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The Implant Location Software (ILS) is indicated for use by medically trained people as a software interface and image segmentation system for the transfer of imaging information from a CT scanner and as planning software for dental implant placement.

The Implant Location Software is a computer program (software) intended for use as an aid to the dental practitioners in the location of dental implants. The use as an all to the demal practitioners through the process through the process of Information bystem (120) gaan surgery. The system provides information but does not make any clinical decisions for the user.

The software is supplied on disk-on-key.

The Implant location Software is designed to use images acquired from The Implant Totation Boleval scanners, present a graphical image of the planned implants as "virtual implants" on the CT images using DICOM interface miplands, provide a summary report that gives planning information for the standards, provided buser to consult on-line views of the plan during operation.

The provided text is a 510(k) summary for the Implant Location Software (ILS) and a subsequent FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailing scientific study results.

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