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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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NemoCast is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned dectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment.

The use of the NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

NemoCast is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes STL Models (also called dental casts) for thermoforming aligners, STL files for direct printing aligners and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact.

This document (K232549) is a 510(k) premarket notification for the device "NemoCast," an orthodontic software. It establishes substantial equivalence to existing predicate devices, particularly 3Shape Ortho System™ (K152086) and a previous version of NemoCast (K193003).

The key takeaway is that this is primarily a software validation and substantial equivalency claim, rather than a study proving new clinical performance. The manufacturer is demonstrating that their current software performs similarly to a previously cleared version and a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and performance study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the typical format of a clinical study summary. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is the functionality of NemoCast itself, and the "study" is the comparison against the predicate devices.

The "Comparison of Intended Use and Technological Characteristics with the reference Device" table (pages 7-8) serves as the primary evidence of meeting "acceptance criteria" for substantial equivalence. It lists various features and functions, and for each, it aims to show "None" under "Differences" or a difference that does not affect safety and effectiveness.

Here's a condensed version of how that table functions as a de facto "acceptance criteria" and "performance report":

2. Sample size used for the test set and the data provenance

The document states: "The performance testing remains unchanged from the company's own reference device submission, NemoCast K193003. The performance testing for the subject device is being leveraged from the company's own reference device including: design verification and validation testing."

This implies that the sample size and data provenance for the current 510(k) submission are not new. They are relying on previous testing. The document does not explicitly state the sample size (number of cases/patients) or the data provenance (e.g., country of origin, retrospective/prospective) for the test set. This information would typically be found in the original K193003 submission or internal validation reports, which are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As this is a software substantial equivalence submission leveraging previous testing, details about the ground truth establishment for the test set (number and qualifications of experts) are not specified here.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a MRMC comparative effectiveness study demonstrating improved human reader performance with AI assistance was not done for this submission. The "NemoCast" device is described as a "medical front-end device providing tools for management... analysis, treatment simulation, and virtual appliance design." It is a planning and design software, not an AI-assisted diagnostic tool that would typically involve a human-in-the-loop MRMC study for assessing reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document mentions "The software is thoroughly tested in accordance with a documented test plan. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users." This general statement indicates functional and validation testing that would assess standalone performance (software functioning as intended). However, specific quantifiable metrics of "algorithm-only" performance (e.g., accuracy of automatic measurements) are not reported in this summary. The focus is on the functional equivalence of the tools provided within the software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of "ground truth" used for the underlying validation of the software's measurements or simulations. Given the nature of orthodontic planning software, ground truth for features like measurements or segmentations would typically be established through:

• Expert consensus: Manual measurements or segmentations performed by experienced orthodontists on 3D models.
• Physical measurements/phantom data: Validation against known physical dimensions or phantom models.

However, these details are not provided in this 510(k) summary.

8. The sample size for the training set

This information is not provided. As this is a software product, not necessarily one relying on a large deep learning model needing a defined "training set" in the context of AI development for image interpretation, this detail might not be applicable or explicitly stated. If there are features utilizing machine learning (which is not explicitly detailed but possible for functions like segmentation), the training set details are not included. The submission is focused on demonstrating functional equivalence.

9. How the ground truth for the training set was established

This information is not provided and is likely not applicable in the context of this 510(k) submission, as it focuses on demonstrating substantial equivalence of a software tool rather than a novel AI algorithm with a distinct training phase. If machine learning components exist, the process for establishing their "training ground truth" is not disclosed here.

In summary, the provided text details a 510(k) submission for substantial equivalence. It does not contain the detailed clinical study information (like sample sizes, expert qualifications, adjudication methods, or MRMC study results) that would typically accompany a submission for a novel diagnostic AI device where independent performance validation is the primary focus. Instead, it relies on demonstrating that the updated software (NemoCast K232549) is functionally equivalent to its predicate devices (NemoCast K193003, 3Shape Ortho System™ K152086) and that any differences do not impact safety or effectiveness.

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NemoCast is intended for supporting the diagnostic and treatment plan processes for orthodontic procedures related to minor anterior tooth movements; it provides tools for management of orthodontic models, systemic inspection, detailed analysis, treatment simulation and virtual appliance design options (export of models) based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied to evaluate if the outcome is consistent with the planned/desired treatment objectives.

NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

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I apologize, but the provided text from the FDA 510(k) clearance letter for NemoCast does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the level of detail requested.

The letter is a formal notification of substantial equivalence, and while it references the device and its indications for use, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or training sets.
• Data provenance (country, retrospective/prospective).
• Details about experts for ground truth establishment (number, qualifications, adjudication methods).
• Information about MRMC studies or effect sizes.
• Standalone algorithm performance data.
• Specifics on ground truth types or how it was established.

The document primarily focuses on the regulatory aspects of the clearance (e.g., product code, regulation number, substantial equivalence determination, general controls, and compliance requirements).

To answer your request thoroughly, I would need access to the full 510(k) submission, which typically includes detailed validation studies, performance data, and methodology. This information is not present in the provided FDA clearance letter.

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NemoFAB is a software indicated for supporting the diagnostic and treatment planning process of orthognathic procedures. NemoFAB is software that is also used as an image segmentation system and for the transfer of imaging information from a scanner such as a CT scanner. NemoFAB allows for the that can be transferred to a 3D printer for the creation of a splint, this splint will be used for aiding the surgeon in the placement of the bones in the orthognathic surgery according to the treatment plan.

Not Found

I apologize, but the provided text only contains an FDA 510(k) clearance letter and an Indications for Use statement for the NemoFAB device. It does not include information about the acceptance criteria, specific studies, or performance results of the device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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NemoScan is software indicated for supporting the diagnostic and treatment planning process for Dental Implantology. NemoScan is software that is also used as an image segmentation system and for the transfer of imaging information from a scanner such as a CT scanner.

Not Found

This is a 510(k) clearance letter for the NemoScan device, not a study report. Therefore, it does not contain the detailed information necessary to answer all questions regarding acceptance criteria and a study proving device performance in the requested format.

However, based on the provided text, I can infer some information:

1. A table of acceptance criteria and the reported device performance:

This document does not contain a table of acceptance criteria or reported device performance. It is a regulatory clearance letter, not a performance study report.

2. Sample sized used for the test set and the data provenance:

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the document. The device is described as "software indicated for supporting the diagnostic and treatment planning process for Dental Implantology" and an "image segmentation system," which suggests it might assist human readers, but an MRMC study and its results are not detailed here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not explicitly provided. Given its indication for "supporting" the diagnostic and treatment planning process and being "an image segmentation system," it's likely intended to be used with human oversight, but a standalone performance study is not described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the document.

8. The sample size for the training set:

This information is not provided in the document.

9. How the ground truth for the training set was established:

This information is not provided in the document.

In summary, the provided document is a regulatory clearance letter and does not include the detailed technical study information about acceptance criteria, test methodology, or performance metrics requested. These details would typically be found in the 510(k) submission itself, which is not publicly released in its entirety in this format.

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