CenterMed Patient Matched Assisted Surgical Planning (ASP) 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 ASP 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, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Device Description

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a combination of software design and additive manufacturing for customized virtual pre-surgical treatment planning in maxillofacial reconstruction and orthognathic surgeries. The system processes patients' imaging data files obtained from the surgeons for treatment planning and outputs various patient-specific products (both physical and digital), including surgical guides, anatomical models, surgical splints, and surgical planning case reports. The physical products (surgical guides, anatomical models and surgical splints) are manufactured with biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).

AI/ML Overview

The CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner (e.g., CT) to produce digital models or physical outputs like anatomical models, surgical guides, surgical splints, and surgical planning case reports for maxillofacial surgery. It also serves as a pre-operative software tool for simulating/evaluating surgical treatment options.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical performance data (mechanical, biocompatibility, sterilization, software validation) as supportive evidence for substantial equivalence, rather than a direct clinical performance study with predefined acceptance criteria for sensitivity, specificity, etc. The acceptance criteria for these tests are largely based on meeting established ISO/ASTM standards or demonstrating compliance with pre-defined requirements.

Test Performed	Test Description/Guidelines	Acceptance Criteria	Reported Device Performance	Safety and Efficacy Confirmed
Mechanical Testing	ISO 178:2019, ISO 20795-2:2013	Maintain 85% of initial bending strength (for sterilized and aged test specimens).	Met the pre-defined acceptance criteria.	Yes
	ISO 20753:2018	Smaller test specimens for tensile testing designed according to standard.	Test specimens designed according to standard.	Yes
	ASTM D638	Larger test specimens for tensile testing designed according to standard.	Test specimens designed according to standard.	Yes
	ISO 527-2:2012	Maintain 85% of initial tensile strength (for sterilized and aged test specimens).	Met the pre-defined criteria.	Yes
Biocompatibility Testing
Cytotoxicity	ISO 10993-5, GB/T 16886.5-2017	No evidence of the test specimen causing cell lysis or toxicity.	Showed no evidence of cell lysis or toxicity.	Yes
Sensitization	ISO 10993-10, GB/T 16886.10-2017	No evidence of causing delayed dermal contact sensitization.	Showed no evidence of causing delayed dermal contact sensitization.	Yes
Intracutaneous Reactivity	ISO 10993-10, GB/T 16886.10-2017	No evidence of intra-cutaneous reactivity.	Showed no evidence of intra-cutaneous reactivity.	Yes
Acute Systemic Toxicity	ISO 10993-11, GB/T 16886.11-2011	No mortality or evidence of systemic toxicity.	Showed no mortality or evidence of systemic toxicity.	Yes
Pyrogenicity	USP <151>, ISO 10993-11	Met requirements for the absence of pyrogens.	Met the requirements for the absence of pyrogens.	Yes
Sterilization Validation	ANSI/AAMI/ISO 17665-1	Assurance of sterility of 10^-6^ SAL (sterility assurance level) for surgical guides, surgical splints and anatomical models.	Demonstrated assurance of sterility of 10^-6^ SAL.	Yes
Software Validation	Pre-defined requirement specifications	All software requirements and specifications implemented correctly and completely, traceable to system requirements; conformity with pre-defined specifications and acceptance criteria; mitigation of potential risks.	All COTS software applications are FDA cleared. Quality and on-site user acceptance testing confirmed correct and complete implementation of requirements, traceability, conformity with specifications, and risk mitigation.	Yes

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

The document does not describe a clinical study with a "test set" in the traditional sense of evaluating algorithm performance against ground truth on patient data. Instead, it details non-clinical tests for the physical and software components.

Mechanical Testing: Test specimens were used for bending and tensile testing. The specific number of specimens is not provided, but they were sterilized and aged to evaluate material properties.
Biocompatibility Testing: Test specimens (presumably of the device materials) were used for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity tests. The specific number of samples for each test is not detailed.
Sterilization Validation: Not specified, but sufficient samples would be used to demonstrate a sterility assurance level of 10^-6^.
Software Validation: This involved "Quality and on-site user acceptance testing" based on pre-defined requirement specifications. It does not refer to a data set for algorithm evaluation, but rather to the internal validation of the software development process and functionality.

