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SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

This submission is a Traditional 510(k) for the Orthognathic wizard of SurgiCase software application.

SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

Based on the software planning several options are available to transfer the result of the planning to surgery. Examples:

• The software planning can be used to select appropriate implants or implant sizes for use during surgery.
• . Based on the planning, patient-specific surgical guides and implants can be designed.
• . Patient-specific surgical splints can be generated to transfer the planned dental occlusion to surgery.

The SurgiCase software platform is the basis of all clinical Materialise software designed for surgery planning. The platform allows basic functionality such as visualizing 3D objects, visualizing medical image data, generating 3D objects from medical image data and measuring.

On top of this platform, modules, also called wizards, can be added that each offer additional functionality such as planning a specific surgical routine. This platform is the main general wizard, while additional modules (wizards) are mainly based on the functionality of this general wizard; they assist the surgeon to plan specific surgery types step-by-step by providing each a different user interface, giving the surgeon the opportunity to fine tune parameters specific for that type of surgery. Current premarket notification is only for the Orthognathic wizard of the SurgiCase software. The rest of software wizards have been cleared under K073449 submission for the SurgiCase software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SurgiCase Orthognathic software wizard, based on the information available in the 510(k) summary:

Summary of Device Acceptance Criteria and Performance Data (Based on this 510(k) Pre-submission Documentation):

Based on the provided 510(k) summary, the device's acceptance criteria primarily revolve around its equivalence to its predicate device (SurgiCase, K073449) and successful completion of non-clinical software verification and validation. There are no explicit, quantifiable acceptance criteria or reported performance metrics in the provided text other than the successful completion of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information/Caveats: The document explicitly states that "Software verification and validation testing will be completed by the end of August 2011." While the FDA's clearance letter implies these were successfully completed and reviewed, the detailed reports themselves are not part of this public summary. Therefore, specific quantifiable acceptance criteria (e.g., accuracy, precision, processing time) and their corresponding performance values from these internal tests are not provided in this document. The "reported device performance" in the table above is inferred from the FDA's clearance.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document states the software uses "imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner," but does not mention the origin (country, specific hospitals) or nature (retrospective/prospective) of any specific data used for testing or validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

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:

• MRMC Study: No. The document explicitly states "Clinical testing: Not applicable." This indicates that no studies comparing human readers with and without AI assistance were conducted or submitted as part of this 510(k).

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

• Standalone Performance: The 510(k) summary only mentions "Software verification and validation testing." While these tests likely assessed the algorithm's performance in isolation (standalone), the specific details of these tests, including the metrics and results, are not provided in this document. The document primarily focuses on the regulatory submission process and substantial equivalence, not detailed technical performance studies.

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

• Type of Ground Truth: Not specified. Given the absence of detailed clinical or performance studies, the specific type of ground truth used for any internal software testing is not available in this summary.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified. This type of detail, if applicable to the software's development (e.g., for machine learning components, which are not explicitly mentioned but could be part of "image processing"), is not included in this 510(k) summary.

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

• Ground Truth for Training Set: Not specified.

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