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 computerized tomography (CT) medical scan. 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, and case reports for use in the marking and cutting of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

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 cranial 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, and case reports for use in the marking and cutting of cranial bone in cranial surgery.

AI/ML Overview

The provided text is a 510(k) summary for the KLS Martin Individual Patient Solutions (IPS) Planning System. It details the device, its intended use, and comparisons to predicate and reference devices. However, it does not describe specific acceptance criteria and a study dedicated to proving the device meets those criteria in the typical format of a diagnostic AI/ML device submission.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (K182889) and leveraging existing data from that predicate, as well as two reference devices (K182789 and K190229). The "performance data" sections describe traditional medical device testing (tensile, biocompatibility, sterilization, software V&V) and a simulated design validation testing and human factors and usability testing rather than a clinical study evaluating the accuracy of an AI/ML algorithm's output against a ground truth.

Specifically, there is no mention of:

Acceptance criteria for an AI/ML model's performance (e.g., sensitivity, specificity, AUC).
A test set with sample size, data provenance, or ground truth establishment details for AI/ML performance evaluation.
Expert adjudication methods, MRMC studies, or standalone algorithm performance.

The "Simulated Design Validation Testing" and "Human Factors and Usability Testing" are the closest sections to a performance study for the IPS Planning System, but they are not framed as an AI/ML performance study as requested in the prompt.

Given this, I will extract and synthesize the information available regarding the described testing and attempt to structure it to address your questions, while explicitly noting where the requested information is not present in the provided document.

Acceptance Criteria and Device Performance (as inferred from the document)

The document primarily states that the device passes "all acceptance criteria" for various tests, but the specific numerical acceptance criteria (e.g., minimum tensile strength, maximum endotoxin levels) and reported performance values are generally not explicitly quantified in a table format. The closest to "performance" is the statement that "additively manufactured titanium devices are equivalent or better than titanium devices manufactured using traditional (subtractive) methods."

Since the document doesn't provide a table of acceptance criteria and reported numerical performance for an AI/ML model's accuracy, I will present the acceptance criteria and performance as described for the tests performed:

Test Category	Acceptance Criteria (as described)	Reported Device Performance (as described)
Tensile & Bending Testing	Polyamide guides can withstand multiple sterilization cycles without degradation and can maintain 85% of initial tensile strength. Titanium devices must be equivalent or better than those manufactured using traditional methods.	Polyamide guides meet criteria. Additively manufactured titanium devices are equivalent or better than traditionally manufactured ones.
Biocompatibility Testing	All biocompatibility endpoints (cytotoxicity, sensitization, irritation, chemical/material characterization, acute systemic, material-mediated pyrogenicity, indirect hemolysis) must be within pre-defined acceptance criteria.	All conducted tests were within pre-defined acceptance criteria, adequately addressing biocompatibility.
Sterilization Testing	Sterility Assurance Level (SAL) of 10^-6 for dynamic-air-removal cycle. All test method acceptance criteria must be met.	All test method acceptance criteria were met.
Pyrogenicity Testing	Endotoxin levels must be below the USP allowed limit for medical devices that have contact with cerebrospinal fluid (< 2.15 EU/device) and meet pyrogen limit specifications.	Devices contain endotoxin levels below the USP allowed limit (< 2.15 EU/device) and meet pyrogen limit specifications.
Software Verification and Validation	All software requirements and specifications are implemented correctly and completely, traceable to system requirements. Conformity with pre-defined specifications and acceptance criteria. Mitigation of potential risks. Performs as intended based on user requirements and specifications.	All appropriate steps have been taken to ensure mitigation of any potential risks and performs as intended based on the user requirements and specifications.
Simulated Design Validation Testing	"Passed all acceptance criteria regardless of age or size" for representative cranial case extrapolated to six age ranges. Manufacturable at a high and acceptable level of fidelity, independent of feature size, age of patient, and device size.	Demonstrated that the subject devices passed all acceptance criteria regardless of age or size. Confirms manufacturability at a high and acceptable level of fidelity, independent of feature size, age of patient, and device size.
Human Factors and Usability Testing	No potential risks or concerns, outside of those previously raised and mitigated in the IFU, are found. Clinical experts confirm testing and outputs are applicable to real life situations and can be used to effectively execute a planned cranial procedure.	No potential risks or concerns were found (outside of those mitigated in IFU). All clinical experts confirmed the testing and outputs were applicable to real life situations and could be used to effectively execute a planned cranial procedure (pediatric or adult patients).

