(25 days)
The Allura Xper FD OR Table series is intended for use on human patients (within the limits of the used OR table) to perform:
• Vascular 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 electrophysiclogy (EP).
· Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures,
Combined with a qualified, compatible OR table, the Allura Xper FD 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 FD OR Table series is a modular X-ray systems series, based on a set of components that can be combined into different single and biglane configurations to provide specialized anglography. It is identical to the Allura Xper FD systems series, to which a qualified, compatible OR table component is added.
These Allura Xper FD OR Table series X-ray systems are Angiographic X-ray Systems consisting of 1 or more of the following components: X-ray generator, X-ray tubelhousing assembly, beam limiting device, image receptor. X-ray control, frontal/lateral stand, patient support and a monitor ceiling suspension.
The provided text describes a 510(k) submission for the Philips Allura Xper FD OR Table series, an angiographic X-ray system. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of algorithm performance or clinical effectiveness beyond general safety and equivalence to predicate devices.
The document focuses on non-clinical verification and validation testing to ensure the system functions according to specifications and risk management requirements, aligning with various IEC and ISO standards. It explicitly states: "No clinical performance test was required to show safety and effectiveness of the Allura Xper FD OR Table series in the intended clinical environment." This means there is no study described here that would provide the kind of performance metrics you've requested (e.g., accuracy, sensitivity, specificity, or human reader improvement with AI assistance).
Therefore, I cannot provide the specific information requested in your prompt regarding acceptance criteria and performance data for an AI/algorithm-based device, as this document is for an X-ray system hardware and software system and not an AI-powered diagnostic algorithm.
Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Inferred from standards compliance and substantial equivalence claim):
- Compliance with IEC 60601-1 (general safety), IEC 60601-1-1 (medical electrical systems safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation protection), IEC 60601-1-4 (programmable electronic systems), IEC 60601-2-7 (high voltage generators safety), IEC 60601-2-28 (X-ray source assemblies safety), IEC 60601-2-32 (associated equipment safety), IEC 60601-2-43 (interventional procedures X-ray safety).
- Compliance with IEC 62304 (medical device software life cycle processes).
- Compliance with IEC 62366 (usability engineering).
- Compliance with ISO 14971 (risk management).
- Functional verification and validation for intended use relative to internal specifications.
- Substantial equivalence in safety and effectiveness to predicate devices (Philips Integris Allura series, Philips Allura Xper FD10, Philips Allura Xper FD20, Siemens Axiom Artis, Siemens Artis Zee family, Siemens Artis Zee / Zeego family).
- Reported Device Performance: The document states, "Results of the conducted tests conclude that the Allura Xper OR Table series is substantial equivalent to its predicate device." No specific performance metrics (e.g., image quality measurements, diagnostic accuracy) are provided in this summary.
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 for a clinical performance study. The document states, "No clinical performance test was required." The "test set" for the non-clinical verification and validation would refer to technical test cases and scenarios, not patient data.
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 ground truth was established as no clinical performance study was conducted or required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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
- No, an MRMC comparative effectiveness study was not done. The device itself is an X-ray imaging system, not an AI-powered diagnostic tool intended to assist human readers in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an integral X-ray system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established or used for the purpose of a performance study. For non-clinical tests, ground truth would be based on engineering specifications and expected physical outputs.
8. The sample size for the training set
- Not applicable. This document pertains to regulatory approval for an X-ray system, not an AI algorithm trained on a dataset.
9. How the ground truth for the training set was established
- Not applicable. No AI algorithm training set is referenced.
§ 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.