The data provenance is from internal testing performed by the manufacturer or their designated testing facilities, rather than clinical patient data. The country of origin of the data is not specified directly, but the company is based in Walnut Creek, California, USA, and the tests refer to international standards (ISO, ASTM, USP). The studies were conducted specifically for the purpose of this 510(k) submission (prospective in the context of regulatory filing).

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

Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set of patient cases for performance evaluation. The "ground truth" for the non-clinical tests refers to the established scientific standards and criteria outlined by ISO, ASTM, and USP.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

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

No. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence, or safety and effectiveness of the CenterMed ASP System." Therefore, an MRMC comparative effectiveness study was not performed.

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

The device is described as a "software system and image segmentation system" and a "pre-operative software tool." While the software components are validated ("Software validation" section), this validation focuses on the correct implementation of specifications and mitigation of risks. It is not framed as a standalone performance study in the sense of an algorithm making decisions or predictions independently. The workflow involves trained engineers operating the software and physicians evaluating the outputs for surgical planning. The "standalone" performance being assessed here is the functional integrity and safety of the software and physical outputs according to design specifications, rather than a diagnostic performance metric.

7. The Type of Ground Truth Used

For the non-clinical studies described:

Mechanical Testing: Ground truth is derived from the established physical properties and limits defined by the ISO and ASTM standards.
Biocompatibility Testing: Ground truth is the biological safety criteria outlined in the ISO 10993 series and USP <151>.
Sterilization Validation: Ground truth is the defined sterility assurance level (SAL) of 10^-6^ as per ANSI/AAMI/ISO 17665-1.
Software Validation: Ground truth is the "pre-defined requirement specifications" for the COTS software components, ensuring they function as intended.

No pathology, expert consensus on patient images, or outcomes data were used as ground truth, as no clinical study directly evaluating algorithm performance on patient cases was conducted.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development of a machine learning algorithm that requires a "training set" of data. The software components mentioned are "Commercially off-the-shelf (COTS) software applications for image segmentation and processing." These are pre-existing software tools, not a newly developed AI algorithm that would undergo a training phase by CenterMed.

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

Not applicable, as there was no training set for a newly developed AI algorithm. The COTS software validation focused on their correct implementation and functionality within the CenterMed ASP System.

Summary

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June 28, 2021

CenterMed, Inc. % Jash Bhayani Director of Design 226 N Wiget Ln Walnut Creek, California 94598

Re: K201353

Trade/Device Name: CenterMed Patient Matched Assisted Surgical Planning (ASP) System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 25, 2021 Received: May 26, 2021

Dear Jash Bhayani:

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 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

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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 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 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) K201353

Device Name

CenterMed Patient Matched Assisted Surgical Planning (ASP) 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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K201353
Submitter Information
Submitter:	CenterMed, Inc.
Submitter Address:	226 N Wiget Ln,
	Walnut Creek, CA 94598
Contact Person:	Jash Bhayani
Contact Title:	Director of Design
Phone number:	855-840-8823
E-mail address:	Jash.Bhayani@centermed.com
Date Prepared:	May 25, 2021
	The content is prepared based on the requirements of 21CFR 807.92
Submission Information
Trade Name:	CenterMed Patient Matched Assisted Surgical Planning(ASP) System
Common Name:	System for the creation of patient specific anatomicalmodels, surgical splints, surgical guides and surgicalplanning case reports
Classification Name:	Bone Cutting Instruments and Accessories(21 CFR 872.4120);

Regulatory Class:	Class II
Product Code:	DZJ, LLZ
Predicate Device:	KLS Martin Individual Patient Solutions (IPS) PlanningSystem (K181241)
Device Description:	CenterMed Patient Matched Assisted Surgical Planning(ASP) System is a combination of software design andadditive manufacturing for customized virtual pre-surgicaltreatment planning in maxillofacial reconstruction andorthognathic surgeries. The system processes patients'imaging data files obtained from the surgeons for treatmentplanning and outputs various patient-specific products (bothphysical and digital), including surgical guides, anatomicalmodels, surgical splints, and surgical planning case reports.The physical products (surgical guides, anatomical modelsand surgical splints) are manufactured with

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biocompatible polyamide (PA-12) using additive manufacturing (Selective Laser Sintering).

