The KLS Martin Individual Patient Solutions (IPS) Planning 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 IPS Planning 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, guides, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Device Description

The KLS Martin Individual Patient Solutions (IPS) Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive and orthognathic surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, guides, splints and case reports.

AI/ML Overview

The provided text describes the KLS Martin Individual Patient Solutions (IPS) Planning System and its regulatory clearance (K182789) by the FDA. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/algorithm's performance.

Instead, the document is a 510(k) summary demonstrating substantial equivalence to a predicate device (K181241), primarily to expand the patient population to include pediatric subgroups. The core of the device is a planning system involving commercial off-the-shelf (COTS) software and additive manufacturing for physical outputs, with human-in-the-loop interaction from trained employees/engineers and physicians.

Therefore, most of the requested information regarding AI acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in the provided document. The device, as described, is not an AI algorithm in the sense that it performs automated diagnostic or treatment recommendations independently based on image analysis with defined metrics. It's a system to assist human planning processes.

Here's an analysis based on the information available in the document, and a clear indication of what is not available.

Acceptance Criteria and Device Performance (as far as applicable from the document)

The document focuses on demonstrating substantial equivalence, not on acceptance criteria for a freestanding AI algorithm's performance. The "performance" described is primarily related to material properties, biocompatibility, and sterilization, and the functioning of the software as a tool for human planning.

Acceptance Criteria (Inferred from Substantial Equivalence and Safety/Performance)	Reported Device Performance (from document)
Material Degradation (Polyamide Guides)	Subject polyamide guides can withstand multiple sterilization cycles without degradation and can maintain 85% of its initial tensile strength. Demonstrates shelf life of 6 months. (p.10)
Titanium Device Equivalency	Additively manufactured titanium devices are equivalent to, or better than, titanium devices manufactured using traditional (subtractive) methods, leveraging data from reference device K163579. (p.10)
Biocompatibility	Biocompatibility endpoints (cytotoxicity, sensitization, irritation, chemical/material characterization) for both polyamide and titanium manufactured devices met pre-defined acceptance criteria (leveraged from predicate K181241 and reference K163579). (p.10)
Sterility Assurance Level (SAL)	Achieved an SAL of 10^-6 for each output device using the biological indicator (BI) overkill method for steam sterilization. Validations for polyamide and titanium leveraged from predicate K181241 and reference K163579. (p.10)
Pyrogenicity (Endotoxin Levels)	Endotoxin levels were below the USP allowed limit for medical devices and met pyrogen limit specifications, leveraging data from reference device K163579 for titanium. (p.10)
Software Functionality and Validation	Quality and on-site user acceptance testing provided objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements. Testing from risk analysis showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates mitigation of potential risks and performance as intended. (p.11, p.14)
Safety and Effectiveness in Pediatric Subpopulations	A risk assessment based on FDA guidance and supporting peer-reviewed clinical literature was performed. The conclusion is that expanding the patient population to neonates, infants, and children does not identify new issues of safety or effectiveness and the device is substantially equivalent to the predicate. (p.5, p.11, p.14) Note: This is a risk assessment and literature review, not a new clinical performance study.

Information NOT Available in the Document (as it pertains to an AI/Algorithm performance study):

