(114 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 FD series / Allura Xper OR Table series R8.2.1. 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) summary for the Philips Medical Systems Nederland BV Allura Xper R9, an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a predicate device (Allura Xper FD series / Allura Xper OR Table series R8.2.1) rather than presenting a study to prove a device meets specific acceptance criteria based on its own reported performance.
Therefore, many of the requested elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set ground truth) are not detailed or applicable in the context of this 510(k) submission, which is primarily a comparative assessment.
However, I can extract the relevant information that is present:
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" in this context is substantial equivalence to the predicate device, specifically in terms of:
- Indications for Use: The modified device (Allura Xper R9) must have the same indications for use as the predicate.
- Technological Characteristics: Despite modifications, the fundamental scientific technology must be the same, and changes must not raise new questions of safety or effectiveness.
- Safety and Effectiveness: Performance testing (non-clinical) must demonstrate that the device is as safe and effective as the predicate device.
The "reported device performance" is a demonstration of this substantial equivalence.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Allura Xper R9 vs. Predicate) |
|---|---|
| Indications for Use | The rewording of the indications for use statement does not impact substantial equivalence because the indications for use of both devices remain exactly the same. |
| Technological Characteristics | The Allura Xper R9 has the same technological characteristics compared to the predicate devices. Modifications (e.g., different flat detectors, software architecture, user interfaces, hardware, operating system update) do not raise any new questions regarding safety or effectiveness. The fundamental scientific technology is the same. |
| Safety and Effectiveness | Non-clinical performance testing (software verification, usability, imaging performance) demonstrated compliance with International and FDA-recognized consensus standards and FDA guidance documents, and revealed equivalent imaging performance when compared to the predicate device. |
Other requested information:
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified for non-clinical performance tests. The document refers to "software verification testing," "non-clinical validation testing," and "imaging performance metrics" but does not detail sample sizes, data provenance (e.g., country), or whether it was retrospective/prospective outside of referring to "sample clinical images" which were not required for substantial equivalence.
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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 specified for the non-clinical performance tests that established substantial equivalence. The document mentions "Signed statements from a board certified radiologist demonstrate that sample clinical images are of adequate quality for use in diagnostic and interventional procedures." This was additional evidence, not the primary means of establishing substantial equivalence for the device's technical aspects.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. The non-clinical tests relate to engineering and technical performance (software verification, compliance with standards, imaging performance metrics). Expert adjudication in the traditional sense for diagnostic accuracy is not mentioned as a primary method for demonstrating substantial equivalence.
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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 MRMC study was done or reported. This device is an X-ray imaging system, not an AI-powered diagnostic tool. The submission is a 510(k) for an updated fluoroscopic X-ray system, demonstrating equivalence to an existing one.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of a general fluoroscopic X-ray system. The "standalone" performance here refers to the system's ability to capture and process images according to its specifications and regulatory standards. The non-clinical performance testing (software verification, imaging performance) served this purpose.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance tests, "ground truth" was established by compliance with recognized international standards (IEC, ISO), FDA guidance documents, and engineering specifications. For example, "Results demonstrated that all executed tests were passed" for software verification. "Equivalent imaging performance" was measured against the predicate device based on metrics outlined in specific FDA guidance.
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The sample size for the training set
- Not applicable. This submission is for an imaging device, not an AI/machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 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.