(155 days)
R2GATE is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CBCT scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment.
R2GATE is a web application and is intended for pre-operative planning to create and review plans for dental implant placement and surgical treatment, using MEGAGEN Implants. A dental implant plan can be edited with R2GATE Editor, a desktop software application, by a licensed dentist with clinical experience in implant surgery and medical image review.
The implant surgery plan can be used for manufacturing a surgical guide or for evaluation of treatment options by a licensed dentist.
Here's a summary of the acceptance criteria and study information for the R2GATE device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct, quantified table of acceptance criteria with specific numerical targets and the reported performance against those targets. Instead, it describes general categories of validation and verification performed and states that the "test results met the acceptance criteria and demonstrated equivalence."
However, based on the non-clinical performance data section, we can infer some criteria:
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Validation of CBCT data (Distance & Angle) | - Distance and angle values between R2GATE Windows and Blue Sky Plan were measured within the acceptable range. |
| Validation of CBCT data (Hounsfield Unit, HU) | - HU values between R2GATE Windows and Blue Sky Plan were measured within the acceptable range. |
| Verification of integrity of CBCT data (DICOM Image Data) | - No modification or conversion of the DICOM file between Blue Sky Plan and R2GATE Windows. |
| Verification of surgical guide model (Bonding/Precision) | - Differences in bonding or precision measurement between the design file (STL) and the actual structure were within the acceptable range. |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample size used for the non-clinical tests. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of the CBCT data used in the validation studies. It only mentions "Physical measurement values and numerical values (Hounsfield unit, HU) of distance and angle between specific points of CBCT data."
3. Number of Experts and Qualifications:
The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions that the R2GATE Editor is used by "a licensed dentist with clinical experience in implant surgery and medical image review," but this refers to the intended user, not necessarily the ground truth determiners for the validation study.
4. Adjudication Method:
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the effect size of human readers improving with AI vs. without AI assistance. The study focuses on comparing the subject device (R2GATE) to a predicate device (Blue Sky Bio Plan) based on technical performance and equivalence, not human-in-the-loop effectiveness.
6. Standalone (Algorithm Only) Performance:
The described "Non-Clinical Performance Data" and "Software testing" sections primarily relate to the standalone performance of the software in terms of data handling, measurement accuracy, and integrity. While the device is intended to be used by a dentist, the validation tests presented are focused on the software's inherent capabilities without explicitly detailing human-in-the-loop performance. Therefore, a standalone performance assessment akin to algorithm-only evaluation was performed for the features tested.
7. Type of Ground Truth Used:
The ground truth used appears to be a combination of physical measurements and comparative analysis with a legally marketed predicate device (Blue Sky Bio Plan).
- For CBCT data validation (distance, angle, HU), the ground truth seems to be derived from the inherent properties of the CBCT data and the measurements taken by both the subject and predicate devices, comparing their consistency.
- For surgical guide model verification, the ground truth would likely be the actual physical structure or a highly accurate reference model, against which the design file (STL) and actual manufactured structure are compared.
8. Sample Size for Training Set:
The document does not mention a training set sample size. This submission focuses on a Picture Archiving and Communication System (PACS) and pre-planning software, which typically relies on established algorithms for image processing and measurement rather than a machine learning model that requires a dedicated training set.
9. How Ground Truth for Training Set Was Established:
Since there is no mention of a machine learning component requiring a training set, the document does not provide information on how ground truth for a training set was established.
§ 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).