(29 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, embolization 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 R8.2.1. The Allura Xper FD R8.2.1 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 R8.2.1 can also be used for imaging in the Hybrid OR. The Allura Xper FD R8.2.1 is optionally provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.
The provided text describes a 510(k) premarket notification for the Philips Allura Xper FD series and Allura Xper OR Table series (Allura Xper FD R8.2.1), an angiographic X-ray system. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study, especially in an AI context.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, experts, MRMC studies, standalone performance, ground truth types for AI models) are not explicitly provided in the document because it's a premarket notification for an imaging device, not an AI/CADe system.
However, I can extract the information that is present concerning performance, testing, and general equivalency.
Here's a breakdown based on the categories you requested, highlighting what is and isn't available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics for the device. Instead, it states that the device:
- "Complies with the aforementioned international and FDA-recognized consensus standards and/or FDA guidance documents"
- "Meets the acceptance criteria and is adequate for its intended use."
The performance described is primarily related to image quality demonstrating adequacy for neuroradiological procedures.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with international and FDA-recognized consensus standards (e.g., IEC 60601-2-43, IEC 60601-2-28, ISO 14971, IEC 62304) | The Allura Xper FD R8.2.1 complies with these standards. |
| Compliance with FDA Guidance Documents (Premarket Submissions for Software, General Principles of Software Validation, 510(k)s for Solid State X-ray Imaging Devices) | The Allura Xper FD R8.2.1 complies with these guidance documents. |
| Adequacy for intended use (producing images for medical procedures) | Sample clinical images demonstrate adequate quality for use in neuroradiological procedures. |
| Substantial equivalence to predicate devices in terms of design, functionality, indications for use, fundamental scientific technology, and performance specifications | The device is considered substantially equivalent to the predicate devices. |
| Proper introduction of modifications | System verification test was performed to ensure modifications are properly introduced. Verification and validation testing was conducted. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document only mentions "Sample clinical images" were included.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
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)
- Number of experts: One.
- Qualifications of experts: A "board certified radiologist." Specific experience (e.g., 10 years) is not mentioned.
- Role of expert: The radiologist provided a signed statement stating the images were of adequate quality.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/specified. The review was by a single board-certified radiologist, not an adjudication process among multiple readers to establish a formal ground truth requiring an adjudication method.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described that would involve human readers improving with or without AI assistance. This device is an X-ray system, not primarily an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to AI algorithm performance. Since no AI algorithm component is described for decision-making or diagnosis, a standalone algorithm performance study was not conducted or reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" concerning image quality was established by the subjective evaluation and statement of a single board-certified radiologist regarding the adequacy of the images for neuroradiological procedures. This is a form of expert opinion/evaluation, not a formal ground truth like pathology or outcomes data, which would typically be used for diagnostic accuracy studies.
8. The sample size for the training set
No training set is mentioned in the context of an AI/ML algorithm. The device is a hardware/software X-ray system.
9. How the ground truth for the training set was established
Not applicable, as no described training set for an AI/ML algorithm is present in the 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.