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The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.

The Philips Integris Allura Flat Detector release 1.2 system is an angjographic x-ray system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintilator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on digital storage media, video or laser hardcopy.

This document (K031333) is a 510(k) summary for the Philips Integris Allura Flat Detector release 1.2 system. It states the device's intended use and declares substantial equivalence to predicate devices. However, this document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader comparative effectiveness studies.

The information provided focuses on regulatory aspects, such as:

• Company Information: Philips Medical Systems North America Company
• Device Name: Philips Integris Allura Flat Detector release 1.2 system
• Classification Name: Angiographic x-ray system, Solid x-ray Imager
• Predicate Devices: Philips Integris Allura Flat Detector release 1.0 system (K022899) and GE Innova 4100 system.
• Device Description: Angiographic x-ray system with a solid-state flat dynamic x-ray detector (amorphous silicon with a cesium iodide scintillator) for cardiovascular and vascular diagnostic and interventional procedures.
• Indications for Use: Cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
• General Safety and Effectiveness: Compliance with 21CFR, Subchapter J - Radiological Health, parts 1020.30, 32 and 1040.10, UL 2601-1, and ACR/NEMA DICOM standard.
• Conclusion: Substantially equivalent in safety and effectiveness to predicate devices.

Therefore, based solely on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria and study details. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

To answer your questions, I would need a different type of document, such as a clinical study report, a detailed design validation report, or the relevant sections of the predicate device's 510(k) submission if the performance claims are based on that.

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