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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):

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.

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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:

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.

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