology
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Primary Endpoints (Radiation Dose Reduction) | |
| Reduce patient radiation dose (total dose-area product) by 67% for total procedure in routine coronary procedures. | Patient radiation dose was reduced by 67% (95% CI of 53%, 77%) over the total procedure. |
| Secondary Endpoints (Procedural Performance) | |
| Not affecting procedural performance (fluoroscopy time) | Fluoroscopy time was consistent between the systems. |
| Not affecting procedural performance (number of exposure images) | Number of exposure images was consistent between the systems (though an increase in AlluraClarity was attributed to biplane vs. monoplane configuration). |
| Not affecting procedural performance (number of exposure runs) | Number of exposure runs was consistent between the systems (though an increase in AlluraClarity was attributed to biplane vs. monoplane configuration). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 122 patients (80 for AlluraClarity system, 42 for Allura Xper system) were evaluable for radiation dose analysis out of 127 randomized patients.
- Data Provenance: Prospective, controlled, randomized single-center study conducted at University Hospital Gent, Belgium.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set beyond the general context of the "interventional cardiologist assisted by a physicist." This study primarily focuses on quantifying dose reduction and procedural performance, which are objective measurements rather than subjective interpretations by multiple experts. The "ground truth" here is the objective measurement of radiation dose (DAP, CAK) and procedural metrics like fluoroscopy time and image count.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Since the primary endpoints are objective measurements (radiation dose, fluoroscopy time, etc.), a formal adjudication process (like 2+1 or 3+1) for subjective interpretations would not be applicable or necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the device's technical performance in terms of dose reduction and procedural metrics, not on human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
The study assesses the performance of the "AlluraClarity system with ClarityIQ technology" which utilizes advanced XRES4 noise reduction algorithms. While it is implied the algorithm is functioning "standalone" from a human interpretational perspective, the study is comparing this system (used by interventional cardiologists) against an older system. The direct performance of only the algorithm's output quality (e.g., image clarity metrics) without human interaction is not explicitly detailed as a primary outcome. However, the study aims to show that the dose reduction achieved by the algorithm does not negatively impact procedural performance, indirectly addressing the algorithm's effectiveness in a clinical workflow context.
7. Type of Ground Truth Used
The ground truth used consists of objective physiological measurements and procedural metrics:
- Radiation dose measurements: Cumulative Dose Area Product (DAP) fluoro, DAP exposure, DAP total (sum of DAP fluoro and DAP exposure), and Cumulative Air Kerma (CAK) values. These were collected from Radiation Dose Structured Reports and/or Allura Reports.
- Procedural metrics: Procedure time, fluoroscopy time, number of acquired exposure images, and number of acquired exposure runs.
8. Sample Size for the Training Set
The document does not specify a separate training set for the ClarityIQ technology. The study described is a clinical study to validate the dose reduction claim, not a study for training the algorithm itself. The ClarityIQ technology with its XRES4 noise reduction algorithms was previously cleared (K130638), implying its development and potential training were done prior to this specific study.
9. How the Ground Truth for the Training Set Was Established
Since no training set is explicitly mentioned or detailed in this document, the method for establishing its ground truth is not provided. The "ground truth" in this context refers to the basis for the clinical claim being made using the already developed ClarityIQ technology.
§ 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.