(80 days)
The Philips Integris Allura Flat Detector release 1.0 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
The Philips Integris Allura Flat Detector release 1.0 system is an angiographic x-ray system with a solid state x-ray imaging device for cardiovascular diagnostic and interventional procedures. The monoplane system can be configured a either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cessium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on digital storage media, video or laser hardcopy.
The Philips Integris Allura Flat Detector release 1.0 is an angiographic x-ray system with a solid state x-ray imaging device. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a detailed study is not available in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The 510(k) summary focuses on general safety and effectiveness and substantial equivalence to a predicate device. It does not list specific quantitative performance acceptance criteria or report on device performance against such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The 510(k) summary does not describe any specific test set, its sample size, or data provenance for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. As no specific test set or ground truth establishment process is described, details about experts are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. No adjudication method is mentioned as there's no description of a test set and ground truth establishment.
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:
This information is not provided in the document. The device is an x-ray system, not an AI-powered diagnostic tool, and there is no mention of an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the document. The device itself is an imaging system, and the document focuses on its substantial equivalence and general safety, not on standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the document. There is no description of any ground truth being established for performance evaluation.
8. The sample size for the training set:
This information is not provided in the document. There is no mention of a "training set" as the device is an imaging system, not an AI model that undergoes training in this context.
9. How the ground truth for the training set was established:
This information is not provided in the document. No training set or its ground truth establishment is discussed.
Summary of available information:
The provided documents confirm the device's indications for use and its substantial equivalence to a predicate device (Philips Integris Allura 9 system with FD Option, K020055). The basis for clearance is that the device "does not introduce any new indications for use, nor does the use of the device result in any new potential hazard." The product is an angiographic x-ray system intended for cardiovascular x-ray imaging applications.
§ 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.