(24 days)
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform:
- Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
- Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally: - The Azurion series can be used in a hybrid Operation Room.
- The Azurion series contains a number of features to support a flexible and patient centric procedural workflow.
The Azurion R2.0 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Azurion R2.0 interventional fluoroscopic X-ray system include:
- Real-time image visualization of patient anatomy during procedures
- Imaging techniques and tools to assist interventional procedures
- Post processing functions after interventional procedures
- Storage of reference/control images for patient records
- Compatibility to images of other modalities via DICOM
- Built in radiation safety controls
This array of functions offers the physician the imaging information needed to perform minimally invasive interventional procedures. The Azurion R2.0 is available as a single monoplane (single C-arm) configuration of the currently marketed and predicate devices Azurion series R1.2 consisting of a FD20 (frontal channel) detector with a ceiling (Clea) geometry having a standard or OR compatible table. This can optionally be configured with a horizontal L-arm which provides an extra rotation axis, with re-designed motion control software providing patient and X-ray beam positioning movement and an improved 3D roll scan time. Additionally, identical to the predicate devices, Azurion R2.0 can be used in a hybrid operating room when supplied with a compatible operating room table, and can be optionally equipped with the ClarityIQ image processing algorithms.
The provided text describes the Philips Azurion R2.0, an interventional fluoroscopic X-ray system, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria with granular details like sample sizes for test and training sets, number and qualifications of experts, adjudication methods, or specific comparative effectiveness study results.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Azurion series R1.2) based on similarities in indications for use, technological characteristics, and non-clinical performance testing. It states that "the Azurion series R2.0 did not require clinical study data."
Therefore, I cannot provide a table of acceptance criteria with reported device performance, sample sizes, expert qualifications, or specific study design elements as these details are not present in the provided text.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that non-clinical performance testing "demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents" and "meets the acceptance criteria and is adequate for its intended use."
While specific numerical acceptance criteria (e.g., "accuracy > 95%") are not provided, the "acceptance criteria" implicitly refer to meeting the requirements of these standards and guidance documents. The "reported device performance" is that it complies with these standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Life Cycle Processes | Complies with IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). |
| Risk Management | Complies with ISO 14971 Medical devices Application of risk management to medical devices (Edition 2.0, 2007-03-01). |
| X-ray Tube Assemblies Safety & Performance | Complies with IEC 60601-2-28 - Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Edition 3.0, 2017-06). |
| X-Ray Equipment for Interventional Procedures Safety | Complies with IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.0, 2010-03). |
| Software in Medical Devices Premarket Submissions | Complies with Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005. |
| Substantial Equivalence Evaluation | Complies with Guidance for Industry and FDA Staff – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", July 28, 2014. |
| Functional & Non-functional Software Requirements | Software verification testing demonstrated all executed verification tests were passed. |
| Performance, Reliability & Safety | Software verification testing demonstrated all executed verification tests were passed. |
| User Needs, Intended Use, Claims, Effectiveness of Safety Measures & Instructions for Use | Non-clinical validation testing (including usability and simulated use studies) demonstrated all executed validation protocols were passed. |
| Commercial Product Claims | Simulated use study with interventional physicians substantiated commercial product claims. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document refers to "non-clinical performance testing," "software verification testing," and "non-clinical validation testing," including "simulated use environment" studies. No specific number of test cases, images, or subjects for these evaluations is given.
- Data Provenance: The studies are described as "non-clinical" and "simulated use," suggesting they were conducted in a controlled environment, likely by Philips Medical Systems Nederland B.V. The document does not specify the country of origin of data or if it was retrospective or prospective in detail. It does state that usability was performed with "interventional validation radiologists/cardiologists (physicians) and nurse/technicians in a simulated use environment." This indicates prospective data collection within the simulated environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document mentions "interventional validation radiologists/cardiologists (physicians) and nurse/technicians" participated in usability and simulated use studies. However, it does not state how many of each were involved or if they established a formal "ground truth" for a test set in the traditional sense of diagnostic accuracy. Their role was to validate the device's usability and conformity to intended use.
- Qualifications of Experts: "Interventional validation radiologists/cardiologists (physicians) and nurse/technicians." Specific experience levels (e.g., "10 years of experience") are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. The description of validation activities indicates that "participants executed validation protocols," and "all executed validation protocols were passed." This suggests a pass/fail assessment based on predefined criteria during the simulated use, rather than a conflict resolution/adjudication process for diagnostic ground truth.
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 Comparative Effectiveness Study: No. The document explicitly states: "The Azurion series R2.0 did not require clinical study data since substantial equivalence to the currently marketed predicate device Azurion series R1.1 was demonstrated..." There is no mention of an MRMC study or an assessment of human reader improvement with or without AI assistance. The device is an imaging system, and while it mentions "ClarityIQ image processing algorithms" can optionally be equipped, the focus of this submission is on the hardware and core software updates, not on a specific AI assistance feature for diagnostic improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable in the context of diagnostic accuracy for an algorithm. The device is an interventional fluoroscopic X-ray system, not a standalone AI diagnostic algorithm. Its "performance" refers to its compliance with technical and safety standards in a system context. Software verification testing was performed on "functional and non-functional requirements," which is a form of standalone testing for the software components, but not in the sense of a diagnostic accuracy study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the "non-clinical validation testing," the "ground truth" was effectively established by adherence to predefined "user needs, intended use, claims, effectiveness of safety measures and instructions for use." This is not a diagnostic ground truth (like pathology or outcomes data) but rather a validation that the system functions as intended and meets safety and usability criteria within a simulated environment.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes a medical device (X-ray system) and its software updates, not a machine learning model that would typically have a distinct "training set." The software components are verified and validated against specifications.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as this is not a machine learning model.
§ 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.