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.

Summary

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September 20, 2023

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

MedCAD % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188

Re: K223421

Trade/Device Name: MedCAD® AccuPlan® Orthopedics System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF, LLZ Dated: August 18, 2023 Received: August 18, 2023

Dear Mr. Gracyalny:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223421

Device Name MedCAD® AccuPlan® Orthopedics System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K223421 510(k) Summary MedCAD® AccuPlan® Orthopedics System

September 18, 2023

Sponsor

MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 (214) 453-8864 x305

Contacts

Secure BioMed Evaluations Justin Gracyalny, MSE Linda Braddon, Ph.D. 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory(@SecureBME.com

Name of Device and Classification Name

Device Name: MedCAD® AccuPlan® Orthopedics System Common Device: Orthopaedic Surgical Planning And Instrument Guide Regulation Name and Number: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 892.2050 Medical image management and processing system Product Code: PBF, LLZ Classification Panel: Orthopedic

Predicate Device CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614)

Reference Devices MedCAD® AccuPlan® System (K192282 / K223024)

Indications for Use:

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.

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K223421

Device Description

System outputs include:

Anatomical Models ●
Surgical Guides
Patient-Specific Case Reports ●

Sterilization Validation

Sterilization validation was conducted in accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." to a sterility Assurance Level (SAL) of 1x10 . All test method acceptance criteria were met.

Biocompatibility Validation

Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the output devices and their intended use.

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K223421

Performance Testing

Performance testing for the MedCAD® AccuPlan® Orthopedics System is summarized in the table below:

Test	Test Method Summary	Results
Wear DebrisTesting	Cutting / drilling instruments were used on aworst-case titanium surgical guide. The quantityof wear debris generation was characterized.Wear particles were characterized per ASTMF1877-16.	PASSThe quantity andmorphology of weardebris generated by thesubject device underworst case useconditions aligns withvalues as reported in theliterature to be safe.
Fit and FormValidation	Subject devices were manufactured from worst-case CT scan input data. The manufactureddevices were optically scanned to verifyalignment with the 3D model. Evaluation of fitwas also validated by fitting the guide over thecorresponding defect in a representativeanatomical model.	PASSAll samples met thepredeterminedacceptance criteria.

Substantial Equivalence

MedCAD® AccuPlan® Orthopedics System is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, and outputs.

Property	MedCAD® AccuPlan®Orthopedics System	CenterMed Patient MatchedAssisted Surgical Planning (ASP)System
510(k) number	K223421	K211614
Indications for Use	MedCAD® AccuPlan® OrthopedicsSystem is intended for use as asoftware system and imagesegmentation system for the transferof imaging information from amedical scanner such as a CT basedsystem. The input data file isprocessed by the system and theresult is an output data file. This filemay then be provided as digitalmodels or used as input to a rapidprototyping portion of the system thatproduces physical outputs includinganatomical models of the fibula andilium, surgical guides for harvesting	CenterMed Patient Matched AssistedSurgical Planning (ASP) System isintended for use as a software systemand image segmentation system forthe transfer of imaging informationfrom a medical scanner such as a CTbased system. The input data file isprocessed by the ASP system and theresult is an output data file. This filemay then be provided as digitalmodels or used as input to a rapidprototyping portion of the system thatproduces physical outputs includinganatomical models of the Fibula andIlium, surgical guides for harvesting
Property	MedCAD® AccuPlan®Orthopedics System	CenterMed Patient MatchedAssisted Surgical Planning (ASP)System
	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.	bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
Preoperative software	Yes	Yes
Additivemanufacturing ofsurgical guides andmodels	Yes	Yes
Data inputs	Images from medical scanners	Images from medical scanners
Data outputs	Output for patient-specific surgicalguides and anatomical models	Output for patient-specific surgicalguides and anatomical models
Physical outputs	Patient-specific surgical guides,anatomical models, and patient-specific case reports	Patient-specific surgical guides,anatomical models, and patient-specific case reports
Materials	Biocompatible polymers andTi-6Al-4V ELI Titanium Alloy perASTM F136	Polyamide-12 (PA-12) with 316Lstainless steel sleeves when used ascutting guides
RecommendedTemporary ScrewDiameter	1.5mm – 2.1mm	1.5mm – 2.1mm
RecommendedTemporary ScrewLength	5mm – 22mm	5mm – 22mm
RecommendedTemporary ScrewStyle	Non-Locking	Drill-Free, Tapping-Free
Sterilization	Provided non-sterile and is steamsterilized by the end-user (SAL 10⁻⁶)	Provided non-sterile and is steamsterilized by the end-user (SAL 10⁻⁶)
ManufacturingMethod	Additive Manufacturing	Additive Manufacturing
Patient Contact	Implant – Tissue / Bone; Limited (<24 hours)	Implant – Tissue / Bone; Limited (<24 hours)
Patient Population	Adults and Pediatrics (12+)	Adults

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K223421

Comparison of Technological Characteristics with the Predicate Device

MedCAD® AccuPlan® Orthopedics System is substantially equivalent to its predicate device (K211614 CenterMed Patient Matched Assisted Surgical Planning (ASP) System).

Similarities to Predicate

The MedCAD® AccuPlan® Orthopedics System has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicate including software image transfer, manipulation, and surgical planning. The principles of operation and technological characteristics are either identical or substantially equivalent to the predicate. The system has similar technological characteristics including:

System inputs: Images from medical scanner systems (CT)
System outputs: Additively manufactured physical and/ or digital outputs such as patientspecific anatomical models and surgical guides for use in harvesting bone to support maxillofacial reconstructive surgeries
Software: Use of commercial off-the-shelf software to support the design phase of the device. ●
Sterility assurance level of 1x10-6 ●

The intended use of the subject device and the predicate both provide tools and accessories (software for image manipulation, anatomical models, and guides) for use in maxillofacial reconstructive surgery. Additionally, both the subject and the predicate device are intended to be used by trained personnel with active support from the surgeon.

Differences to Predicate

The only differences between the subject and predicate device relate to the addition of the 12+ pediatric population for the subject device and minor geometrical differences. A pediativ risk analysis was performed to support the change in patient population. Performance testing demonstrates that the minor material and geometrical differences do not raise new questions for safety and effectiveness.

Conclusion

The MedCAD® AccuPlan® Orthopedics System is substantially equivalent to its predicate device.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.