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The Allura Xper FD20 is intended for:

• · Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, " e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolyses.
• · Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP),
• Non-vascular interventions such as drainages, biopsies and . vertebroplasties procedures.

The Allura Xper FD20 is a stationary fluoroscopic angiographic X-ray system for vascular, neurovascular and cardiovascular procedures, as well as non-vascular procedures.

The provided text is a 510(k) summary for the Philips Allura Xper FD20, an X-ray system. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI/algorithm performance.

Therefore, I cannot fulfill your request as the required information is not present in the provided document.

The document primarily focuses on:

• Device Identification: Company name, device name (Allura Xper FD20), classification names.
• Predicate Device: Philips Integris Allura (K002016).
• Device Description: Stationary fluoroscopic angiographic X-ray system for vascular, neurovascular, cardiovascular, and non-vascular procedures.
• Intended Use: Specific applications like angiography, PTCA, stent placements, embolizations, thrombolysis, pacemaker implantations, and non-vascular interventions.
• Safety and Effectiveness: Compliance with regulatory standards (e.g., 21CFR, UL 2601-1, DICOM).
• Conclusion: The device is substantially equivalent to the predicate and introduces no new hazards or indications.

This is a typical 510(k) submission for an imaging hardware device, not an AI or algorithm-based software device, and therefore does not include the types of performance metrics and study details you've requested.

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