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 including anatomical models, surgical guides, and dental splints for use in maxillofacial 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 preoperative 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, surgical quides, dental splints, and patient-specific case reports.

AI/ML Overview

This document (K192282) is a 510(k) premarket notification for the MedCAD® AccuPlan® System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (VSP® System, Medical Modeling, Inc. K120956).

The document does NOT contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the types of quantitative performance metrics typically associated with AI/ML device approval (e.g., sensitivity, specificity, AUC). This is likely because the MedCAD® AccuPlan® System, as described, is primarily a software system for image processing and generating physical models/guides, rather than an AI/ML diagnostic or prognostic tool that would require such performance evaluations. The performance data section focuses on manufacturing process validation, dimensional analysis, mechanical performance, and software system validation for basic functionality, rather than clinical performance metrics based on a test set.

Therefore, many of the requested details related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics cannot be extracted from this document. The document focuses on demonstrating that the device meets design inputs and is substantially equivalent to a predicate device in its intended function and manufacturing quality.

Below, I will extract relevant information that is present in the document, acknowledging where the requested information is absent or not applicable based on the nature of this device's submission.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity for disease detection) and corresponding reported device performance metrics in the way an AI/ML diagnostic device would.

Instead, the "Performance Data" section describes categories of validation performed:

Acceptance Criteria (Implied / Type of Validation)	Reported Device Performance (Summary)
Device Performance Validation	"Successfully demonstrates that design outputs meet design inputs."
Process Validation (IQ, OQ, PQ)	"Ensure that the manufacturing process can effectively produce patient-matched devices." "Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing... meet production needs."
Dimensional Analysis	"Performed to ensure the proper fit of the final output." (No specific metric provided, just that it was done and presumably passed).
Mechanical Performance	"Assessing dynamic compressive strength and ligature wire pullout testing were conducted on final, finished devices demonstrating they are equivalent to the predicate device." (Implies meeting equivalence thresholds, but no specific values are given.)
Software System Validation	"Off-the-shelf software packages are operating correctly and any necessary file conversions will not negatively impact the final output."
Independent Subsystem Verification	"Verification of each independent software subsystem against defined requirements"
Subsystem Compatibility Verification	"Verification of compatibility between software subsystems against defined requirements"
Integrated System Validation	"Validation of fully integrated system including all subsystems against overall system requirements"
Sterilization Validation	"Conducted in accordance with international standard ISO 17665 and FDA guidance document... to a Sterility Assurance Level (SAL) of 1x10-9. All test method acceptance criteria were met."
Biocompatibility Validation	"Conducted in accordance with international standard ISO 10993-1 and FDA guidance document... The results of the testing adequately address biocompatibility for the output devices and their intended use." (No specific metrics, but attests to meeting standard requirements).

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes validation efforts in terms of process, software, and material properties, rather than an evaluation of clinical performance on a "test set" of patient data for diagnostic accuracy. The input data comes from "medical scanners such as a CT based system." There is no mention of the origin or type of patient data used for any performance validation beyond its source (medical scanners).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/provided in the document. The device is a "software system and image segmentation system" for planning and producing physical outputs. It's not a diagnostic AI/ML tool requiring expert-established ground truth for disease detection for a test set. The process involves "clinical input and review from the physician" for planning, but this is part of the operational workflow rather than establishing a "ground truth" for an algorithm's performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided in the document, for the same reasons as #3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided in the document. An MRMC study is typically performed for AI/ML diagnostic aids that assist human readers. The MedCAD® AccuPlan® System's stated function does not involve assisting human readers in interpreting images for diagnosis. It's a tool for planning and manufacturing.

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

This information is not applicable/provided as a formal standalone performance study with clinical endpoints. The software aspects are validated for correctness and compatibility of data processing and file conversions, as noted in the "Software System Validation" section. However, this is related to its functional accuracy as a tool, not its diagnostic accuracy in a clinical context. The device is described as being "operated only by trained MedCAD employees" and requiring "clinical input and review from the physician during planning." This implies it's always used with human oversight.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/provided in the context of traditional "ground truth" for diagnostic AI. For the dimensional analysis of the physical outputs (anatomical models, surgical guides, dental splints), the "ground truth" would be the intended dimensions/specifications derived from the original medical images and planning. The "proper fit of the final output" is assessed against these design inputs.

8. The sample size for the training set

This information is not provided in the document. The MedCAD® AccuPlan® System is described as using "Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical scan images." There is no indication of a machine learning (ML) model being "trained" in the conventional sense, as is common with many AI devices. The validation focuses on the correct functioning and integration of these COTS software components and the manufacturing process.

9. How the ground truth for the training set was established

This information is not applicable/provided since there is no mention of a training set or an ML model being trained for this device as it is characterized in the 510(k) submission.

Summary

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October 29, 2020

MedCAD % Linda Braddon, Ph.D. President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K192282

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: October 2, 2020 Received: October 2, 2020

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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192282 Device Name

MedCAD® AccuPlan® System

Indications for Use (Describe)

Type of Use (Select one or bothas applicable)

図 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (301) 443-6740
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Image /page/3/Picture/0 description: The image shows the logo for MedCAD. The text "Med" is in a large, bold, serif font. The text "CAD" is in a smaller, sans-serif font and is set against a blue-green background. The background is a parallelogram shape.