Detailed Study Information (Based on available text):

Sample size used for the test set and the data provenance:
- Test Set for Simulated Design Validation Testing: A "representative cranial case" was "extrapolated to six (6) distinct age ranges for input data (CT scan) equals output data validation." This implies 6 simulated cases were tested, but no further details on the number of actual CT scans or patients are provided.
- Test Set for Human Factors and Usability Testing: "Eighteen (18) cases were analyzed" (6 distinct age ranges, with outputs sent to 3 clinical experts, meaning 6 (age ranges) x 3 (experts) = 18 cases analyzed in total by the experts).
- Data Provenance: Not specified for the "representative cranial case" in simulated design validation. For human factors, it implicitly used outputs derived from the "six (6) distinct age ranges" based on the system's processing. The document does not specify if the data was retrospective or prospective, or the country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Simulated Design Validation Testing: Not explicitly stated that experts established ground truth for this test. It seems to be a technical validation against the design specifications.
- Human Factors and Usability Testing: "Three separate clinical experts" were used to review the outputs. Their qualifications are not specified beyond being "clinical experts." Their role was to analyze for potential use problems and make recommendations, and confirm applicability to real-life situations. This is not the establishment of ground truth in the sense of a diagnostic classification.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is described for either the simulated design validation or human factors/usability testing. The human factors testing involved reviews by multiple experts, but no process for reconciling disagreements or establishing a consensus "ground truth" among them is mentioned; they each provided independent feedback.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC comparative effectiveness study was not conducted according or described in this document. The device is not presented as an AI-assisted diagnostic tool that improves human reader performance in the traditional sense. It's a pre-operative planning system that processes CT data to create physical/digital outputs. The "Human Factors and Usability Testing" involved multiple readers (clinical experts) and multiple cases, but it was for usability assessment rather than a comparative effectiveness study of AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document describes "Software Verification and Validation" which is a form of standalone testing for the software applications used. It states that "all software requirements and specifications were implemented correctly and completely." However, this is a validation of the software's functionality and adherence to specifications, not a performance study of an AI/ML algorithm's accuracy in a diagnostic context. The system is explicitly described as requiring "trained employees/engineers who utilize the software applications to manipulate data and work with the physician to create the virtual planning session," indicating a human-in-the-loop process for generating the final outputs.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Simulated Design Validation Testing: The "ground truth" appears to be the "initial input data (.STL)" and the design specifications; the test verifies that "output data (CT scan) equals output data validation" (likely intended to mean input equals output, or input from CT leads to correct output).
- Human Factors and Usability Testing: The "ground truth" is effectively the "expert opinion" of the three clinical experts regarding the usability and applicability of the outputs, rather than a definitive medical diagnosis.
The sample size for the training set:
- The document describes the KLS Martin IPS Planning System as using "commercially off-the-shelf (COTS) software applications" (Materialise Mimics and Geomagic® Freeform PlusTM) for image segmentation and manipulation. This implies that the core algorithms were pre-existing and not developed by KLS Martin as a novel AI/ML model that would require a distinct training set outlined in this submission. Therefore, no information on a training set size is provided for the device.
How the ground truth for the training set was established:
- Not applicable, as no training set for a novel AI/ML model by KLS Martin is described. The COTS software validation would have been performed by their respective developers.

