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MedCAD® AccuPlan® Orthopedics 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 system and the result is an output data file. This file 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 of the fibula and ilium. surgical guides for harvesting bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults.

Device Description

The MedCAD® AccuPlan® Orthopedics System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support harvesting of bone to support maxillofacial reconstructive surgeries. The system uses electronic medical images of the patient's anatomy with input from the physician to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system include anatomical models, 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 Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during 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® Orthopedics System is made up of two individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical guides, and patient-specific planning reports for harvesting of bone from the fibula and ilium for use in maxillofacial reconstructive surgeries.

The MedCAD® AccuPlan® Orthopedics System requires an input 3-D image file from medical imaging systems (i.e., CT). This input is then used, with support from the prescribing physician to provide the following potential outputs to support maxillofacial reconstructive surgery. Each system output is designed with physician inout 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
Patient-Specific Case Reports

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MedCAD® AccuPlan® Orthopedics System, based on the provided FDA 510(k) summary:

This device is primarily a software system for surgical planning and the creation of physical outputs (anatomical models and surgical guides) based on CT scan data. The performance testing detailed here focuses on the physical outputs rather than an AI-driven diagnostic or assistive algorithm's accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Wear Debris Testing	The quantity and morphology of wear debris generated by the subject device under worst-case use conditions should align with values reported in the literature to be safe.	PASS: The quantity and morphology of wear debris generated by the subject device under worst-case use conditions aligns with values as reported in the literature to be safe.
Fit and Form Validation	All manufactured devices (anatomical models, surgical guides) must demonstrate verification of alignment with the 3D model (via optical scan) and successful fitting over the corresponding defect in a representative anatomical model.	PASS: All samples met the predetermined acceptance criteria.
Sterilization Validation	Achieve a Sterility Assurance Level (SAL) of 1 x 10⁻⁶	PASS: All test method acceptance criteria were met. (Performed in accordance with ISO 17665 and FDA guidance)
Biocompatibility Validation	Adequately address biocompatibility for the output devices and their intended use.	PASS: The results of the testing adequately address biocompatibility for the output devices and their intended use. (Performed in accordance with ISO 10993-1 and FDA guidance)
Pediatric Risk Analysis	Adequately address risks associated with the inclusion of the 12+ pediatric population.	A pediatric risk analysis was performed to support the change in patient population. (Implied Pass, as device was cleared)
Material & Geometrical Differences (vs. predicate)	Minor material and geometrical differences should not raise new questions for safety and effectiveness.	Performance testing demonstrates that the minor material and geometrical differences do not raise new questions for safety and effectiveness. (Implied Pass, as device was cleared)

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

Wear Debris Testing: Not explicitly stated, but "worst-case titanium surgical guide" indicates at least one such guide was tested.
Fit and Form Validation: "All samples" were tested. The exact number of samples is not explicitly stated.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, since the system processes patient-specific CT imaging, the "data" would be the CT scans themselves.

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

The document states that "The process requires clinical input and review from the physician during and prior to delivery of the final outputs" and "All outputs are used only with direct physician involvement to reduce the criticality of the outputs."
For the performance testing itself, the identity and number of "experts" (e.g., those determining if a fit was "PASS") are not specified. The ground truth for fit and form seems to be established by physical/optical measurement against a 3D model and representative anatomical model.
For the broader system design and physician input, "the prescribing physician" provides input and review, but their qualifications and number are not detailed beyond "physician."

4. Adjudication Method for the Test Set

No specific adjudication method (e.g., 2+1, 3+1 consensus) for the performance tests is described. The "PASS" result suggests a clear acceptance/rejection criteria was applied.
For the general operation of the system, it notes that 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." This implies an iterative, interactive process rather than a formal adjudication of a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not performed or described. The device is a surgical planning and manufacturing system, not an AI diagnostic aid evaluated for human reader improvement. The performance testing focuses on the physical properties and accuracy of the manufactured outputs.

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

The performance testing performed (wear debris, fit and form, sterilization, biocompatibility) relates to the outputs of the system (surgical guides, anatomical models) rather than the standalone algorithmic accuracy of image segmentation or planning.
The system itself relies on "trained MedCAD employees" and "clinical input and review from the physician." Therefore, it's not a purely standalone AI algorithm without human involvement in its operational workflow.

7. The Type of Ground Truth Used

For Fit and Form Validation: The ground truth appears to be the digital 3D model ("alignment with the 3D model") and a representative anatomical model ("fitting the guide over the corresponding defect"). These are objective measurements and physical fit evaluations.
For Wear Debris Testing: The ground truth for safety is published literature values of safe wear debris.
For Sterilization and Biocompatibility: Ground truth is established by international standards (ISO 17665, ISO 10993-1) and FDA guidance documents, which define accepted levels and methodologies.

8. The Sample Size for the Training Set

Not applicable / Not provided. This device is described as using "Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images." There is no mention of a machine learning model that requires a dedicated training set. The "software" component appears to be tools for engineers and physicians to interact with and refine 3D models.

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

Not applicable. As no training set for a machine learning model is mentioned, there's no ground truth establishment process to describe for a training set.

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