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The AlluraClarity Xper FD Series X-ray System is 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, 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. .

Additionally:

• The AlluraClarity Xper FD Series X-ray System is compatible with a hybrid Operating -Room.
• FD10 is compatible with specified magnetic navigation systems.

The AlluraClarity Xper FD Series X-Ray System (AlluraClarity system) 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 AlluraClarity system can also be used for imaging in the Hybrid OR. The AlluraClarity system is provided with ClarityIQ technology, which utilizes the advanced XRES4 noise reduction algorithms to reduce quantum noise in X-ray images.

This device is an X-ray system, and the provided documentation focuses on its software validation and clinical performance based on questionnaires and dose reports, rather than a typical AI/ML-driven diagnostic device with specific performance metrics like sensitivity and specificity. Therefore, the questions related to ground truth, expert adjudication, MRMC studies, and separate training/test sets are not directly applicable in the conventional sense for this type of submission.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to "clinically acceptable" performance and successful utilization of the system for its indicated uses, as determined by physicians. There are no quantitative performance metrics such as sensitivity, specificity, or AUC provided in the document for the device's diagnostic capabilities, as the focus is on radiation dose reduction and image processing.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of images or cases. The clinical performance data is based on "retrospective collected and analyzed clinical data," specifically "DICOM structured dose reports and customer satisfaction questionnaires." The number of questionnaires or dose reports reviewed is not provided.
• Data Provenance: Retrospective clinical data. The country of origin is not specified, but the manufacturer is Philips Medical Systems Netherlands B.V., so the data could originate from various international sites where Philips systems are used.

3. Number of Experts and Qualifications for Ground Truth

This question is not directly applicable in the context of this submission. The "ground truth" here is the physician's subjective assessment of the system's clinical acceptability and utility, rather than external verification of a disease state.

• Number of "Experts": Not specified. The document mentions "all physicians indicated...", implying multiple physicians participated in the questionnaires, but an exact number is not given.
• Qualifications of "Experts": The "experts" are the physicians who utilized the AlluraClarity System during clinical procedures and completed the satisfaction questionnaires. Their specific qualifications (e.g., area of specialty, years of experience) are not detailed.

4. Adjudication Method for the Test Set

Not applicable. There was no formal adjudication process for a "test set" in the sense of verifying diagnostic accuracy or discrepancies between readers. The assessment was based on individual physician feedback via questionnaires.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe an MRMC comparative effectiveness study, nor does it quantify the improvement of human readers with or without AI assistance. The study focuses on the overall perceived clinical performance of the system as a whole, including its new image processing algorithms.

6. Standalone (Algorithm Only) Performance Study

No. The clinical performance data describes the performance of the integrated AlluraClarity Xper FD Series X-ray System, which includes the new image processing software (XRES4/ClarityIQ technology), not the algorithm in isolation.

7. Type of Ground Truth Used

The "ground truth" for the clinical performance assessment was expert consensus in the form of physician feedback/satisfaction questionnaires. This feedback directly addressed the "clinical acceptability" and "successful utilization" of the device for its indicated uses. While DICOM structured dose reports were also analyzed, they primarily provide objective data on dose, not clinical decision-making ground truth.

8. Sample Size for the Training Set

Not applicable. This device is an X-ray system with a new image processing algorithm, not a machine learning model that relies on a distinct "training set" in the conventional sense of supervised learning for classification or detection. The algorithms themselves would have been developed and tuned using various image data, but this is not characterized as a "training set" in the context of a clinical validation study's sample size.

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

Not applicable, as there is no mention of a distinct "training set" for the purpose of a clinical validation study with established ground truth. The XRES4 algorithms are described as "noise reduction algorithms," implying their development would involve signal processing and image quality metrics, rather than labeled clinical outcomes or pathology for training a diagnostic AI model.

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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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