Indications for Use: CenterMed Patient Matched Assisted Surgical Planning (ASP) 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 ASP 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, surgical guides, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

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1 Abbreviations
	Abbreviation	Definition
	ASP	Assisted Surgical Planning
	CBCT	Cone Beam Computed Tomography
	COTS	Commercially off-the-shelf
	CT	Computer Tomography
	DICOM	File Format; Digital Imaging and Communications in Medicine
	IPS	Individual Patient Solutions
	PA-12	Polyamide 12
	SAL	Sterility Assurance Level
	SLA	Stereolithography
	SLS	Selective Laser Sintering
	STL	File format used in 3D printing

2 General Workflow

The general workflow of CenterMed Patient Matched Surgical Planning System begins with software simulation of patients' imaging data files obtained from the surgeon for treatment planning. Products (surgical guides, surgical splints and anatomical models) are designed based on these imaging data files, converted to 3D STL files, and sent to manufacturing to be preprocessed, printed, and post-processed. Simultaneously, a surgical planning case report is created based on the same imaging data files as well as the STLs of the designed products. The completed output of the system includes the surgical planning case report, anatomical models, and corresponding surgical guides and/or surgical splints. These are packaged, labeled, and sent to the surgeon clean and non-sterile. The surgeon or relevant hospital staff will sterilize the surgical guides, surgical splints and anatomical models before use in the operating room. The workflow is shown in Figure 1.

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Image /page/6/Figure/2 description: This image is a flowchart that outlines the steps involved in a surgical treatment planning process. The process begins with input, which includes CT, CBCT, DICOM images, teeth models, and patient's digital photos. The next steps are design, pre-processing, printing, post-processing, and output, which leads to the end user sterilization.

Figure 1: General Workflow of CenterMed Patient Matched ASP System

3 Technological Characteristics / Substantial Equivalence Discussion

Both the subject device and predicate device have the same indications for use. The subject and predicate devices are 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 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, surgical splints and surgical planning case reports for use in maxillofacial surgery. The subject device and predicate device are also both intended as a pre-operative software tool for simulating/ evaluating surgical treatment options.

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4 Similarities to Predicate

Both the subject device and predicate device fit the same premarket regulation and are identical in conditions of use.

Both the subject device and predicate device share the same fundamental technologies. They both use a combination of software and hardware. Commercially off-the-shelf (COTS) software systems are used for image transfer, manipulation, surgical simulation as well as digital model creation of patient specific anatomical models, surgical splints and surgical guides. These software systems are intended to be operated by well-trained engineers and the outputs are evaluated by physicians. The additive manufacturing hardware is used to manufacture the physical models from the digital models.

Both the subject device and predicate device share fundamental technologies as follows:

Both use medical imaging data, such as CT scans, in DICOM format as input data file;
Both have the same system outputs, including anatomical models, surgical splints and . surgical guides;
Both generate digital models and surgical planning case reports to assist physicians in . how to use the products during clinical operation;
Both use the same materials for surgical guides (Polyamide-12); .
Both use additive manufacturing techniques for product manufacturing;
Both use the same manufacturing methods for printing surgical guides (Selective Laser Sintering (SLS));
. Both are passive medical devices;
Both are patient-specific devices;
Both are provided for single-use; ●
Both are provided non-sterile with an end-user sterilization method of steam sterilization . with the validated assurance level of 10to SAL;
. Both use temporary screws for surgical guide fixation to temporarily fix the surgical guide to the target bone surface for more precise guidance of the osteotomy/repositioning position;
Both devices require trained employees/engineers who utilize the software applications . to manage data and work with the physician to create the virtual surgical plan;
Both devices need the physician to provide input for surgical planning and interactive . feedback through viewing the digital models of system outputs that are modified by the trained employee/engineer during the planning session.

