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The MedCAD® AccuPlan® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the MedCAD® AccuPlan® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial surgery. The surgical guides and dental splints are intended to be used for the maxillofacial bone in maxillofacial surgery. The MedCAD® AccuPlan® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The MedCAD® AccuPlan® System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy or stone castings made from the patient anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, dental splints, surgical guides, and patient-specific case reports.

Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), and/or 3-D scan images from patient physical models (stone models of the patient's teeth) to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. While the process and dataflow vary somewhat based on the requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.

The MedCAD® AccuPlan® System is made up of 4 individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), dental splints, surgical guides, and patient-specific planning reports for reconstructive surgery in the maxillofacial region.

The MedCAD® AccuPlan® System requires an input 3-D image file from medical imaging systems (i.e. - CT) and/or implant file. This input is then used, with support from the prescribing physician to provide the following potential outputs to support reconstructive surgery. Each system output is designed with physician input and reviewed by the physician prior to finalization. All outputs are used only with direct physician involvement to reduce the criticality of the outputs.

System outputs include:

• Anatomical Models
• Surgical Guides
• Dental Splints
• Patient-Specific Case Reports

The purpose of this submission was to add titanium cutting / drilling guides to the family of available patient specific outputs. Cutting and drilling instruments can only be used with titanium cutting / drilling guides. Polymer guides are to be used for marking and positioning of anatomy only.

The MedCAD® AccuPlan® System is cleared by the FDA as a software and image segmentation system for maxillofacial surgery. The primary purpose of this specific submission (K223024) was to add titanium cutting/drilling guides to the family of available patient-specific outputs, which were not part of the previous K192282 clearance.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance relies on performance testing to demonstrate substantial equivalence, particularly concerning the new titanium cutting/drilling guides. The document highlights two key performance tests:

The document also mentions:

• Sterilization Validation: In accordance with ISO 17665 and FDA guidance, to a Sterility Assurance Level (SAL) of 1x10^-6. All test method acceptance criteria were met.
• Biocompatibility Validation: In accordance with ISO 10993-1 and FDA guidance. Results adequately address biocompatibility for the output devices and their intended use.

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

• Wear Debris Testing: "Cutting / drilling instruments were used on a worst-case titanium surgical guide." The sample size is not explicitly stated but implies at least one worst-case guide was tested.
• Fit and Form Validation: "Subject devices from historical cases were manufactured." The sample size is not explicitly stated beyond "All samples met the predetermined acceptance criteria." The provenance is implied to be retrospective as it uses "historical cases." The country of origin of the data is not specified.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for these performance tests. The ground truth for the device's physical outputs (surgical guides) appears to be derived from engineered specifications and objective measurements (optical scanning, fit to master models). The system relies on trained MedCAD employees and physician input for planning, but this is part of the operational workflow rather than a ground truth establishment process for performance testing.

4. Adjudication Method for the Test Set

Not applicable. The performance testing described (wear debris, fit and form) does not involve human readers or a need for adjudication in the context of diagnostic agreement. It's a technical validation of physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was mentioned or performed. This device is described as a software system for planning and manufacturing physical outputs (guides, splints, models), which are then used in surgery, rather than an AI-based diagnostic tool that directly assists human readers in interpreting medical images for diagnosis. The system is operated by "trained MedCAD employees" and involves "clinical input and review from the physician during planning," but it's not described as an AI assistance tool for human interpretation of images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance tests described (wear debris and fit/form) evaluate the physical characteristics and dimensional accuracy of the manufactured outputs, which are direct results of the system's (algorithm's) processing and manufacturing. In that sense, aspects of "standalone" performance of the physical output are assessed. However, the system is explicitly stated as requiring "clinical input and review from the physician" for planning, meaning it's generally a human-in-the-loop system in its intended use, rather than a fully autonomous diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests appears to be:

• Engineered Specifications/Design Accuracy: For Fit and Form Validation, the manufactured devices are compared to the "3D model" (the digital design generated by the system based on patient imaging). This implies the 3D model itself serves as the ground truth for ideal form and alignment.
• Literature-based Safety Thresholds: For Wear Debris Testing, the acceptance criterion is quantitative: less than "that reported in the literature to be safe." This indicates a ground truth derived from existing scientific literature on safe levels of wear debris from similar materials/applications.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or "training data" for the MedCAD® AccuPlan® System. This suggests that the system's functionality is not based on a machine learning model that requires a training phase with labeled data in the way many AI/ML medical devices do. It appears to be a rule-based or engineering-based software for image processing, segmentation, and design for manufacturing.

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

Since no training set is mentioned (refer to point 8), this question is not applicable.

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