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The Allura Xper FD X-ray imaging systems are indicated 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, embolisations 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. .

Combined with a qualified, compatible Operating Room (OR) table, the Allura Xper FD OR Table X-ray imaging systems can be used for imaging in the hybrid OR within the application domains neuro, vascular, non-vascular and cardiac. The OR table can also be used stand-alone for surgical use in the OR.

The proposed Allura Xper FD X-ray imaging systems with the SSD spacer removed are identical to the currently marketed and predicate Allura Xper FD X-ray imaging systems with the source-skin distance spacer (SSD spacer) mounted onto the X-ray tube housing, except that the SSD spacer is removed. Removal of the SSD spacer allows the execution of electrophysiology (EP) surgical procedures that require mounting of a special frame of currently marketed mapping systems (such as BioSense Webster's CARTO frame or Location Pad, etc.) underneath the patient table. With the BioSense Webster's CARTO frame mounted underneath the patient table, the SSD spacer mounted onto the X-ray tube housing of the currently marketed and predicate Allura Xper FD X-ray imaging systems interferes with the C-arc rotations during EP procedures, thus necessitating the removal of the SSD spacer. By construction, the source-skin distance cannot become smaller than 30 cm when the SSD spacer is removed. This minimum SSD complies with the international product safety standards IEC 60601-2-43 and IEC 60601-2-54 and with the minimum distance of 20 cm as required per 21 CFR, Part 1020.32(g) for certain specific surgical procedures.

This document is a 510(k) summary for a modification to an existing X-ray system, specifically the Allura Xper FD X-ray imaging systems with the SSD spacer removed. The core of the submission is to demonstrate that the modified device is substantially equivalent to its predicate device (the same system with the SSD spacer mounted). Therefore, the acceptance criteria and supporting "study" are primarily focused on proving this substantial equivalence, rather than establishing de novo performance benchmarks as a new device would.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a traditional "test set" with patient data in the way an AI algorithm submission would. Instead, the "test" is a technical comparison/analysis.

• Sample Size for Test Set: Not applicable in the context of imaging data. The evaluation is based on the system's design and mechanical/electrical components.
• Data Provenance: Not applicable. The "data" used for evaluation is primarily engineering specifications, design documentation, and regulatory standards. The submission highlights that the predicate devices are manufactured by Philips Medical Systems Nederland B.V. (The Netherlands).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. This is not a study requiring expert clinical assessment of images or outcomes to establish ground truth. The "ground truth" here is compliance with engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous clinical data requiring adjudication. The evaluation relies on direct comparison of technical specifications and regulatory compliance.

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 MRMC comparative effectiveness study was done. This device is an X-ray imaging system, not an AI-powered diagnostic tool intended to assist human readers. The change is a physical modification (removal of an SSD spacer).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not a standalone algorithm. It is a modification to a physical medical imaging device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Engineering Specifications and Design Intent: The manufacturer's assurance that the removal of the SSD spacer does not alter the performance of the core X-ray components (tube, collimator, detector, hardware, software).
• Regulatory Standards: Compliance with international (IEC 60601-2-43, IEC 60601-2-54) and US federal (21 CFR, Part 1020.32(g)) minimum source-skin distance requirements.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and does not involve a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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