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GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping , Systems.

GALILEOS Implant V1.7 is a pure software device. GALILEOS Implant V 1.7 is a planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. GALILEOS Implant V1.7 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of Implants to be placed in the patient's mandible/maxilla together with the related surgical procedures. The dental professionals' planning data may be exported from GALILEOS Implant V1.7 and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping Systems.

The provided document is a 510(k) summary for the GALILEOS Implant V 1.7 software. It describes the device's intended use and claims substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed performance metrics of the device itself.

The submission focuses on establishing substantial equivalence based on intended use, features, and technical characteristics, and mentions "Performance testing to validate the safety and effectiveness of the GALLEOS Implant V 1.7 system included validation testing and bench tests of the software functions." However, the results of this performance testing are not provided in this summary.

Therefore, I cannot provide the requested information. The document explicitly states:

• There is no table of acceptance criteria and reported device performance.
• There is no sample size used for a test set, nor data provenance.
• There is no information on the number or qualifications of experts used for ground truth.
• There is no adjudication method mentioned.
• There is no multi-reader multi-case (MRMC) comparative effectiveness study mentioned, nor any effect size.
• There is no standalone (algorithm only) performance study detailed.
• The type of ground truth used is not specified.
• There is no sample size for the training set.
• There is no information on how ground truth for the training set was established.

The document is a regulatory filing focused on establishing substantial equivalence, not a detailed technical report of performance studies.

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