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IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of craniomaxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

IPS CaseDesigner has specific functionalities to visualize the diagnostic information, e.g. from CT-imaging, to perform specific measurements in the image data and to plan surgical actions in order to support the diagnostic and treatment planning process. Based on the diagnostic and planning data, the IPS design service can offer individualized surgical aids.

The IPS CaseDesigner 2.0 is a software and image segmentation system for the transfer of imaging information from a CT scanner, indicated to support the diagnostic and treatment planning process of craniomaxillofacial procedures and facilitate the service offering of individualized surgical aids.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly list quantitative acceptance criteria in a dedicated table format. The "Differences" section, however, outlines new functionalities and improvements compared to the predicate device, implying that the performance of these new features needed to be validated. The "Performance Data" section states that the device was verified and validated and that "requirements for the features have been met."

Based on the text, the key performance aspects that were likely evaluated for the new features are:

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the test set for any of the performance evaluations. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for any specific testing data.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. For the "New algorithm for virtual occlusion and occlusion alignment," it states "This algorithm was validated and it was concluded that it is as efficient and as accurate as the manual workflow..." but does not detail who performed this validation or how the "manual workflow" ground truth was established by experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. There is no mention of human readers improving with AI assistance or without. The device functions as a planning tool for clinicians, and the focus of the validation is on the accuracy and functionality of the software's new features.

6. Standalone Performance

Yes, the study primarily describes the standalone performance of the algorithm and software features. The validation of the "New algorithm for virtual occlusion and occlusion alignment" specifically states that it was concluded to be "as efficient and as accurate as the manual workflow," which implies a standalone assessment of the algorithm's output against a defined standard. The other listed features also focus on the core functionality of the software itself.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in detail for each feature. However, based on the description, it can be inferred that:

• Expert Consensus/Manual Workflow: For the "New algorithm for virtual occlusion and occlusion alignment," the ground truth likely involved a manual workflow of placing dental casts in occlusion and digitizing them, implicitly representing an expert-derived or standard clinical practice ground truth. The algorithm's output was compared against this.
• Engineering/Design Specifications: For functionalities like "Additional segmental maxillary osteotomies," "Osteosynthesis plates," "3D Cephalometry," and "Splint visualization," the ground truth for validation likely involved verifying the software's output against pre-defined engineering specifications, anatomical accuracy, and expected physiological movements/measurements as determined by medical and software experts during the design and development phases.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. As this device is a planning and visualization tool, rather than a deep learning model requiring extensive training data, explicit mention of a "training set" might not be applicable in the same way as for diagnostic AI algorithms. However, if any machine learning components were used (e.g., for occlusion alignment), this information is not provided.

9. How the Ground Truth for the Training Set was Established

Since the document does not specify a training set or its sample size, it does not describe how ground truth for a training set was established.

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IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

The IPS CaseDesigner software is a tool for the virtual planning of orthognathic surgery. The user is a (oral and maxillofacial) surgeon who needs to plan an orthognathic surgery, and will use the software to plan the osteotomy (bone cutting). This allows the surgeon to re-position the digitally cut pieces in the desired alignment and allows the visualization of how the patient aspect will look like, through soft tissue simulation. The software supports various types of osteotomy procedures (Le Fort I, Sagittal Split, Ramus and Chin).The selection of the appropriate osteotomy procedure for each patient case is at the discretion of the clinician.

The IPS CaseDesigner is a 3D image-based environment that allows the clinician to visualize a patient's anatomy. The creation of the 3D augmented patient model is derived from CBCT (Cone-Beam CT) data (DICOM). This allows the clinician virtually plan and simulate a craniomaxillofacial surgery. The IPS CaseDesigner software has the capability to save a surgical splint file that the clinician can send to the manufacturing facility for surgical splint creation based on the CBCT Data. The software does not have any functionality for designing.

The provided text describes the 510(k) premarket notification for the "IPS CaseDesigner" device (K161634). However, it does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets those criteria.

The document states:

• "Performance Data VII. The following performance data were provided or relied upon in support of the substantial equivalence determination."
• "Software Validation: Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"."

This indicates that performance data and software validation were submitted to the FDA, but the details of these tests, including specific acceptance criteria, sample sizes, ground truth establishment, or clinical study results (like MRMC studies or standalone performance), are not present in the provided excerpt.

Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. That information would typically be found in the detailed performance data or a separate study report, which is not included in this FDA 510(k) summary.

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