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Rotograph EVO 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specially for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified healthcare professionals.

Rotograph EVO 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfil different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor, and image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique)) are performed via a computer.

This 510(k) summary does not contain the detailed information on acceptance criteria or a specific study proving device performance as requested. It is a general statement of substantial equivalence to predicate devices, focusing on the device's technical characteristics and safety/effectiveness rather than specific performance metrics and their validation.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided document.

Here's what the document does state regarding safety and effectiveness:

• Rationale for Substantial Equivalence: Rotograph EVO 3D has the same indication for use and technological characteristics as predicate devices (Villa Sistemi Medicali Rotograph EVO D (K090749) and Planmeca ProMax 3D (K060328)). Minor technological differences do not raise new questions regarding safety or effectiveness.
• Safety and Effectiveness Information:
  • The device labeling contains operating instructions for safe and effective use.
  • Software development followed documented processes for design, verification, and validation testing.
  • Final device validation and risk assessment were conducted to identify potential design hazards. Appropriate steps were taken to control identified risks.
  • The device was tested for compliance with IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety) and its derivatives.
• Conclusion: The device performs the same functions in the same environment as predicate devices, shares the same technology, is based on well-known technology, and is considered as safe and effective as the predicate devices, introducing no new potential safety risks.

The document indicates that the device has undergone testing for compliance with safety standards (IEC 60601-1) and that software development included verification and validation. However, it does not provide:

• Specific acceptance criteria with numerical targets.
• A description of a specific study to demonstrate performance against those criteria.
• Details on sample sizes, ground truth establishment, or expert involvement for performance validation.
• Information on MRMC studies or standalone algorithm performance.

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