Sample size used for the test set and data provenance:
This information is not provided. The study performed was primarily non-clinical (material testing, biocompatibility, sterilization) and a risk assessment for pediatric use, not a clinical trial evaluating algorithm performance on a test set of patient data.
Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable, as no dedicated test set for evaluating AI/algorithm performance against a ground truth is described. The system relies on physician input and interaction with trained employees/engineers for planning, not on an autonomous algorithmic output that requires expert adjudication for ground truth.
Adjudication method for the test set:
Not applicable for the same reasons as above.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." (p.11, p.14). The device is a planning system with human-in-the-loop, not an AI intended to improve human readers' performance directly.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not described. The device is presented as a "software system and image segmentation system" where "trained employees/engineers... manipulate data and work with the physician to create the virtual planning session." (p.4, p.13) The core function described is human-assisted planning and production of physical models, not an autonomous algorithmic output.
The type of ground truth used:
Ground truth in the context of an AI algorithm's diagnostic or predictive performance is not relevant here, as no such AI is described. The "ground truth" for the device's function would relate to the accuracy of the generated physical models and plans relative to the patient's anatomy and surgical intent, which is managed through human interaction and validation within the system's intended use.
The sample size for the training set:
Not applicable. The document refers to "commercially off-the-shelf (COTS) software applications" (p.4, p.13) which implies existing, validated software tools are being used, not a newly developed AI model requiring a separate training set.
How the ground truth for the training set was established:
Not applicable, as no new training set for an AI model is described.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

KLS-Martin L.P. Pam Martin Regulatory Affairs Supervisor 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246

March 11, 2019

Re: K182789

Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: February 4, 2019 Received: February 8, 2019

Dear Pam Martin:

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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner - S3

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182789

Device Name

KLS Martin Individual Patient Solutions (IPS) Planning System

Indications for Use (Describe)

The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scamer such as a CT based system. The input data file is processed by the IPS Planning 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, guides, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

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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Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are larger than the other letters in the logo.

11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com

	510(k) Summary21 CFR 807.92	K182789
Submitter:	KLS-Martin L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Pam Martin, RAC, MScRegulatory Affairs SupervisorPhone: 800-625-1557Email: pmartin@klsmartin.com
Date Prepared:	February 4, 2019
Trade Name:	KLS Martin Individual Patient Solutions (IPS) PlanningSystem
Common Name:	System for the creation of patient specific anatomicalmodels, cutting/marking guides, splints, and case reports
Classification Name:	Bone Cutting Instruments and Accessories (21 CFR872.4120); System, Image Processing, Radiological (21 CFR892.2050
Regulatory Class:	II
Product Code:	DZJ, LLZ
Predicate Device:	KLS Martin Individual Patient Solutions (IPS) PlanningSystem (K181241) - Primary
Reference Devices:	KLS Martin Individual Patient Solutions (K163579)KLS Mini Osteosynthesis System (K943347)KLS Martin Centre-Drive Drill-Free Screws (K971297)

Device Description:

Indications for Use:

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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black and are smaller than the other letters/words in the logo.

Technological Characteristics/Substantial Equivalence Discussion:

The indications for use are identical for both the subject and predicate device. Further, the intended use of the subject device, KLS Martin Individual Patient Solutions (IPS) Planning System, is identical to the predicate device, the KLS Martin Individual (IPS) Patient Solutions System (K181241):

The subject and primary 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 through the virtual planning software systems 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. These physical outputs can be anatomical models, guides, splints, templates, and case reports. All digital data and physical devices are used to aid the surgeon during maxillofacial surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Similarities to Predicate

The KLS Martin Individual Patient Solutions (IPS) Planning System, K181241, is identical to the subject device's technological characteristics with regard to software, material composition, biocompatibility, manufacturing process, performance testing, as well as cleaning and sterilization.

Both the subject and primary predicate devices use image data obtained from medical scanners, such as a CT scan. The subject device utilizes four (4) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation identical to what was evaluated in the predicate device, K181241. The validated commercially off-the-shelf (COTS) software applications to transfer patient imaging from a DICOM format to a .STL format and manipulate the images to produce a final design file. In addition, both devices require trained employees/engineers who utilize the software applications to manipulate data and work with the physician to create the virtual planning session. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the trained employee/engineer during the planning session.

Both systems use additive manufacturing methods to produce physical output devices that include patient specific anatomical models, guides, and splints. In addition, the systems produce digital models and case reports for the physician to use for planning of maxillofacial surgeries or to use during surgery.