Summary

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August 31, 2020

KLS-Martin L.P. Katie Rutland Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246

Re: K201052

Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: PPT Dated: July 30, 2020 Received: July 31, 2020

Dear Katie Rutland:

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

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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 (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,

Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K201052

Device Name

KLS Martin Individual Patient Solutions (IPS) Planning System

Indications for Use (Describe)

The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

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) Summary21 CFR 807.92
Submitter:	KLS-Martin L.P.11201 Saint Johns Industrial Pkwy S.Jacksonville, FL 32246
Contact Person:	Katie RutlandRegulatory Affairs Project ManagerPhone: 800-625-1557Email: katie.rutland@klsmartin.com
Alternate Contact:	Melissa BachorskiRA/QMS ManagerPhone: 800-625-1557Email: RA_QA@klsmartin.com
Date Prepared:	August 31, 2020
510(k) Number:	K201052
Trade Name:	KLS Martin Individual Patient Solutions (IPS)Planning System
Common Name:	System for the creation of patient specific anatomicalmodels, cutting/marking guides, and case reports
Classification Name:	Cranial Surgical Planning and Instrument Guides (21 CFR882.4310)
Regulatory Class:	II
Product Code:	PPT
Predicate Device:	KLS Martin Individual Patient Solutions (IPS)Planning System (K182889)
Reference Devices:	KLS Martin Individual Patient Solutions (IPS) PlanningSystem (K182789)Stryker PEEK Customized Cranial Implant (K190229)

Device Description:

Indications for Use:

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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, and case reports for use in the marking and cutting of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Technological Characteristics/Substantial Equivalence Discussion:

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 (K188789):

The subject and predicate devices are intended for use as a software 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, and case reports. All digital data and physical devices are used to aid the surgeon during cranial surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The indications for use statement of the subject device is nearly identical to the predicate, K182889, differing in system outputs. The predicate, K182889, is cleared for use in the marking of bone in cranial surgery. The subject device is indicated for the marking and cutting of cranial bone in cranial surgery. The potential impact on substantial equivalence with regard to each technological difference has been addressed through risk analysis as well as verification and validation testing.

Similarities to Predicate

The subject and predicate devices share the same fundamental principle of operation - a system that processes original patient medical images (CT scan) and produces a variety of patient-specific physical and/or digital output devices for planning and executing cranial surgery.

The subject device shares identical technological characteristics as the predicate regarding software, material manufacturing process, performance testing, as well as cleaning and sterilization.

Both the subject and predicate devices use image data obtained from CT scans. The subject device utilizes two (2) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation identical to what was evaluated in the predicate device, K182889. The validated commercially off-theshelf (COTS) software applications are used 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.

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

Design validation activities to verify the final finished output device matches the initial input data (.STL) are identical to the predicate and reference devices, K182889

and K182789.

Materials used in the manufacture of the subject output devices are polyamide, acrylic resins, and titanium (CP titanium & Titanium Alloy) identical to what was evaluated in the predicate device, K182889.

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 10-6.

Differences from Predicate

The subject device's indications for use is nearly identical to the predicate device, differing in system outputs. The predicate, K182889, is cleared for use in the marking of bone in cranial surgery. The subject device is indicated for the marking and cutting of cranial bone in cranial surgery.

The IPS Planning System includes cutting and positioning guides, whereas the predicate only includes marking guides. Cutting and positioning guides were included as part of this device system to aid in cranial pediatric surgeries (e.g., craniosynostosis, congenital cranial deformities, etc.).

The predicate patient population includes adults only, whereas the subject device includes pediatric (neonate, infant, children, adolescents) and adult patient populations.

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

Reference Devices

The KLS Martin Individual Patient Specific Planning System, K182789, and the Stryker PEEK Customized Cranial Implant Kit, K190229 have been included as reference devices to address differences in technological characteristics between the subject and predicate devices.

o Target Population: The predicate device was cleared for use in the adult patient population only, whereas the subject device includes pediatric (neonate, infant, children, adolescents) and adult patient populations, which is similar to the reference devices. K182789 includes all pediatric subpopulations and adults, while K190229 includes patients 3.5 years of age and older. Risk mitigation studies for pediatric patients were completed in both reference devices along with verbiage provided in the labelling to mitigate any risks (i.e., radiation exposure).

