The OsteoPlan™ 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 OsteoPlan™ System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Device Description

OsteoMed uses computer aided modeling to assist the physician with planning complex maxillofacial surgeries. Specifically, the OsteoPlan™ System provides patient-specific anatomical models, splints, and patient-specific surgical plans and digital files of the surgical plan to assist physicians with maxillofacial surgeries. Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution. All outputs are manufactured by OsteoMed using additive manufacturing (SLS and SLA), only with direct physician involvement to reduce the criticality of the outputs.

The system uses electronic medical images of the patient anatomy (CT and CBCT) with input from the physician to create the plan and splints for executing surgery. Off-the-shelf (OTS) software is used for surgical planning.

The outputs of the system include Orthognathic Occlusal Splints, Case Reports, and Anatomic models. The splints are offered in commonly used forms, in both intermediate and final positioning, and some are available with ligature holes.

Case reports are digital and physical documents created to lay out the surgical plan, dictated by the surgeon, and show outputs of the OsteoPlan™ system that will be used to translate the plan during surgery.

Anatomic models are tools provided to physicians for complex anatomy visualization or to preplan surgery with an accurate physical representation of patient anatomy. Anatomic models may include maxilla, mandible, or skull models.

AI/ML Overview

This Premarket Notification (510(k)) summary for the OsteoPlan System does not include specific details on acceptance criteria and device performance in the format requested. The document focuses on establishing substantial equivalence to predicate devices through a comparison of technological characteristics and a summary of non-clinical testing.

Here's what can be extracted and what information is not present based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text in a quantifiable table format for the OsteoPlan System's primary functions (e.g., accuracy of segmentation, precision of surgical planning). The document generally states that "All testing passed" or "all acceptance criteria being met" for various validations, but doesn't detail what those criteria were nor the specific performance metrics achieved.

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

This information is not explicitly provided for the software's core functionality (image segmentation, surgical planning).

For the "Cadaver Study," a "simulated use" study was conducted, indicating a test set was used, but its size and specific provenance (e.g., number of cadavers, country of origin) are not mentioned. The study is prospective in nature as it verified the functionality of the design.

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

This information is not provided. The document states that "Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution," implying expert involvement in the design and review process, but it doesn't specify how many experts or their qualifications for establishing ground truth in a formal validation test set.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not mentioned. There is no indication of a comparative effectiveness study comparing human readers with and without AI assistance.

6. Standalone Performance

The document mentions "Software Validation and documentation for software of moderate level of concern was provided per the FDA Guidance Document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Off-The-Shelf Software Use in Medical Devices.' All software verification/validation passed." This indicates that standalone testing of the software was performed, but the specific standalone performance metrics (e.g., accuracy, precision) are not detailed. It states "The OsteoPlan™ System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner... The input data file is processed by the OsteoPlan™ System and the result is an output data file," implying standalone operation.

7. Type of Ground Truth Used

For the software's core functions (segmentation, planning), the specific type of ground truth (e.g., expert consensus on anatomies, pathology reports) used for validation is not explicitly stated. Given the pre-operative planning nature, it would likely involve expert consensus or established anatomical landmarks.

8. Sample Size for the Training Set

This information is not provided. The document doesn't mention a training set, which is typical for AI/ML models. However, the OsteoPlan System is described as using "Off-the-shelf (OTS) software used for surgical planning," suggesting it might be an adaptation or integration of existing tools rather than a completely novel AI model requiring extensive de novo training data for its core algorithms.

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

This information is not provided, as no training set is mentioned.

Summary of available information regarding acceptance criteria and performance:

The document broadly states that various non-clinical tests were conducted and "all acceptance criteria being met" or "All testing passed." These tests cover:

Equipment/Process Qualification (IQ/OQ/PQ)
Software Validation (for moderate level of concern)
Cleaning Validations
Steam Sterilization Validation
Biocompatibility testing (cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, subchronic toxicity, implantation) for worst-case splint and anatomical model
Packaging Validation
Shelf Life (functional testing)
Cadaver Study (simulated use to verify design functionality)

Crucially, the document does not provide the specific quantifiable acceptance criteria or the numerical results of performance tests for the software's primary functions of image segmentation or surgical planning accuracy. Instead, it relies on a general statement of "all testing passed" and "performance equivalence was shown through the verification comparison to the predicate device" to establish substantial equivalence.