Materials used in the manufacture of the subject output devices are synthetic polymers, acrylic resins, and titanium (CP titanium & Titanium Alloy) identical to what was evaluated in the predicate device, K181241. All output devices from both systems are provided non-sterile and must be sterilized by the end user prior to use. Validated sterilization studies were performed to ensure a sterility assurance level (SAL) of 10-9.

In addition, the subject device uses previously cleared fixation screws that are utilized for temporary guide fixation during cutting and marking of the bone. The screws range from 1.5 mm - 2.7 mm with lengths of 4 mm - 22 mm identical to what was evaluated in the predicate device, K181241.

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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are larger than the other letters in the logo. The logo is simple and modern.

Differences to Predicate

The predicate device, K181241, was cleared for the adolescent (12 to 21 years of age) and adult populations.

The purpose of this submission is to expand the patient population to include the following pediatric subpopulations:

. Neonates (birth to 28 days)
Infants (29 days to < 2 years of age ●
Children (2 years of age to < 12 years of age) ●

A risk assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for these subpopulations with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use in the pediatric subpopulations.

Reference Devices

KLS Martin Individual Patient Solutions (K163579) has been included as a reference device to leverage performance testing with regard to material composition (material recycling process / degradation / tensile / bending), biocompatibility, manufacturing process, performance testing, as well as cleaning and sterilization for titanium guides. The KLS Martin IPS Planning System titanium guides are manufactured from identical materials (CP Titanium & Titanium Alloy), undergo the same manufacturing processes, have the same biocompatibility, demonstrate similar performance characteristics, and are cleaned and sterilized using the same validated methods as the titanium implants in the KLS Martin Individual Patients Solutions clearance (K163579).

The KLS Mini Osteosynthesis System (K943347) has been included as a reference device to address the differences in screw dimensions from the reference device KLS Martin Individual Patient Solutions (K163579). In reference device K163579, screw dimensions range from 2.0 mm - 3.2 mm with lengths of 5 mm - 22 mm. The KLS Mini Osteosynthesis System has been included to cover the 1.5 mm screw dimensions and a minimum length down to 4 mm that is identical to the subject device temporary fixation screws.

The KLS Martin Centre-Drive Drill-Free Screw (K971297) has been included as a reference device to address the difference in screw dimension and style from the reference device KLS Martin Individual Patient Solutions (K163579). In reference device K163579, screw dimensions ranged from 2.0 mm - 3.2 mm with lengths of 5 mm - 22 mm and a drill-free screw style. The KLS Martin Centre-Drive Drill-Free Screw has been included to cover the 1.5 mm screw dimensions with a drill-free screw style that is identical to the subject device temporary fixation screws.

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KLS martın L.P.

