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NemoScan is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scamers such as CBCT or CT scanners.

It is indicated for pre-operative simulation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step.

NemoScan software allows for surgical guide export to a validated manufacturing center or to the point of care.

Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.

NemoScan is intended to be used only for Adolescents (12-21 years of age) to adults (>21 years of age) patients.

NemoScan is a comprehensive diagnosis and treatment planning software for dental implantology intended to be used by dental professionals who have appropriate knowledge in surgical implantology and dental implants prosthesis. The software works with volume data sets imported from DICOM format produced by third-party CT/CBCT scanners and stored in a filedata repository. Additionally, optical scans of dental impressions can be imported from standard file formats like STL or PLY and registered over the volume to get reliable high definition of the anatomy of teeth and gums of the patients. The software is provided in three configurations: desktop, cloud and web.

Surgical planning is performed through convenient layouts of views, analysis of image data and the placement of virtual dental implants and optionally virtual prosthetic teeth. One patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan.

Additional functions are available to the user for refinement of the surgical planning, such as:

• Import, organize, store images from CT or CBCT in DICOM format (optionally if the case has these images, called Volume Images).
• Import digital impressions of the teeth (scanned stone models and intraoral scanner) and/or implant files in STL or PLY format, and align them over the volume image (if exists).
• Import facial scanner or 3D photos in OBJ or PLY format.
• Measurements of distances and angles in 2D, for slices, and 3D, for 3D views.
• Merge the dental digital impressions into the CT/CBCT patient volume.
• Do Orientation of the Volume according to the Natural Head Position of the patient (Reorient the 3D volume).
• Patient gums, teeth, bones, mandibular nerves and sinus segmentation to help the planner in viewing those anatomical conditions in 3D and their corresponding cross sections in the 2D slices.
• Possibility of simulation of teeth extractions for immediate implants placement.
• Specific layouts of views with the selected implant centered to accurately positioning the virtual implant according to the anatomical volume conditions.
• Bone densitometry with a density statistic for density measuring in the area around a distance outside and inside the limits of the positioned implant.
• Real time distances and angles to sensible areas like other implants, nerves, patient teeth, sinus, etc.
• Possibility of adding prosthetic teeth for designing the immediate loading prosthesis or just for helping in orienting the implants according to the prosthetic conditions.

NemoScan works with many manufacturers of implants, abutments, drills, analog, sleeves, hand pieces, etc., libraries to be used for simulation and treatment planning. The software allows importing these libraries and designing different kinds of surgical guides and immediate loading prosthesis to export the designed file in STL format. Finally, these designed files will be used to a validated manufacturing center or to the point of care.

The device has no patient contact nor does it control any life-sustaining devices.

The provided document is a 510(k) premarket notification letter and summary for the medical device NemoScan. It aims to demonstrate substantial equivalence to a predicate device.

However, the document states that "Although NemoScan (K192571) did not include exhaustive performance testing, the points Sterilization and Shelf Life, Biocompatibility, EMC and Electrical Safety are not applicable. NemoScan (K192571) included Labeling and verification and validation testing Report. The subject device NemoScan includes a performance testing report which justify the types of performance testing applicable to software as a medical device." and "A risk assessment has been performed based on FDA guidance, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Aug 2017" with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use of the new guides."

This indicates that the submission relies on a risk assessment and literature review rather than a specific study with defined acceptance criteria and reported device performance in the form requested. The document primarily focuses on establishing substantial equivalence through a comparison of technological characteristics with predicate and reference devices, and justification of software-specific performance testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a specific study, nor details about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The closest information available regarding "performance testing" are:

Non-Clinical Performance Data (Paragraph from page 7):
"Process performance qualifications of the manufacturing process are conducted to assure a guide of a certain material can safely and effectively be manufactured. Worst case testing of representative guide designs is utilized. Expected results are met. This process performance qualifications includes centralized manufacturing and point of care procedures. The validated materials and manufacturing processes are safe and effective for their intended use."

This describes a process performance qualification (PPQ) for the manufacturing of surgical guides enabled by the software, rather than a clinical performance study of the software itself. It confirms that the manufacturing process yields safe and effective guides but does not provide specific metrics for the software's clinical performance.

Type of Ground Truth Used:
The document does not explicitly state the ground truth used for any specific performance study of the NemoScan software. The "Non Clinical Performance Data" section refers to "validated materials and manufacturing processes" for surgical guides, implying an engineering or material science validation against established standards for those components. For the software itself, the substantial equivalence argument relies on a comparison of features and functionalities.

Training Set Information:
The document does not provide details regarding the sample size for a training set or how ground truth was established for a training set, as it does not describe a machine learning model or an AI-driven component with such requirements in the context of a performance study. The software is described as a "planning and surgery planning software tool."

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