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5 Differences from Predicate

Subject device creates anatomical models using Polyamide-12 (PA-12) material with a . SLS manufacturing process, whereas the predicate device uses resin material with an SLA manufacturing process.
. Compared to that of the predicate device, the subject device's input data also includes patients' teeth models (either physical or digital models) and patients' digital photos.
For the predicate device, manufacturing materials include epoxy/resin and acrylic for . anatomical models, methacrylate for splints, and polyamide, Titanium Alloy (Ti-6A1-4V) and CP Titanium for guides. The subject device only uses PA-12 to manufacture all anatomical models, surgical guides, and surgical splints.
. The predicate device provides two kinds of surgical guides, one made with polyamide and the other made with Titanium Alloy (Ti-6Al-4V) and CP Titanium. The subject device only uses surgical guides made of polyamide, along with medical grade 316L stainless steel sleeves. Surgical splints of the subject device are made with the same manufacturing process as the surgical guides, both using polyamide as the raw material.
. The predicate device guides are used for bone cutting or marking, while those of the subject device are provided in three types: bone cutting, bone marking, and bone repositioning.
. The predicate device uses previously cleared fixation screws which range from 1.5mm -2.7mm diameter, with length of 4mm - 22mm. The subject device recommends a range of standard screw sizes to the doctor (diameter 1.5mm - 2.1mm, length 5mm - 22mm) (Standard screw sizes determined by manufacturer catalogs of medical grade screws for maxillofacial surgeries).
The predicate device utilizes four (4) commercially off-the-shelf (COTS) software . applications for image segmentation and processing, whereas the subject device utilizes three (3) commercially off-the-shelf (COTS) software applications for image segmentation and processing, and two (2) commercially off-the-shelf (COTS) software for manufacturing.
The predicate device has one contraindication that is not present in the subject device. . "Bone tumors located in the implant base region". The subject device does not include implants and therefore this contraindication is not relevant to the subject device. All other contraindications are identical to the predicate device.

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Table 1: Subject and Predicate Device Comparison

	Subject Device	Predicate Device
Characteristics	CenterMed Patient Matched AssistedSurgical Planning (ASP) System	KLS Martin IPS Planning System (K181241)
Product Code	DZJ, LLZ	DZJ, LLZ
Classification	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 872.4120, Class II21 CFR 892.2050, Class II
Common Name	System for the creation of patient specificanatomical models, surgical splints, surgicalguides and surgical planning case reports	System for the creation of patient specificanatomical models, cutting/marking guides,splints, and case reports
Indications foruse	CenterMed Patient Matched Assisted SurgicalPlanning (ASP) System is intended for use as asoftware system and image segmentation systemfor the transfer of imaging information from amedical scanner such as a CT based system. Theinput data file is processed by the ASP systemand the result is an output data file. This filemay then be provided as digital models or usedas input to a rapid prototyping portion of thesystem that produces physical outputs includinganatomical models, surgical guides, surgicalsplints and surgical planning case reports for usein maxillofacial surgery. CenterMed PatientMatched ASP System is also intended as a pre-operative software tool for simulating/evaluatingsurgical treatment options.	The KLS Martin Individual Patient Solutions(IPS) Planning System is intended for use as asoftware system and image segmentation systemfor the transfer of imaging information from amedical scanner such as a CT based system. Theinput data file is processed by the IPS PlanningSystem and the result is an output data file thatmay then be provided as digital models or used asinput to a rapid prototyping portion of the systemthat produces physical outputs includinganatomical models, guides, splints, and casereports for use in maxillofacial surgery. The IPSPlanning System is also intended as a pre-operative software tool for simulating/evaluatingsurgical treatment options.

