(27 days)
The Allura Xper R9 series (within the limits of the used Operating 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 Allura Xper R9 series can be used in a hybrid Operating Room. • The Allura Xper R9 series contain a number of features to support a flexible and patient centric procedural workflow.
The Allura Xper R9 is classified as an interventional fluoroscopic X-ray system. The primary performance characteristics of the Allura Xper R9 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 Allura Xper R9 is available in a comparable set of configurations for monoplane models as the currently marketed and predicate devices Allura Xper R9. Configurations are composed of detector type. (monoplane) geometry, table type and available image processing. The monoplane (single C-arm) systems are categorized into X-ray systems and the configurations are differentiated by the following features: - . 12 inch Flat detector (FD12) - 15 inch Flat detector (FD15) - 20 inch Flat detector (FD20) . Additionally, identical to the predicate devices, all configurations of the Allura Xper R9 are compatible for use 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 document is a 510(k) premarket notification for the Philips Medical Systems Nederland B.V. Allura Xper R9, an image-intensified fluoroscopic x-ray system. It describes the device, its indications for use, and a comparison to a predicate device.
However, the document states explicitly that "The Allura Xper R9 did not require clinical study data" (Page 7). This means the submission does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them from this document. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technological similarity rather than a clinical study.
Here's a breakdown of why the requested information cannot be fully provided:
1. A table of acceptance criteria and the reported device performance
- Not available in the document. The document states that clinical study data was not required. It relies on non-clinical performance testing and compliance with standards. No specific acceptance criteria or reported device performance from a clinical study are presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set or data provenance is mentioned as no clinical study was performed.
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)
- Not applicable. No clinical study was performed requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical study was performed 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
- Not available. The device is an X-ray system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware imaging system, not an algorithm being assessed for standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical study was performed requiring ground truth.
8. The sample size for the training set
- Not available/Applicable. The document does not describe a machine learning model or an algorithm that requires a training set in the context of clinical performance. The "2D Quantitative Analysis software" is mentioned as unchanged from a reference device and its details are not provided in terms of training.
9. How the ground truth for the training set was established
- Not available/Applicable. As no training set or clinical ground truth is described, this information cannot be provided.
In summary: The provided FDA 510(k) clearance letter and summary for the Allura Xper R9 demonstrate substantial equivalence based on non-clinical performance testing, technological characteristics, and compliance with recognized standards. It explicitly states that "The Allura Xper R9 did not require clinical study data." Therefore, the detailed information requested about acceptance criteria and clinical study results is not present in this document.
§ 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.