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Device Comparison Table
	KLS Martin IPS Planning System(Subject Device)	KLS Martin IPS Planning SystemK182889(Primary Predicate)	KLS Martin IPS Planning SystemK182789(Reference)	Stryker PEEK CustomizedCranial Implant KitK190229(Reference)
Indications for Use	The KLS Martin Individual PatientSolutions (IPS) Planning System isintended for use as a software systemand image segmentation system forthe transfer of imaging informationfrom a computerized tomography(CT) medical scan. The input datafile is processed by the IPS PlanningSystem and the result is an outputdata file that may then be providedas digital models or used as input toa rapid prototyping portion of thesystem that produces physicaloutputs including anatomicalmodels, guides, and case reportsfor use in the marking and cuttingof cranial bone in cranial surgery.The IPS Planning System is alsointended as a pre-operativesoftware tool for simulating /evaluating surgical treatmentoptions. Informationprovided by the softwareand device output is not intendedto eliminate, replace, orsubstitute, in whole or in part, thehealthcare provider's judgment andanalysis of the patient's condition.	The KLS Martin Individual PatientSolutions (IPS) Planning System isintended for use as a softwaresystem and image segmentationsystem for the transfer of imaginginformation from a computerizedtomography (CT) medical scan. Theinput data file is processed by theIPS Planning System and the resultis an output data file that may thenbe provided as digital models orused as input to a rapid prototypingportion of the system that producesphysical outputs includinganatomical models, guides and casereports for use in the marking ofcranial bone in cranial surgery. TheIPS Planning System is alsointended as a pre-operative softwaretool for simulating / evaluatingsurgical treatment options.	The KLS Martin Individual PatientSolutions (IPS) Planning 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 theIPS Planning System and the resultis an output data file that may thenbe provided as digital models orused as input to a rapid prototypingportion of the system that producesphysical outputs includinganatomical models, guides, splints,and case reports for use inmaxillofacial surgery. The IPSPlanning System is also intended asa pre-operative software tool forsimulating / evaluating surgicaltreatment options.	The PEEK Customized CranialImplant Kit is indicated for theaugmentation and/or restoration ofbony and/or soft tissue deformitiesin the cranial and craniofacialskeleton (orbital rim, zygoma, andadjacent bone); including but notlimited to, the correction andprevention of persistent temporalhollowing (PTH) in patients 3.5years of age and older.
Device Comparison Table
	KLS Martin IPS Planning System(Subject Device)	KLS Martin IPS Planning SystemK182889(Primary Predicate)	KLS Martin IPS Planning SystemK182789(Reference)	Stryker PEEK CustomizedCranial Implant KitK190229(Reference)
Contraindications	1. Obvious infections.2. Hypersensitivity to foreignbodies.3. Circulatory problems, systemicdiseases, and metabolicdisorders.4. Insufficient or inadequate bonetissue.5. Secondary diseases such asdegenerative processes that maynegatively influence the healingprocess.6. Interventions carried out in anon-sterile environment (e.g.paranasal sinuses).7. Regions exposed to inappropriateforces or excessive weight loads.8. Patients unwilling or unable tofollow instructions during thepostoperative phase due to theirmental, neurological, or physicalcondition.9. Bone tumors located in theimplant base region.10. Obvious drug or alcohol abuse.11. Significant changes to thepatient's anatomy has occurredsince the medical scan used forplanning purposes was obtained.	1. Obvious infections.2. Hypersensitivity to foreignbodies.3. Circulatory problems, systemicdiseases, and metabolicdisorders.4. Insufficient or inadequate bonetissue.5. Secondary diseases such asdegenerative processes that maynegatively influence the healingprocess.6. Interventions carried out in anon-sterile environment (e.g.paranasal sinuses).7. Regions exposed to inappropriateforces or excessive weight loads.8. Patients unwilling or unable tofollow instructions during thepostoperative phase due to theirmental, neurological, or physicalcondition.9. Bone tumors located in theimplant base region.10. Obvious drug or alcohol abuse.11. Significant changes to thepatient's anatomy has occurredsince the medical scan used forplanning purposes was obtained.	