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Swissmeda Dental Planning System is intended for use by qualified dental professionals for Windows® based diagnostics and implant planning.

The software is an interface for imaging data that originates from medical scanners such as CT or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options.

Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

The planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning.

Swissmeda Dental Planning System is a stand-alone software device.

It is a Windows® based software application for the visualization of imaging information of the patient's mandible/maxilla region. It is intended to be used for diagnostics and a precise and reproducible pre-operative planning of dental implants and surgical treatment by aid qualified dental professionals.

Imaging data from medical scanners such as CT or DVT scanners (DICOM Standard) will be read in. The software calculates a volumetric (3 dimensional) data set which will be displayed in different windows: One shows the data as volume data where every voxel of the data set is shown with a grey value that defines the density of the bone substance. Three other windows show a slice through the 3d data set as a flat image. During a planning session the data can be stored to pause the planning session and can be reloaded to continue the planning session.

By inspection of the 3d information of the bone the dental professional can deduct hints where to place what kind of implants. To support planning the user is enabled to predefine a dental occlusion spline and an occlusion plane. He can select implants from a given implant catalog and insert them into the 3d data set at the predefined position given by the dental spline and the tooth number. The implant catalog contains real geometry of several implants from several different vendors. Swissmeda Dental Planning System has no limitations regarding material or surface types of implants.

For each patient several versions of the plan can be created, restored and exported each time.

The final planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick Dental GmbH* for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning during the surgery.

The provided text is a 510(k) K112251 submission for the Swissmeda Dental Planning System. This document focuses on establishing substantial equivalence to a predicate device based on intended use, features, and technological characteristics. It does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.

The document states, "The Swissmeda Dental Planning System is substantially equivalent to and performs as good as the predicate device coDiagnostiX® (K071636) based on the equivalence of the intended use, similar features and technological characteristics. Any differences between the devices do not raise new issues of safety and effectiveness." This implies that the 'study' for this submission is a comparison to a predicate device, rather than a de novo clinical trial with specific performance metrics defined by acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document as it relates to a different type of validation process.

However, I can extract the following based on the information provided:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics in this document. The primary acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate device, coDiagnostiX® (K071636).
• Reported Device Performance: The document claims the device "performs as good as the predicate device" based on "equivalence of the intended use, similar features and technological characteristics." No quantitative performance metrics like accuracy, sensitivity, or specificity are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable/not provided. This submission does not describe a clinical performance study with a test set of patient data. The evaluation is based on a comparison to a predicate device's features and intended use.
• Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/not provided. No ground truth establishment for a test set is described in this substantial equivalence submission.

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

• Not applicable/not provided. No test set or adjudication is described.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a "Dental Planning System," not an AI-assisted diagnostic tool for human readers in the typical sense of MRMC studies.

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

• The device is described as a "stand-alone software device" intended for use by "qualified dental professionals." While it operates independently in terms of processing imaging data, its output is for professional planning, implying human-in-the-loop decision making. However, no "standalone performance" study in the sense of a medical diagnostic algorithm's accuracy without a human is reported for this device's specific function (planning). The submission focuses on device features and equivalency.

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

• Not applicable/not provided. No clinical ground truth is established for a specific study in this document.

8. The sample size for the training set

• Not applicable/not provided. The document does not describe a machine learning algorithm that requires a training set. It is a software system for visualization and planning.

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

• Not applicable/not provided. As no training set is mentioned, no ground truth establishment for it is relevant.

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