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.

Device Description

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.

AI/ML Overview

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:

Test	Acceptance Criteria	Reported Device Performance
Wear Debris Testing	The wear debris generated by the subject device must be less than what is reported in the literature to be safe.	PASS: The wear debris generated by the subject device is less than that reported in the literature to be safe.
Fit and Form Validation	All physical samples must meet predetermined alignment and fit acceptance criteria when optically scanned and fitted to a representative anatomical model.	PASS: All samples met the predetermined acceptance criteria (alignment with 3D model, and fit on anatomical model).

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.

Summary

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March 7, 2023

MedCAD % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K223024

Trade/Device Name: MedCAD® AccuPlan® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: February 6, 2023 Received: February 7, 2023

Dear Linda Braddon:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K223024

Device Name MedCAD® AccuPlan® System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K223024 510(k) Summary MedCAD® AccuPlan® System

March 7, 2023

Sponsor

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

Contacts

Secure BioMed Evaluations Linda Braddon, Ph.D. Justin Gracyalny, MSE 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® System Regulation Name: Bone Cutting Instruments and Accessories Regulation Number: 872.4120 Product Code: Primary - DZJ; Secondary - LLZ Classification Panel: Dental

Predicate Device(s)

MedCAD® AccuPlan® System (K192282)

Reference Device(s)

KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) MedCAD® AccuShape® Titanium Patient-Specific Cranial Plate (K220357)

Indication for Use:

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Device Description

System outputs include:

Anatomical Models ●
Surgical Guides
Dental Splints ●
Patient-Specific Case Reports .

Sterilization Validation

Sterlization 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.

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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.

Performance Testing

Performance testing for the MedCAD® AccuPlan® 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.	PASSThe wear debrisgenerated by the subjectdevice is less than thatreported in the literatureto be safe.
Fit and FormValidation	Subject devices from historical cases weremanufactured. The manufactured devices wereoptically scanned to verify alignment with the3D model. Evaluation of fit was also validatedby fitting the guide over the correspondingdefect in a representative anatomical model.	PASSAll samples met thepredeterminedacceptance criteria.

Substantial Equivalence

MedCAD® AccuPlan® System is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, and outputs. Minor differences in the surgical planning and manufacturing processes are verified and validated in the performance data in accordance with the intended use.

The input is images from medical scanners, dental models, and/or implants files. Physical outputs include dental splints and surgical guides. Biocompatible materials are used in the subject devices.

All devices are intended to aid in maxillofacial surgeries. These systems are intended to be utilized by trained employees with the approval by the physician.

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Med CAD

	COMPARISON OF TECHNOLOGICAL CHARACTERISITICS
	MedCAD® AccuPlan® System	MedCAD® AccuPlan® System
510(k) Number	K223024	K192282
Indications for Use	The MedCAD® AccuPlan® System isintended for use as a software systemand image segmentation system for thetransfer of imaging information from amedical scanner such as a CT basedsystem. The input data file is processedby the MedCAD® AccuPlan® Systemand the result is an output data file thatmay then be provided as digital modelsor used as input to a rapid prototypingportion of the system that producesphysical outputs including anatomicalmodels, surgical guides, and dentalsplints for use in maxillofacial surgery.The surgical guides and dental splintsare intended to be used for themaxillofacial bone in maxillofacialsurgery. The MedCAD® AccuPlan®System is also intended as a pre-operative software tool for simulating /evaluating surgical treatment options.	The MedCAD® AccuPlan® System isintended for use as a software systemand image segmentation system for thetransfer of imaging information from amedical scanner such as a CT basedsystem. The input data file is processedby the MedCAD® AccuPlan® Systemand the result is an output data file thatmay then be provided as digital modelsor used as input to a rapid prototypingportion of the system that producesphysical outputs including anatomicalmodels, surgical guides, and dentalsplints for use in maxillofacial surgery.The surgical guides and dental splintsare intended to be used for themaxillofacial bone in maxillofacialsurgery. The MedCAD® AccuPlan®System is also intended as a pre-operative software tool for simulating /evaluating surgical treatment options.
Preoperative software	Yes	Yes
Additive manufacturingof splints, guides, andmodels	Yes	Yes
Data inputs	Images from medical scanners	Images from medical scanners
Data outputs	Output for dental splints, surgicalguides, and anatomical models	Output for dental splints, surgicalguides, and anatomical models
Physical outputs	Dental splints, surgical guides,anatomical models, and patient-specificcase reports	Dental splints, surgical guides,anatomical models, and patient-specificcase reports
Materials	Biocompatible polymers and Ti-6Al-4VELI Titanium Alloy per ASTM F136	Biocompatible polymers
Sterilization	Provided non-sterile and is steamsterilized by the end-user	Provided non-sterile and is steamsterilized by the end-user
Manufacturing Method	Additive Manufacturing	Additive Manufacturing
Patient Contact	Surgical Guides: Implant - Tissue /Bone; Limited (< 24 hours)	Surgical Guides: Implant - Tissue /Bone; Limited (< 24 hours)
	Splint - Intermediate: SurfaceContacting - Mucosal Membrane;Limited (< 24 hours)	Splint - Intermediate: SurfaceContacting - Mucosal Membrane;Limited (< 24 hours)
	Splint — Final: ExternallyCommunicating - Tissue / Bone /Dentin: Limited (< 24 hours)	Splint — Final: ExternallyCommunicating - Tissue / Bone /Dentin: Limited (< 24 hours)

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Comparison of Technological Characteristics with the Predicate Device

MedCAD® AccuPlan® system is substantially equivalent to and it is safe and effective as its predicate device (MedCAD® AccuPlan® system - K192282).

Similarities to Predicate

The subject device is identical to that cleared in K192282 with the exception that the subject device also includes titanium cutting and drilling surgical guides. The anatomical models, splints, and positioning surgical guides are identical to those cleared in K192282.

The MedCAD® AccuPlan® System has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicates including software image transfer, manipulation, and surgical planning. The principals 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 scanners (ex: CT), dental models, and/or implant files (.STL)
System outputs: Physical and/ or Digital outputs such as patient-specific anatomical models, ● marking and positioning guides, and splints
Materials: Biocompatible polymers and Ti-6A1-4V ELI Titanium Alloy per ASTM F136 ●
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, splints, and guides) for use in 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 subject device is identical to that cleared in K192282 with the exception that the subject device also includes titanium cutting and drilling surgical guides. The inclusion of these components within the subject device system is similar to those cleared in the reference device (K181241). Safety and performance testing demonstrate that the addition of these components does not raise new questions for substantial equivalence.

Conclusion

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

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.