1. Obvious infections.2. Hypersensitivity to foreignbodies.3. Circulatory problems, systemicdiseases, and metabolicdisorders.4. Insufficient or inadequate bonetissue.5. Secondary diseases such asdegenerative processes that maynegatively influence the healingprocess.6. Interventions carried out in anon-sterile environment (e.g.paranasal sinuses).7. Regions exposed to inappropriateforces or excessive weight loads.8. Patients unwilling or unable tofollow instructions during thepostoperative phase due to theirmental, neurological, or physicalcondition.9. Bone tumors located in theimplant base region.10. Obvious drug or alcohol abuse.11. Significant changes to thepatient's anatomy has occurredsince the medical scan used forplanning purposes was obtained.	Unknown
Device Comparison Table
	KLS Martin IPS Planning System(Subject Device)	KLS Martin IPS Planning SystemK182889(Primary Predicate)	KLS Martin IPS Planning SystemK182789(Reference)	Stryker PEEK CustomizedCranial Implant KitK190229(Reference)
Classification	21 CFR 882.4310, Class II	21 CFR 882.4310, Class II	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 882.5320, Class II
Product Code	PPT	PPT	DZJ, LLZ	GWO
Material	Anatomical Models: Epoxy/Resin,AcrylicCutting/Marking Guides:Polyamide, Ti-6Al-4V, CPTitanium	Anatomical Models: Epoxy/Resin,AcrylicCutting/Marking Guides:Polyamide, Ti-6Al-4V, CPTitanium	Anatomical Models: Epoxy/Resin,AcrylicCutting/Marking Guides: PA, Ti6Al-4V, CP TitaniumSplints: methacrylate	Polyether ether ketone (PEEK)
ManufacturingMethod	Epoxy/Resin, Acrylic: 3D (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive: SLM)Polyamide: 3D (Additive; SLS)	Epoxy/Resin, Acrylic: 3D (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive; SLM)Polyamide: 3D (Additive; SLS)	Epoxy/Resin, Acrylic: 3D (SLA)CP Titanium: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive: SLM)Polyamide: 3D (Additive; SLS)	Unknown
Software	Materialise Mimics (K073468)Geomagic® Freeform PlusTM	Materialise Mimics (K073468)Geomagic® Freeform PlusTM	Materialise Mimics (K073468)Geomagic® Freeform PlusTMIPS CaseDesigner (K161634)MathWorks® MATLAB	Unknown
Target Population	Pediatric & Adult	Pediatric & Adult	Pediatric & Adult	Pediatric & Adult
Sterilization	Non-sterile (steam)	Non-sterile (steam)	Non-sterile (steam)	Non-sterile (steam)
Anatomical Sites	Cranial	Cranial	Mandibular and Maxillofacial	Cranial
Thickness	Cutting/Marking GuideMin: 1.0 mmMax: 5 mm	Cutting/Marking GuideMin: 1.0 mmMax: 5 mm	Cutting/Marking GuideMin: 1.0 mmMax: 5.0 mm	Not applicable
Device Comparison Table
	KLS Martin IPS Planning System(Subject Device)	KLS Martin IPS Planning SystemK182889(Primary Predicate)	KLS Martin IPS Planning SystemK182789(Reference)	Stryker PEEK CustomizedCranial Implant KitK190229(Reference)
Width	Cutting/Marking GuideMin: 7 mmMax: 200 mm	Cutting/Marking GuideMin: 7 mmMax: 200 mm	Cutting/Marking GuideMin: 7 mmMax: 200 mm	Not applicable
Length	Cutting/Marking GuideMin: 15 mmMax: 350 mm	Cutting/Marking GuideMin: 15 mmMax: 350 mm	Cutting/Marking GuideMin: 15 mmMax: 350 mm	Not applicable
Degree of curvature(in-plane)	Cutting/Marking GuideMin: 90°Max: 180°	Cutting/Marking GuideMin: 90°Max: 180°	Cutting/Marking GuideMin: 90°Max: 180°	Not applicable
Degree of curvature(out-of-plane)	Cutting/Marking GuideMin: 60°Max: 180°	Cutting/Marking GuideMin: 60°Max: 180°	Cutting/Marking GuideMin: 60°Max: 180°	Not applicable
Screw hole spacing	Cutting/Marking GuideMin: ≥4.5 mmMax: No Max	Cutting/Marking GuideMin: ≥4.5 mmMax: No Max	Cutting/Marking GuideMin: ≥4.5 mmMax: No Max	Not applicable
No. of holes	Cutting/Marking GuideMin: 2Max: Depends on length and holespacing	Cutting/Marking GuideMin: 2Max: Depends on length and holespacing	Cutting/Marking GuideMin: 2Max: Depends on length and holespacing	Not applicable
Screw Diameter	Temporary: 1.0 mm - 2.7 mm	Temporary: 1.0 mm - 2.7 mm	Temporary: 1.5 mm - 2.7 mm	Not applicable
Screw Length	Temporary: 2 mm - 11 mm	Temporary: 2 mm - 11 mm	Temporary: 4 mm - 22 mm	Not applicable
Screw Style	maxDrive & crossDrive (Drill-Free,non-locking)	maxDrive & crossDrive (Drill-Free, locking [ThreadLockTaper Screw -TLTS])	maxDrive & crossDrive (Drill-Free, non-locking, locking, TLTS	Not applicable