Contraindications	1. Active infections (obvious, or clinicallyapparent).2. Hypersensitivity to foreign bodies.3. Circulatory problems, systematic diseases, ormetabolic disorders.4. Insufficient or inadequate bone tissue.5. Secondary diseases such as degenerativeprocesses that may have negative influences.6. Interventions carried out in a non-sterileenvironment7. Regions exposed to inappropriate forces orexcessive weight loads8. Patients unwilling to follow instructionsduring the postoperative phase due to theirmental, neurological, or physical condition.9. Obvious drug or alcohol abuse10. Significant changes to the patient's anatomyhave occurred since the medical scan used forplanning purposes was obtained.	1. Obvious infections.2. Hypersensitivity to foreign bodies.3. Circulatory problems, systemic diseases,and metabolic disorders.4. Insufficient or inadequate bone tissue.5. Secondary diseases such as degenerativeprocesses that may negatively influencethe healing process.6. Interventions carried out in a non-sterileenvironment (e.g. paranasal sinuses).7. Regions exposed to inappropriate forcesor excessive weight loads.8. Patients unwilling or unable to followinstructions during the postoperativephase due to their mental, neurological, orphysical condition.9. Bone tumors located in the implant baseregion.10. Obvious drug or alcohol abuse.11. Significant changes to the patient'sanatomy have occurred since the medicalscan used for planning purposes wasobtained.
ClinicalApplication	Maxillofacial surgeries	Maxillofacial surgeries
Prescription Use	Yes, intended to be used by physicians, not foruse by patients.	Yes, intended to be used by physicians, not for useby patients.
Energyused/delivered	Passive	Passive
10(k) Summary
System Inputs	CT, CBCT DICOM images,Teeth models (stone models, STL file or CBCTof mouth/teeth) if applicable, Patients' digitalphotos if applicable	CT, CBCT DICOM images
System Outputs	Anatomical models, Surgical splints, Surgicalguides, Surgical planning case reports	Anatomical models, Splints,Guides, Case reports
Materials	Anatomical models: Medical Grade Polyamide(PA-12)Surgical splints: Medical Grade Polyamide (PA-12)Surgical guides:3D Printed Part: Medical Grade Polyamide (PA-12)Sleeve: Medical Grade Stainless Steel 316L	Anatomical models: Epoxy/Resin, AcrylicSplints: MethacrylateCutting/Marking guides: Polyamide, TitaniumAlloy (Ti-6Al-4V), CP Titanium
ManufacturingMethod	Medical Grade Polyamide (PA-12):3D (Additive; Selective Laser Sintering (SLS))Medical Grade Stainless Steel 316L:Traditional (Subtractive)	Epoxy/Resin, Acrylic:3D (Additive; Stereolithography (SLA))CP Titanium: Traditional (Subtractive)Ti-6Al-4V: 3D (Additive; Selective LaserMelting)Polyamide: 3D (Additive; Selective LaserSintering)
Patient-specificconfiguration?	Yes	Yes
Provided forsingle use?	Yes	Yes
Provide sterile?	No	No
SterilizationMethod	Steam Sterilization	Steam Sterilization
10(k) Summary
RecommendedTemporary ScrewDiameter	1.5mm - 2.1mm	1.5mm - 2.7mm
RecommendedTemporary ScrewLength	5mm - 22 mm	4mm -22 mm
RecommendedTemporary ScrewStyle	Drill-Free, Tapping-Free	MaxDrive & CrossDrive(Drill-Free, locking [ThreadLock Taper Screw - TLTS])

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6 Device Types and Functions

Table 2 lays out the types, materials, and functions of the various devices offered in the CenterMed Patient Matched ASP System.

Category	Material	Function
Splint	• PA-12	• Maintaining occlusion
		• Positioning maxillofacial bone to intermediate or final occlusions
Marking Guide	• PA-12	• Marking of maxillofacial bone
	• 316L Stainless Steel
Cutting Guide	• PA-12	• Cutting/drilling maxillofacial bone
	• 316L Stainless Steel
Repositioning Guide	• PA-12	• Positioning maxillofacial bone
	• 316L Stainless Steel

Table 2: Types and Functions of CenterMed Patient Matched Devices

7 Non-clinical Performance Data

The following non-clinical performance testing was performed as supportive evidence to demonstrate substantial equivalence:

Mechanical testing
Biocompatibility testing .
Sterilization testing .
. Software validation

Table 3 shows an overview of the testing performed on surgical guides, surgical splints and validation testing performed on the COTS software.