11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com

	KLS Martin IPS PlanningSystem(Subject Device)	KLS Martin IPS PlanningSystemK181241(Primary Predicate)	KLS Martin IndividualPatient SolutionsK163579(Reference Device)	KLS Mini OsteosynthesisSystemK943347(Reference Device)	KLS Martin Centre-DriveDrill-Free ScrewK971297(Reference Device)
Indications for Use	The KLS Martin IndividualPatient Solutions (IPS)Planning System isintended for use as asoftware system and imagesegmentation system for thetransfer of imaginginformation from a medicalscanner such as a CT basedsystem. The input data fileis processed by the IPSPlanning System and theresult is an output data filethat may then be providedas digital models or used asinput to a rapid prototypingportion of the system thatproduces physical outputsincluding anatomicalmodels, guides, splints, andcase reports for use inmaxillofacial surgery. TheIPS Planning System is alsointended as a pre-operativesoftware tool forsimulating/ evaluatingsurgical treatment options.	The KLS Martin IndividualPatient Solutions (IPS)Planning System isintended for use as asoftware system and imagesegmentation system for thetransfer of imaginginformation from a medicalscanner such as a CT basedsystem. The input data fileis processed by the IPSPlanning System and theresult is an output data filethat may then be providedas digital models or used asinput to a rapid prototypingportion of the system thatproduces physical outputsincluding anatomicalmodels, guides, splints, andcase reports for use inmaxillofacial surgery. TheIPS Planning System is alsointended as a pre-operativesoftware tool forsimulating/ evaluatingsurgical treatment options.	KLS Martin IndividualPatient Solutions implantdevices are intended for usein the stabilization andfixation of mandibularfractures and mandibularreconstruction.	1) Fractures2) Osteotomies3) Reconstructionprocedures	KLS Martin Centre-DriveDrill-Free Screws areintended for use in rigidinternal fixation of the oral-maxillo-cranio-facial bones.The bone screws are used toanchor plates which arecontoured to fit the bonysurface and stabilize the bonefragments. The addition ofthe self drilling feature is theonly difference between thesubmitted device and thepredicate device referenced.
	KLS Martin IPS PlanningSystem(Subject Device)	KLS Martin IPS PlanningSystemK181241(Primary Predicate)	KLS Martin IndividualPatient SolutionsK163579(Reference Device)	KLS Mini OsteosynthesisSystemK943347(Reference Device)	KLS Martin Centre-DriveDrill-Free ScrewK971297(Reference Device)
Contraindications	1. Obvious infections.2. Hypersensitivity toforeign bodies.3. Circulatory problems,systemic diseases, andmetabolic disorders.4. Insufficient orinadequate bonetissue.5. Secondary diseasessuch as degenerativeprocesses that maynegatively influencethe healing process.6. Interventions carriedout in a non-sterileenvironment (e.g.paranasal sinuses).7. Regions exposed toinappropriate forcesor excessive weightloads.8. Patients unwilling orunable to followinstructions during thepostoperative phasedue to their mental,neurological, orphysical condition.9. Bone tumors locatedin the implant baseregion.	1. Obvious infections.2. Hypersensitivity toforeign bodies.3. Circulatory problems,systemic diseases, andmetabolic disorders.4. Insufficient orinadequate bonetissue.5. Secondary diseasessuch as degenerativeprocesses that maynegatively influencethe healing process.6. Interventions carriedout in a non-sterileenvironment (e.g.paranasal sinuses).7. Regions exposed toinappropriate forcesor excessive weightloads.8. Patients unwilling orunable to followinstructions during thepostoperative phasedue to their mental,neurological, orphysical condition.9. Bone tumors locatedin the implant baseregion.	