(84 days)
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).