			Table 3: Summarv of Non-Clinical Performance Data

Test performed	Testdescription/Guidelines	Conclusion	Safety and EfficacyConfirmed
Mechanical testing	ISO 178:2019, ISO20795-2:2013	The results showed that thesterilized and aged testspecimens met the pre-defined acceptance criteria:maintain 85% of initialbending strength. The testspecimens used for bending	Yes

		510(k) Summary
	ISO 20753:2018	The smaller test specimensused for tensile testing weredesigned according to thisISO standard.	Yes
	ASTM D638	The larger test specimensused for tensile testing weredesigned according to thisASTM standard.	Yes
	ISO 527-2:2012	The results showed that thesterilized and aged testspecimens can reach the pre-defined criteria: maintain 85%of initial tensile strength.	Yes
Cytotoxicity	ISO 10993-5, GB/T16886.5-2017	The results showed noevidence of the test specimencausing cell lysis or toxicity.	Yes
Sensitization	ISO 10993-10, GB/T16886.10-2017	The test specimen extractsshowed no evidence ofcausing delayed dermalcontact sensitization.	Yes
Intracutaneousreactivity	ISO 10993-10, GB/T16886.10-2017	The results showed noevidence of intra-cutaneousreactivity.	Yes
Acute Systemictoxicity	ISO 10993-11, GB/T16886.11 2011	The results showed nomortality or evidence ofsystemic toxicity.	Yes
Pyrogenicity	USP <151>, ISO10993-11	The results met therequirements for the absenceof pyrogens.	Yes
Sterilizationvalidation	ANSI/AAMI/ISO17665-1	The results demonstrated theassurance of sterility of 10-6SAL (sterility assurance level)for surgical guides, surgicalsplints and anatomical models	Yes
510(k) Summary
		individually packaged in asingle-pouched or wrappedsterilization configuration.
Software validation	Pre-defined requirement specifications	All the COTS software applications for image segmentation and manipulation are FDA cleared.Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to the system requirements. Testing required as a result of risk analysis (level of concern) and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and the system performs as intended based on the user requirements and specifications.	Yes

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Image /page/14/Picture/1 description: The image shows the logo for "Centermed". The logo is in a dark red color. There is a line above the letters "ent" in the logo. There is a registered trademark symbol to the right of the logo.

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Image /page/15/Picture/1 description: The image shows the word "Centermed" in a stylized, maroon-colored font. A horizontal line extends above the word, and a circled "R" symbol is present to the right of the word, indicating a registered trademark. The font is bold and slightly italicized, giving the word a dynamic and modern appearance.

8 Clinical Performance Data

Clinical testing was not necessary for the determination of substantial equivalence, or safety and effectiveness of the CenterMed ASP System. The predicate device did not perform clinical testing for their products (surgical guides, splints, anatomical models, case reports), and since there are no significant technological differences, or significant indications for use differences between the subject device products (surgical guides, surgical splints, anatomical models, surgical planning case reports) and the predicate device, clinical testing is not needed for the subject device.

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Image /page/16/Picture/1 description: The image shows the logo for Centermed. The logo is in a dark red color and features a stylized font. A horizontal line runs above the text. A registered trademark symbol is located in the upper right corner of the logo.

9 Animal Studies Data

Animal testing was not necessary for the determination of substantial equivalence, or safety and effectiveness of the CenterMed ASP System. The predicate device did not perform animal testing for their products (surgical guides, splints, anatomical models, case reports), and since there are no significant technological differences, or significant indications for use differences between the subject device products (surgical guides, surgical splints, anatomical models, surgical planning case reports) and the predicate device, animal testing is not needed for the subject device.

10 Conclusions

The predicate device chosen was KLS Martin Individual Patient Solutions System. It was shown that the subject device, CenterMed Assisted Surgical Planning System is substantially equivalent to the predicate device. Both have the same indications for use as a software and image segmentation system for the transfer of imaging information from a medical scanner, and both result in creation of outputs such as anatomical models, surgical guides, surgical splints and surgical planning case reports for use in maxillofacial surgery. Both create physical outputs using rapid prototyping. They are both intended for use as a pre-operative software tool for simulating and evaluating surgical treatment options.

Any differences between the predicate device and the subject device have been thoroughly analyzed to conclude no safety or efficacy issues in the subject device. A full risk analysis was performed to determine the safety of the device, and any residual risk has been justified. Additionally, mechanical, biocompatibility, and sterilization tests have been performed. All tests passed their respective test criteria. Software risk analysis and validation was also performed of the COTS software used to design and manufacture the subject device.

Based on the comparisons and analyses detailed above in this summary, we believe that the information and performance test reports of the subject device provided in this 510(k) submission are sufficient to demonstrate and provided support the conclusion of Substantial Equivalence to the 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.