Summary

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February 11, 2022

OsteoMed Diane Rutherford Regulatory Affairs Manager 3885 Arapaho Road Addison, Texas 75001

Re: K212570

Trade/Device Name: OsteoPlan System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: November 12, 2021 Received: November 15, 2021

Dear Diane Rutherford:

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,

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) K212570

Device Name OsteoPlan 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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510(k) SUMMARY K212570

I. SUBMITTER

OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA Phone: 972-677-4795 Fax: 972-677-4601 Email: diane.rutherford(@acumed.net Contact Person: Diane Rutherford Date Prepared: February 9, 2022

II. DEVICE

Name of the Device:	OsteoPlan™ System
Common or Usual Name:	Patient specific maxillofacial anatomical models, splints, and surgical plans
Classification Name:	Bone Cutting Instrument and Accessories
Classification:	Class II, 21 CFR 872.4120
Product Code:	DZJ, LLZ

III. PREDICATE DEVICES

Predicate Device: VSP® System, Medical Modeling, Inc (K133907, K120956)

Reference Device: Surgicase Guides, Materialise (K103136)

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

The OsteoPlan™ 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 OsteoPlan System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The principles of operation and technological characteristics are substantially equivalent between the subject device and the primary predicate, VSP System. Specifically, the predicate device includes patient specific anatomic models and splints produced through 3D printing. The only difference in the Technological Characteristics is found in the materials of the outputs. The OsteoPlan System uses photopolymers for splints while the VSP System uses photopolymers (with stainless-steel inserts) in the cutting guides of the system. The OsteoPlan System uses Polyamide anatomic models (Polyamide 12) produced through an SLS printing process equivalent to the reference device. SurgiCase Guides (K103136), which includes outputs for the same anatomic region, made out of identical material (Polyamide 12) and printing process (SLS). The subject device contains a subset of the outputs of the predicate and reference device.

	New Device	Primary Predicate	Reference Predicate
Trade Name	OsteoMed OsteoPlan™System K212570	Medical Modeling VSPSystem K133907, K120956	Materialise SurgicaseGuides K103136
Indication for Use	The OsteoPlan™ 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 theOsteoPlan System and the result isan output data file that may then beprovided as digital models or usedas input to the additivemanufacturing portion of the systemthat produces physical outputsincluding anatomical models andsplints for use in maxillofacialsurgery. The OsteoPlan System isalso intended as a pre-operativesoftware tool for simulating /evaluating surgical treatmentoptions.	The Medical Modeling VSPSystem 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 VSPSystem and the result is an outputdata file that may then beprovided as digital models or usedas input to a rapid prototypingportion of the system thatproduces physical outputsincluding anatomical models,templates, and surgical guides foruse in maxillofacial surgery. TheVSP System is also intended as apre-operative software tool forsimulating / evaluating surgicaltreatment options.	SurgiCase Guides areintended to be used assurgical tools to transfer apre-operative plan tothe surgery. The devices areintended to guide themarking of bone and/orguide surgicalinstruments in mandibularand maxillofacial surgicalprocedures.SurgiCase Guides areintended for single use only.
Outputs	Anatomic ModelsSurgical Positioning Templates(splints)Patient Specific Case Reports	Anatomical ModelsSurgical PositioningTemplates/GuidesOsteotomy Templates/GuidesPatient Specific Case ReportsPlate Bending Templates/GuidesStainless Steel Culling and DrillInserts	Surgical PositioningTemplates/GuidesOsteotomy Templates/GuidesPatient Specific Case ReportsPlate BendingTemplates/Guides

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OsteoMed OsteoPlan™ System Traditional 510(k)

	New Device	Primary Predicate	Reference Predicate
Trade Name	OsteoMed OsteoPlanTMSystem K212570	Medical Modeling VSPSystem K133907, K120956	Materialise SurgicaseGuides K103136
AdditiveManufacturing	Yes	Yes	Yes
BiocompatibleMaterials	Yes	Yes	Yes
Patient-ContactingExternalCommunicatingTissue/Bone/Dentin	Limited (<24 hours):ModelsProlonged (24 hours -30 Days):Splints	Limited and Prolonged	Limited

VII. SUMMARY OF NON-CLINICAL TESTING

The following performance data were provided in support of the substantial equivalence determination.

Equipment/Process Qualification (IQ/OQ/PQ) was performed in accordance with the OsteoMed quality management system with all validations meeting acceptance criteria.
Software Validation and documentation for software of moderate level of concern was provided per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Off-The-Shelf Software Use in Medical Devices." All software verification/validation passed.
Cleaning Validations were performed in accordance with FDA Guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. All testing passed.
Steam Sterilization Validation was conducted using both pouches and rigid sterilization containers in accordance with ANSI/AAMI/ISO 17665-1 "Sterilization of health care products-Moist heat-Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
Biocompatibility testing for the worst-case splint and anatomical model was conducted per its contact classification according to the 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" Testing included: cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, subchronic toxicity, and implantation. All biocompatibility testing passed.
Packaging Validation was conducted to confirm that the packaging for the OsteoPlan System protects and retains the splints and models during normal shipping and handling. All testing passed.
Shelf Life was established with functional testing to confirm the specified requirements were met. All testing passed.
A Cadaver Study was conducted to verify the functionality of the design of the OsteoPlan system via simulated use with all acceptance criteria being met.

Performance equivalence was shown through the verification comparison to the predicate device.

Clinical testing is not required to support substantial equivalence.

CONCLUSION VIII.

The conclusions drawn from the nonclinical tests demonstrate that the OsteoMed OsteoPlan™ System is substantially equivalent to the legally marketed device predicates.

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.