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The IMPLANTER DENTAL PLANNING SOFTWARE is a device that employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and preplanning of dental implant surgery.

The Implanter Dental Implant Planning Software is a software aimed to help simplifying dental implant surgery and enhancing its mechanical and esthetic implications in the prosthetic stage. Implanter Dental Implant Planning Software allows dental implant professionals to plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will present the clinician with various reformatted CT/CBCT images of their patient's jaw(s), allow the placement and manipulation of virtual implants, and provide measurement and other tools to assist the clinician. Since the primary purpose of Implanter Dental Implant Planning Software is to aid the planning of implant surgeries, Implanter Dental Implant Planning Software will allow the surgeon to place simulated implants on the image and to gauge their size and position relative to the surrounding anatomy.

Implanter is a digital image processing software for Windows that loads images in DICOM format (CT and CBCT images) and rebuilds them in order to get different views that allows the dentist to assess the patient´s anatomy, plan a dental implant surgery, and design a printable surgical guide based on the former.

The software allows the dentist to:

• · use a dental virtual implant gallery to plan a surgery choosing the proper implant size. The IMPLANTER software contains a virtual dental implants library based on the Groovy Implants from Noble Biocare® (FDA cleared under K050258).
• Implanter Dental Planning Software generates 3D models and exports these . models in a format suitable for 3D printing to be used as physical models for visualization or educational purposes only. This clearance does not cover medical devices manufactured from those output files.
• save the surgical planning session of a patient for later analysis. .

The provided text is a 510(k) summary for the IMPLANTER DENTAL PLANNING SOFTWARE. This document indicates that clinical testing was not required for this 510(k) submission. Therefore, a study proving the device meets acceptance criteria via clinical performance data, as typically associated with a medical device approval and the type of information requested about sample sizes, experts, MRMC studies, and ground truth, is not provided or required in this submission.

The section "EFFECTIVENESS AND SAFETY CONSIDERATIONS" states:
Clinical Test: Clinical testing is not required.
Non-clinical Test: The IMPLANTER DENTAL PLANNING SOFTWARE has documented, validated and verified its software system. Performance tests have been conducted to verify equivalent performance to predicate devices. Performance tests include measurement accuracy of 3D and 2D measuring tools, nerve tracing and implant positioning, and implant drilling accuracy. Report generation has also been validated to verify accuracy of the information reported.

Based on the provided document, the assessment for substantial equivalence relies on non-clinical performance tests and a comparison of technical characteristics with predicate devices.

Here's a breakdown of the available information relevant to your request, noting where information is explicitly not provided due to the nature of this 510(k) submission:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the format typically used for clinical study outcomes (e.g., sensitivity, specificity, accuracy). Instead, it states that "Performance tests have been conducted to verify equivalent performance to predicate devices."

The non-clinical performance tests mentioned include:

• Measurement accuracy of 3D and 2D measuring tools
• Nerve tracing
• Implant positioning
• Implant drilling accuracy
• Report generation accuracy

No quantitative results from these performance tests are disclosed in the 510(k) summary. The comparison table focuses on features and technical specifications rather than specific performance metrics and their acceptance thresholds.

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

Not applicable/Not provided due to the absence of a clinical test. The non-clinical performance tests mentioned do not specify sample sizes for test cases or data provenance.

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

Not applicable/Not provided due to the absence of a clinical test that would typically involve expert assessment for ground truth.

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

Not applicable/Not provided due to the absence of a clinical test.

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

Not applicable/Not provided. The document explicitly states "Clinical testing is not required." This device is a preplanning software aid, and there's no indication of an MRMC study comparing human reader performance.

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

The device is described as "a software tool which serves as an aid to visualizing and preplanning of dental implant surgery." This inherently implies a human-in-the-loop scenario. The non-clinical performance tests focused on the accuracy of the software's tools (e.g., measurement, positioning) rather than autonomous diagnostic performance. No standalone performance metrics are provided.

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

For the non-clinical performance tests, implicit ground truth would be based on known geometric properties of test objects for measurement accuracy, or perhaps predefined anatomical references for nerve tracing and implant positioning. However, the exact methods for establishing this ground truth are not detailed in the summary.

Type of Ground Truth (for non-clinical tests): Not explicitly stated, but inferred to be based on predefined technical specifications or known values for the performance tests (e.g., actual distances for measurement accuracy tests).

8. The sample size for the training set

Not applicable/Not provided. This device is described as a "software tool" for planning, not an AI/ML device that requires a "training set" in the context of learning algorithms. It processes DICOM images and provides tools for user interaction. The summary does not mention any machine learning components that would necessitate a training set.

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

Not applicable/Not provided, as there is no mention of a training set for a machine learning algorithm.

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