510(k) Summary MedCAD® AccuPlan® Svstem K192282

October 29, 2020

Sponsor

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

Contact

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

Name of Device and Classification Name

Device Name: MedCAD® AccuPlan® System Regulation Name: Bone Cutting Instruments and Accessories Requlation Number: 872.4120 Product Code: Primary - DZJ; Secondary - LLZ Classification Panel: Dental

Predicate Device

VSP® System, Medical Modeling, Inc. (K120956)

Indication for Use:

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

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Med C

original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, surgical quides, dental splints, 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 of the patient's teeth) to create patientspecific 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 thev 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 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 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 ●

Performance Data

The performance data indicates that the verification and validation testing performed on the MedCAD® AccuPlan® system successfully demonstrates that design outputs meet design inputs.

Device Performance Validation

The performance testing for the device includes processes validation methods such as IQ, OQ. and PQ to ensure that the manufacturing process can effectively produce patient matched devices. Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, dental splints, and anatomical models meet production needs. Dental splints and surgical quides are manufactured based on

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recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."

Additionally, a dimensional analysis was performed to ensure the proper fit of the final output. Mechanical performance evaluations assessing dynamic compressive strength and ligature wire pullout testing were conducted on final, finished devices demonstrating they are equivalent to the predicate device.

Software System Validation

In order to ensure the off-the-shelf software packages are operating correctly and any necessary file conversions will not neqatively impact the final output, software verification and validation activities include:

· Verification of each independent software subsystem against defined requirements
Verification of compatibility between software subsystems aqainst defined . requirements
Validation of fully integrated system including all subsystems against overall . system requirements

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 1x10-9. All test method acceptance criteria were met.

Biocompatibility Validation

Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 and FDA quidance 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.

Substantial Equivalence

MedCAD® AccuPlan® system is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, 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 creation of 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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Image /page/6/Picture/0 description: The image shows the logo for MedCAD. The text "Med" is in a large, bold, black font. The text "CAD" is in a white, bold font and is set against a teal background. There is a registered trademark symbol in the upper right corner of the teal background.

COMPARISON OF TECHNOLOGICAL CHARACTERISITICS
	MedCAD® AccuPlan® System	VSP® System MedicalModeling Inc.
510(k) number	K182282	K120956
Indications for Use	The MedCAD® AccuPlan® System isintended for use as a softwaresystem and image segmentationsystem for the transfer of imaginginformation from a medical scannersuch as a CT based system. Theinput data file is processed by theMedCAD® AccuPlan® System andthe result is an output data file thatmay then be provided as digitalmodels or used as input to a rapidprototyping portion of the system thatproduces physical outputs includinganatomical models, surgical guides,and dental splints for use inmaxillofacial surgery. The surgicalguides and dental splints areintended 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 treatmentoptions.	The Medical Modeling VSP®System is intended for use as asoftware system and imagesegmentation system for thetransfer of imaging informationfrom a medical scanner such as aCT based system. The input datafile is processed by the VSP®System and the result is an outputdata file that may then be providedas digital models or used as inputto a rapid prototyping portion of thesystem that produces physicaloutputs including anatomicalmodels, templates, and surgicalguides for use in maxillofacialsurgery. The VSP® System is alsointended as a pre-operativesoftware tool for simulating /evaluating surgical treatmentoptions.
Preoperative software	Yes	Yes
Additive manufacturing ofsplints, guides, and models	Yes	Yes
Data inputs	Images from medical scanners	Images from medical scanners
Data outputs	Output for dental splints, surgicalguides, and anatomical models	Output for anatomical models,templates, and surgical guides
Physical outputs	Dental splints, surgical guide,anatomical models, and patient-specificcase reports	Templates, surgical guides, andanatomical models
Materials	Biocompatible polymers	Biocompatible polymers
Sterilization	Subject device is provided non-sterileand is steam sterilized by the end-user	Predicate device is provided non-sterile and is steam sterilized bythe end-user
Manufacturing Method	Additive Manufacturing	Additive Manufacturing
Patient Contact	Guides: Surface Contacting - Tissue/ Bone / Mucosal Membrane Limited(< 24 hours)Splints: Surface Contacting -Mucosal Membrane Limited (< 24hours)	Limited (< 24 hours)Prolonged (< 30 days)Surface Contacting - Mucosal

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 (VSP® System, Medical Modeling, Inc. – K120956).

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Image /page/7/Picture/0 description: The image shows the logo for MedCAD. The word "Med" is in a large, bold, black serif font. The word "CAD" is in a smaller, white sans-serif font inside of a teal box. There is a small registered trademark symbol to the right of the teal box.

Similarities to Predicate

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, guides, and splints
Materials: Biocompatible polymers
. 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 quides) 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 following differences exist between the subject and predicate device:

The predicate specifically refers to support of reconstructive surgery. The subject ● device will support both orthognathic (correction of jaw conditions) and reconstructive surgeries.
. The predicate device contains a set of stainless-steel cutting and drill inserts which are intended to be used by the physician to quide cutting and drilling activities during the surgical procedure. The subject device is intended to be used only for positioning and marking as determined by the physician. There is no use of stainless-steel cutting and drill inserts with the subject device.
. The predicate system includes the use of surgical guides for graft bone harvesting which can include the fibula and hip. The subject device is not intended to be used for bone harvesting and is to be used only in the maxillofacial region of the body.
. The Indications for Use statements differ slightly in that the predicate device lists the physical outputs to include "anatomical models, templates, and surgical quides" whereas the subject device includes "anatomical models, surgical quides, and dental splints". Additionally, the subject device contains the statement "The surgical guides and dental splints are intended to be used for the maxillofacial bone in maxillofacial surgery."

Conclusion

MedCAD® AccuPlan® is substantially equivalent to and is as safe and effective as its predicate device. Both devices incorporate similar inputs, operations, and outputs.

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.