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510(k) Data Aggregation
(131 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. including diagnostic, 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. Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.
The Allura Xper family consists of the Allura Xper FD series and the Allura Xper OR Table series and is identified as Allura Xper FD R8.2. The Allura Xper FD R8.2 is a modular angiographic X-ray system, based on a set of components that can be combined into different single and biplane configurations to provide specialized angiography. Combined with a qualified, compatible OR table. the Allura Xper FD R8.2 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2 is optionally provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips Allura Xper FD series and Allura Xper OR Table series:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in the same way a de novo or PMA would. Therefore, explicit, quantifiable acceptance criteria with corresponding performance metrics are not detailed in this submission.
Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and guidance documents. The reported device performance is that it "Meets the acceptance criteria and is adequate for its intended use."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-43 (Medical Electrical Equipment - Specific Requirements for the Safety of X-Ray Equipment for Interventional Procedures) | Complies with IEC 60601-2-43 |
| Compliance with IEC 60601-2-28 (Medical Electrical Equipment - Specific Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis) | Complies with IEC 60601-2-28 |
| Compliance with ISO 14971 (Medical devices - Application of risk management to medical devices) | Complies with ISO 14971 |
| Compliance with IEC 62304 (Medical device software - Software life cycle processes) | Complies with IEC 62304 |
| Compliance with FDA Guidance document: "Guidance for the Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) | Complies with FDA Software Guidance |
| Compliance with FDA Guidance document: "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (January 11, 2002) | Complies with FDA Software Validation Guidance |
| Compliance with FDA Guidance document: "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" (August 6, 1999) | Complies with FDA Solid State X-ray Imaging Devices Guidance |
| Adequate for intended use | "Is adequate for its intended use" |
| Substantially equivalent to predicate devices in terms of safety and effectiveness | "Substantially equivalent to the currently marketed and predicate devices in terms of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, the Allura Xper FD R8.2, did not require clinical studies to support substantial equivalence."
Instead, "Sample clinical images that demonstrate diagnostic quality of the images are provided." This implies a limited, illustrative set of images rather than a formally sized test set for a performance study.
Therefore, for the device, there is no formally defined "test set" with a specified sample size or data provenance in the context of a clinical performance study. The data provenance for the "sample clinical images" is not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no formal clinical study with a dedicated test set and ground truth establishment was conducted for this 510(k) submission, this information is not applicable or provided.
4. Adjudication Method for the Test Set
As no formal test set and clinical study were conducted for this submission, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance
The document states that "The subject of this premarket submission, the Allura Xper FD R8.2, did not require clinical studies to support substantial equivalence." Furthermore, the device is an X-ray system with enhanced noise reduction (ClarityIQ technology), not an AI-assisted diagnostic tool for human readers in the typical sense of an MRMC study measuring reader improvement. Therefore, no MRMC comparative effectiveness study was done regarding human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is an angiographic X-ray system that produces images. The ClarityIQ technology utilizes "advanced XRES4 noise reduction algorithms" to improve image quality. While these are algorithms, the performance assessment described is in the context of the device producing diagnostically acceptable images, not a standalone diagnostic algorithm being evaluated for its own performance metrics (e.g., sensitivity, specificity). The focus is on the image quality produced by the system.
7. The Type of Ground Truth Used
Given that no formal clinical studies were performed for substantial equivalence and "sample clinical images" were provided to demonstrate "diagnostic quality," the concept of a formal "ground truth" as established in clinical trials is not directly applicable or described. The qualitative assessment of "diagnostic quality" would implicitly rely on expert interpretation, but the process is not detailed.
8. The Sample Size for the Training Set
The document mentions that the ClarityIQ technology utilizes "advanced XRES4 noise reduction algorithms." While algorithms often involve training data, the submission does not provide any information about the sample size used for the training set of these algorithms.
9. How the Ground Truth for the Training Set was Established
Similar to the above, since details about the training set are not provided, information on how its ground truth was established is not available in this document.
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