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EP-Navigator is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live fluoro X-ray images of the same anatomy in order to support catheter/device navigation during specified procedures.

EP-Navigator image processing algorithms are executed on a PC based hardware platform, which can perform the following functions:

• segment previously acquired DICOM 3D CT image . data.
• superimpose the segmented 3D CT dataset on a live . fluoroscopic X-ray image of the same anatomy, obtained on a Philips Allura Xper FD angiography X-ray system.
• register the segmented 3D CT data with live . fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray sysem for specified procedures.

The provided text is a 510(k) summary for the Philips EP-Navigator. Unfortunately, this document does not contain the detailed study information or acceptance criteria typically found in a clinical validation report.

The 510(k) summary focuses on establishing substantial equivalence to legally marketed predicate devices, which means demonstrating that the new device is as safe and effective as existing devices. It primarily discusses:

• Device Description and Intended Use: EP-Navigator segments 3D CT images and superimposes/registers them with live fluoroscopic X-ray images for catheter/device navigation.
• Technological Characteristics: States that the device does not introduce new indications, has the same technological characteristics as predicates, and does not introduce new hazards.
• Predicate Devices: Lists several Philips imaging systems (CT, PET/CT, angiography) as predicate devices.
• Regulatory Information: Device classification, product code, and FDA communication.

To provide the detailed information requested in your prompt (acceptance criteria, study design, sample sizes, ground truth, MRMC study, etc.), a different type of document, such as a clinical validation report, performance testing report, or a more comprehensive technical summary, would be required.

Therefore, I cannot extract the specific information you asked for based on the provided text. The document confirms the FDA cleared the device based on substantial equivalence, but it does not delve into the granular details of performance validation studies.

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