(53 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-rav images. Combined with a qualified, compatible OR table, the Allura Xper FD series can also be used for imaging in the Hybrid Operating Room.
This document describes the Allura Xper FD series and Allura Xper OR Table series by Philips Medical Systems Nederland B.V., specifically focusing on the new marketing claim related to the ClarityIQ technology for neuroendovascular procedures.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The core claim pertains to radiation dose reduction while maintaining procedural performance. Therefore, the "acceptance criteria" can be inferred from the stated marketing claim and the study's primary and secondary endpoints.
| Metric (Acceptance Criteria / Claim) | Reported Device Performance (with ClarityIQ vs. without) |
|---|---|
| Primary Endpoints (Radiation Dose Reduction) | |
| Reduce patient dose (as dose-area product) in routine diagnostic neuroendovascular procedures. | Reduced patient radiation dose by 62% (95% CI of 56%, 68%) for the total procedure. |
| Reduce patient dose (as dose-area product) in routine interventional neuroendovascular procedures. | Reduced patient radiation dose by 65% (95% CI of 58%, 71%) for the total procedure. |
| Secondary Endpoints (Procedural Performance - No Detrimental Effect) | |
| Not affecting the procedural performance (fluoroscopy time) as compared to equivalent procedures on an Allura Xper system. | Did not affect procedural performances (fluoroscopy time). |
| Not affecting the procedural performance (number of DSA images) as compared to equivalent procedures on an Allura Xper system. | Did not affect procedural performances (number of DSA images). |
| Assess impact on performance of the physician (procedure time, number of acquired exposure images, number of acquired exposure runs). | The study aimed to assess this, and the conclusion states "...without affecting the procedural performances (fluoroscopy time and number of DSA images)..." implying no negative impact on these secondary endpoints. Specific values for these secondary endpoints are not provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Total eligible patients for analysis: 614
- Allura Xper (without ClarityIQ) group: 302 patients
- AlluraClarity (with ClarityIQ) group: 312 patients
- Data Provenance: Single center retrospective historically controlled cohort study from Karolinska Hospital - Solna, Sweden (outside the United States).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The study described is a retrospective historically controlled cohort study involving patient radiation dose and procedural metrics. The "ground truth" here is objective physiological and procedural data (radiation dose measurements, fluoroscopy time, number of DSA images, etc.) recorded during actual clinical procedures, rather than expert interpretation of images for diagnosis or outcomes.
- Number of Experts: Not applicable in the context of establishing a "ground truth" for image interpretation. The study collected quantitative procedural data.
- Qualifications of Experts: The study was conducted by an "interventional radiologist assisted by a physicist as necessary," but this refers to the appropriate settings for each clinical task, not for establishing a ground truth for the study's endpoints. The data itself (DAP, CAK, times, image counts) serves as the ground truth, presumably recorded by the angiography system and validated by standard hospital protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" consists of objectively measured and recorded clinical metadata (radiation dose, procedure times, image counts), not subjective interpretations 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, an MRMC study was not done. This study is an evaluation of the device's technical performance (dose reduction, procedural metrics), not an assessment of human reader performance or the impact of AI assistance on human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: Yes, in effect. The study directly measures the performance of the "AlluraClarity system with ClarityIQ technology" (an algorithm/system without human-in-the-loop performance measurement) compared to the "Allura Xper system" (without ClarityIQ). The "procedural performance" metrics (fluoroscopy time, number of DSA images) assess the impact of the technology on the procedure, not the human operator's diagnostic or interventional performance. The primary endpoints (radiation dose) are purely system performance metrics.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth consists of objective clinical (procedural) data for radiation dose metrics (DAP fluoroscopy, DAP exposure, DAP total, Cumulative Air Kerma) and procedural timing/imaging metrics (procedure time, fluoroscopy time, number of acquired exposure images, number of acquired exposure runs). This data was recorded during actual neuroendovascular procedures.
8. The Sample Size for the Training Set
- Sample Size for Training Set: The document does not provide information on the training set for the ClarityIQ technology. The ClarityIQ technology itself was cleared in K130638, suggesting its development and training (if applicable, for its noise reduction algorithms) happened prior to this specific 510(k) submission, which is about a new marketing claim for the already cleared technology within the Allura Xper system.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not specified in this document. As mentioned above, this 510(k) is for a new marketing claim for an already cleared technology (ClarityIQ). Information on the training of the ClarityIQ algorithms (if they are AI/ML based) would likely be in the K130638 filing.
§ 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.