(295 days)
R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.
R2GATE Lite ™ allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).
The proposed device, R2GATE Lite ™ software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096).
The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.
R2GATE Lite TM let the user view, measure, zoom and rotate 2D and 3D images of dental implant plans generated by R2GATE Window (K190096). R2GATE Lite TM can be used by dental professionals as a patient consultation tool for planning dental implant surgery and treatment.
R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.
The provided text is a 510(k) summary for the R2GATE Lite™ device and does not contain the specific details about acceptance criteria, device performance, and the study methodologies typically found in a comprehensive clinical or performance evaluation report. The document primarily focuses on establishing substantial equivalence to a predicate device (R2GATE Windows).
However, I can extract and infer some information related to software testing and general claims.
Here's an analysis based on the provided text, with a clear indication of what is not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the R2GATE Lite™ device. It mentions "Software verification and validation was conducted to ensure the functionality and compatibility of all system components and to support the safety and effectiveness of the proposed devices." and "Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input."
This implies that the device met its functional and performance requirements as defined internally by the manufacturer, but these specific requirements and their numerical outcomes are not detailed in this summary.
General Software Functionalities (Implied Performance):
| Acceptance Criteria (Implied from Functional Description) | Reported Device Performance (Implied from V&V Statement) |
|---|---|
| Ability to view, measure, zoom, and rotate 2D and 3D images of dental implant plans. | Fulfilled (as per V&V statement) |
| Ability to review, revise, and approve implant surgical plans. | Fulfilled (as per V&V statement) |
| Compatibility with Windows PC, macOS, and Apple iOS tablet platforms. | Fulfilled (as per V&V statement) |
| Accurate creation of 3D nerve canal models from R2GATE Windows data. | Fulfilled (as per V&V statement) |
| Accurate import and use of scanned 3D models (STL files) for implant planning. | Fulfilled (as per V&V statement) |
| Ability to manipulate images on 2D or 3D screens. | Fulfilled (as per V&V statement) |
| Accurate measurement of angles and lengths on a 2D screen. | Fulfilled (as per V&V statement) |
| Functionality for adding, deleting, moving, and rotating implant models. | Fulfilled (as per V&V statement) |
| Functionality for adding, deleting, moving, and rotating anchor-pins. | Fulfilled (as per V&V statement) |
| Ability to view CT data from R2GATE Windows in axial, coronal, and sagittal images. | Fulfilled (as per V&V statement) |
| Functionality for enlarging/reducing, moving, and rotating 2D/3D views. | Fulfilled (as per V&V statement) |
| Ability to proceed with, save, or load existing projects created in R2GATE Windows. | Fulfilled (as per V&V statement) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for either training or testing data. The testing mentioned is "Software verification and validation," which includes unit tests, integration tests, system tests, and acceptance tests. These typically involve synthetic data, simulated scenarios, and potentially real patient data for validation, but the details are not provided.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for a 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. The device is a "pre-planning software" for dental implant placement and surgical treatment, and its primary function described is viewing, measuring, and approving plans generated by the predicate device (R2GATE Windows), suggesting a focus on functional equivalency rather than comparative clinical performance with human readers.
6. Standalone Performance Study
While the "Software verification and validation" (V&V) activities listed (Unit test, Peer Code Review, Integration test, Internal release test, Formal system test, Acceptance test) can be considered forms of standalone testing for the algorithm's functionality, the document does not detail a specific standalone performance study in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for any AI or algorithmic component, as the device is presented as an "image viewer" and "pre-planning software" that primarily interfaces with another cleared device (R2GATE Windows).
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given the device's function as a pre-planning and viewing tool for dental implants, ground truth would likely relate to the accuracy of measurements, correct rendering of 2D/3D images, proper display of generated nerve canal and implant models, and accurate application of revision/approval functions. This type of ground truth is often established through technical specifications and verification against expected outputs.
8. Sample Size for the Training Set
The document does not provide any information about a training set sample size.
9. How Ground Truth for the Training Set Was Established
The document does not provide any information about how ground truth for a training set was established.
In summary, the provided FDA 510(k) summary for R2GATE Lite™ focuses on demonstrating substantial equivalence through a comparison of intended use, indications for use, and functional descriptions with a predicate device. It indicates that software verification and validation activities were performed to confirm performance requirements were met, but it does not provide detailed quantitative performance metrics, study designs, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical or performance study report. This level of detail is often not required or included in the public 510(k) summary for certain device types, especially those classified as image management and processing systems.
§ 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).