1. Obvious infections.2. Hypersensitivity toforeign bodies.3. Suspected sensitivityto the implant material.4. Circulatory problems,systemic diseases andmetabolic disorders.5. Insufficient orinadequate bone tissue.6. Secondary diseasessuch as degenerativeprocesses that maynegatively influencethe healing process.7. Interventions carriedout in a non-sterileenvironment (e.g.paranasal sinuses).8. Regions exposed toinappropriate forces orexcessive weightloads.9. Patients unwilling orunable to followinstructions during thepostoperative phasedue to their mental,neurological orphysical condition.10. Osteoporosis orosteomalacia or other	1. Active infection.2. Patient conditionsincluding: blood supplylimitations, insufficientquantity or quality ofbone or latentinfections.3. Patients with mental orneurologic conditionswho are unwilling orincapable of followingpostoperative careinstructions.4. Foreign bodysensitivity. Wherematerial sensitivity issuspected, tests are tobe made prior toimplantation.	1. Active infection.2. Patient conditionsincluding: blood supplylimitations, insufficientquantity or quality ofbone or latentinfections.3. Patients with mental orneurologic conditionswho are unwilling orincapable of followingpostoperative careinstructions.4. Foreign bodysensitivity. Wherematerial sensitivity issuspected, tests are tobe made prior toimplantation.
	KLS Martin IPS PlanningSystem(Subject Device)	KLS Martin IPS PlanningSystemK181241(Primary Predicate)	KLS Martin IndividualPatient SolutionsK163579(Reference Device)	KLS Mini OsteosynthesisSystemK943347(Reference Device)	KLS Martin Centre-DriveDrill-Free ScrewK971297(Reference Device)
	10. Obvious drug oralcohol abuse.11. Significant changes tothe patient's anatomyhas occurred since themedical scan used forplanning purposeswas obtained.	10. Obvious drug oralcohol abuse.11. Significant changes tothe patient's anatomyhas occurred since themedical scan used forplanning purposeswas obtained.	structural bone damagepreventing the stablefixation of implantcomponents.11. Bone tumors located inthe implant baseregion.12. Obvious drug oralcohol abuse.
Classification	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 872.4760, Class II	21 CFR 872.4760, Class II	21 CFR 888.3040, Class II
Product Code	DZJ, LLZ	DZJ, LLZ	JEY	JEY	HRS
Target Population	Pediatric & Adults	Adolescent & Adult	Not applicable	Not applicable	Not applicable
Material	Anatomical Models:Epoxy/Resin, AcrylicCutting/Marking Guides:Polyamide, Titanium Alloy(Ti-6Al-4V), CP TitaniumSplints: methacrylate	Anatomical Models:Epoxy/Resin, AcrylicCutting/Marking Guides:Polyamide, Titanium Alloy(Ti-6Al-4V), CP TitaniumSplints: methacrylate	Anatomical Models:Epoxy/Resin, AcrylicImplants: CP Titanium &Titanium Alloy (Ti-6Al-4V)	Implants: CP Titanium &Titanium Alloy (Ti-6Al-4V)	Screws: Titanium Alloy(Ti-6Al-4V)
ManufacturingMethod	Epoxy/Resin, Acrylic:Stereolithography (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive;Selective Laser Melting)Polyamide: 3D (Additive;Selective Laser Sintering)	Epoxy/Resin, Acrylic:Stereolithography (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive;Selective Laser Melting)Polyamide: 3D (Additive;Selective Laser Sintering)	Epoxy/Resin, Acrylic:Stereolithography (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive;Selective Laser Melting)	CP Titanium & TitaniumAlloy (Ti-6Al-4V):Traditional (Subtractive)	Titanium Alloy (Ti-6Al-4V):Traditional (Subtractive)
	KLS Martin IPS PlanningSystem(Subject Device)	KLS Martin IPS PlanningSystemK181241(Primary Predicate)	KLS Martin IndividualPatient SolutionsK163579(Reference Device)	KLS Mini OsteosynthesisSystemK943347(Reference Device)	KLS Martin Centre-DriveDrill-Free ScrewK971297(Reference Device)
Sterilization	Non-sterile (Steam)	Non-sterile (Steam)	Non-sterile (Steam)	Non-sterile (Steam)	Non-sterile (Steam)
Temporary/PermanentScrew Diameter	Temporary: 1.5 mm – 2.7mm	Temporary: 1.5 mm – 2.7mm	Permanent: 2.0 mm - 3.2mm	Permanent: 1.5 mm - 2.0mm	Permanent: 1.0 mm - 2.0mm
Temporary/PermanentScrew Length	Temporary: 4 mm - 22 mm	Temporary: 4 mm - 22 mm	Permanent: 5 mm - 22 mm	Permanent: 4 mm - 19 mm	Permanent: 2 mm - 9 mm
Temporary/PermanentScrew Style	maxDrive & crossDrive(Drill-Free, locking[ThreadLock Taper Screw -TLTS])	maxDrive & crossDrive(Drill-Free, locking[ThreadLock Taper Screw -TLTS])	maxDrive & crossDrive(Drill-Free, locking[ThreadLock Taper Screw -TLTS])	maxDrive & crossDrive	Centre-Drive & crossDrive(Drill-Free)