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Non-Clinical Performance Data

Tensile & Bending Testing

Tensile and bending tests 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. This testing is identical to the predicate device and is leveraged from K182889.

Tensile and bending tests for titanium were performed as outlined in the predicate device. K182889. Results of the testing demonstrate additively manufactured titanium devices are equivalent 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 predicate device and is leveraged from K182889.

Biocompatibility Testing

Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, sensitization, irritation, chemical/material characterization, acute systemic, material-mediated pyrogenicity, and indirect (extract) hemolysis testing conducted on the subject devices were within the pre-defined acceptance criteria, and therefore, adequately addresses biocompatibility for the output devices and their intended use. Biocompatibility testing is identical to the predicate device and is leveraged from K182889.

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. Sterilization testing is identical to the predicate device and is leveraged from K182889.

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 that have contact with cerebrospinal fluid (< 2.15 EU/device) and meet pyrogen limit specifications. Pyrogenicity testing is identical to the predicate device and is leveraged from K182889.

Software Verification and Validation

Software verification and validation was performed on each individual software application used in the planning and design of the output devices derived from the patient's images (CT). Ouality 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 which was required as a result of risk and impact assessments, showed conformity with pre-defined specifications and acceptance

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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. Software verification and validation is identical to the predicate device and is leveraged from K182889.

Simulated Design Validation Testing

Simulated design validation testing was performed using a representative cranial case that was extrapolated to six (6) distinct age ranges for input data (CT scan) equals output data validation. Testing demonstrated that the subject devices passed all acceptance criteria regardless of age or size. Furthermore, it confirms the subject devices to be manufacturable at a high and acceptable level of fidelity, independent of feature size, age of patient, and device size.

Human Factors and Usability Testing

Simulated human factors and usability testing was performed using clinical expert review to analyze the device output across all age ranges for potential use problems and to make recommendations. These output devices (guides, models, and case reports) for each age range (6 total) were sent to three separate clinical experts. In total, eighteen (18) cases were analyzed and the results showed that no potential risks or concerns, outside of those previously raised and mitigated in the IFU, were found. All clinical experts confirmed the testing and outputs were applicable to real life situations and could be used to effectively execute a planned cranial procedure, whether it be in pediatric patients or adult patients.

Clinical Evaluation

Clinical studies and findings found in peer-reviewed literature show the potential benefits associated with the use of the subject device outweigh the potential risks associated with its use. Scientific peer-reviewed publications describing the safe and effective application of virtual surgical planning in pediatric and adult patients are provided within this submission.

Conclusions

The KLS Martin IPS Planning System has the same intended use and similar technological characteristics as the predicate device. Technological differences have been addressed through performance data from the predicate and reference devices, in addition to validated simulated use testing and analysis of peer-reviewed clinical studies. All information provided show the safe and effective use of the subject device for the intended patient population.

In conclusion, the potential benefits associated with the use of the subject device outweigh its potential risks for the targeted patient population. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein. it is concluded that the information included in this submission supports substantial equivalence.

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).