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KLS martın L.P.

11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 ● 800-625-1557 ● Fax: 904-641-7378 www.klsmartinnorthamerica.com

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KLS martın L.P.

11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com

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KLS martın LP.

11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com

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Image /page/10/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the words "martin L.P." are in gray. The logo is simple and modern, and it is likely used to represent the company in a variety of contexts.

Non-Clinical Performance Data:

Tensile & Bending Testing

Tensile and bending tests leveraged from the primary predicate (K181241) were performed on the subject polyamide guides to demonstrate the subject devices made from polyamide can withstand multiple sterilization cycles without degradation and can maintain 85% of its initial tensile strength. This testing also provides evidence of shelf life for the subject polyamide guides in that the material will not degrade or the performance of the device will not be affected within the shelf life period. Shelf life period of the device is 6 months.

Tensile and bending tests for titanium were performed as outlined in the reference device, KLS Martin Individual Patient Solutions (K163579). Results of the testing demonstrate additively manufactured titanium devices are equivalent to, or better than, titanium devices manufactured using traditional (subtractive) methods. The subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device, K163579.

Biocompatibility Testing

Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, sensitization, irritation, and chemical/material characterization testing conducted on the subject devices manufactured from polyamide are within the pre-defined acceptance criteria, leveraged from the primary predicate KLS Martin Individual Patient Solutions (IPS) Planning System, K181241. The above biocompatibility tests were also conducted for titanium and are within the pre-defined acceptance criteria, as outlined in the reference device KLS Martin Individual Patient Solutions (K163579). The results of the testing adequately address biocompatibility for the output devices and their intended use.

Sterilization Testing

Steam sterilization validations were performed for each output device for the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 106 using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Validations for polyamide and titanium were leveraged from the predicate and reference devices, K181241 and K163579, respectively. Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device, K163579.

Pyrogenicity Testing

LAL endotoxin testing was conducted according to AAMI ANSI ST72 on the subject devices to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the KLS Martin IPS Planning System devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications. LAL endotoxin testing for titanium was leveraged from the reference device, KLS Martin Individual Patient Solutions (K163579). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device, K163579.

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Software Verification and Validation

Software verification and validation was performed on each individual software application that is used in the planning and design of the patient's images (CT). 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 system requirements. Testing required as a result of risk analysis 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 performs as intended based on the user requirements and specifications.

Clinical Performance Data:

Clinical testing was not necessary for the determination of substantial equivalence.

Conclusion:

The KLS Martin IPS Planning System shares identical technological characteristics and has the same intended use as the predicate device. A risk assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use in the pediatric subpopulations. Based on this risk assessment, expanding the patient population from adolescents and adults to include neonates, infants, and children does not identify new issues of safety or effectiveness, and concludes the subject device is substantially equivalent to the predicate device.

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11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com

510(k) Summary 21 CFR 807.92

Submitter:	KLS-Martin L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Pam Martin, RAC, MScRegulatory Affairs SupervisorPhone: 800-625-1557Email: pmartin@klsmartin.com
Date Prepared:	January 2, 2019
Trade Name:	KLS Martin Individual Patient Solutions (IPS) PlanningSystem
Common Name:	System for the creation of patient specific anatomicalmodels, cutting/marking guides, splints, and case reports
Classification Name:	Bone Cutting Instruments and Accessories (21 CFR872.4120); System, Image Processing, Radiological (21 CFR892.2050
Regulatory Class:	II
Product Code:	DZJ, LLZ
Predicate Device:	KLS Martin Individual Patient Solutions (IPS) PlanningSystem (K181241) - Primary
Reference Devices:	KLS Martin Individual Patient Solutions (K163579)KLS Mini Osteosynthesis System (K943347)KLS Martin Centre-Drive Drill-Free Screws (K971297)

Device Description:

Indications for Use:

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Technological Characteristics/Substantial Equivalence Discussion:

Similarities to Predicate

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Software Verification and Validation

Clinical Performance Data:

Clinical testing was not necessary for the determination of substantial equivalence.

Conclusion:

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.