The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for multi-unit prostheses, such as dentures.

Device Description

The KLS Martin Individual Patient Solutions (IPS) Preprosthetic system is comprised of patient-specific models and metallic bone plates with integrated pillars used in conjunction with metallic bone screws for internal fixation of the implant to maxillofacial / midface and mandibular bones. The integrated pillars will serve as the base for temporary dentures as well as a permanent prosthesis. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

The KLS Martin IPS Planning System is utilized to plan and design the IPS Preprosthetic implant. The 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, implants, and case reports.

Implants are provided non-sterile, range in thickness from 1.2 - 10.0 mm, and are manufactured using additive methods from Ti-6Al-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws.

Implants have a minimum of two (2) transgingival pillars for the attachment of dental prostheses. The straight pillars (0° to the occlusal plane) have a diameter of 4 mm and are provided at lengths up to 20 mm.

AI/ML Overview

The provided document is a 510(k) summary for the KLS Martin IPS Preprosthetic device and does not contain information about acceptance criteria for an AI/CADe device, nor does it detail a study proving such a device meets those criteria. The device described, the KLS Martin IPS Preprosthetic, is a patient-specific subperiosteal dental implant, not an AI or CADe system.

Therefore, I cannot extract the requested information regarding:

A table of acceptance criteria and reported device performance for an AI/CADe system.
Sample size used for the test set and data provenance for an AI/CADe system.
Number of experts and their qualifications used to establish ground truth for an AI/CADe system.
Adjudication method for the test set of an AI/CADe system.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study for an AI/CADe system.
Standalone performance for an AI/CADe system.
Type of ground truth used for an AI/CADe system.
Sample size for and establishment of ground truth for the training set of an AI/CADe system.

The document does mention "Software Verification and Validation" on page 10, stating:
"Software verification and validation was performed on individual software applications that are used in the planning and design of the implant based on 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."

This section indicates that there was software used in the planning and design of the implant, which is based on CT images. This software underwent verification and validation, including "user acceptance testing" and conformity with "pre-defined specifications and acceptance criteria." However, it does not provide the specifics of these acceptance criteria, the study design, or any performance metrics in the format requested for an AI/CADe system. It is a general statement about software V&V, not a study proving the performance of an AI-driven diagnostic or CADe device in a clinical context.

The "Performance Testing - Clinical" section (page 11) discusses the clinical outcomes of the implant device itself (implant loosening, reduced post, exposed/removed screws, infections/abscesses, partial exposure of underlying framework), not the performance of any AI or CADe software used in its design.

Summary

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

Re: K210228

Trade/Device Name: KLS Martin IPS Preprosthetic Regulation Number: 21 CFR 872.3645 Regulation Name: Subperiosteal Implant Material Regulatory Class: Class II Product Code: ELE Dated: June 1, 2022 Received: June 7, 2022

Dear Susan Leander:

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/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 medical devices and radiation-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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210228

Device Name

KLS Martin IPS Preprosthetic

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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Image /page/3/Picture/1 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 slightly 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

Section 5

510(k) Summary 21 CFR 807.92

Submitter:	KLS-Martin L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Susan LeanderRegulatory Affairs Project SupervisorPhone: 800-625-1557Email: susan.leander@klsmartin.com
Alternate Contact:	Melissa BachorskiAssistant Director RA/QMSPhone: 800-625-1557Email: melissa.bachorski@klsmartin.com
Date Prepared:	July 7, 2022
Trade Name:	KLS Martin IPS Preprosthetic
Common Name:	Dental implant
Classification Name:	Implant, subperiosteal (21 CFR 872.3645)
Regulatory Class:	II
Product Code:	ELE
Predicate Device:	Hollow Basket Titanium Dental Implant (K801208)
Reference Devices:	Pacific Implants Intraosseous Dental Implant (K813227)KLS Martin Individual Patient Solutions (K191028)

Device Description

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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, implants, and case reports.

Indications for Use

Technological Characteristics & Substantial Equivalence Discussion

The intended use of the subject device, KLS Martin IPS Preprosthetic is similar to the predicate device, K801208 and the reference device, K813227. The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing.

Similarities to Predicate

The subject and predicate devices are intended to be used to provide support for prosthetic devices. Both are subperiosteal implants made of titanium that are surgically placed in the upper or lower jaw to support prostheses. Both devices have transgingival pillars for the attachment of prostheses.

The subject and predicate devices are safe and effective at restoring a patient's chewing function when the maxilla and/or mandible have been compromised.

The subject device is provided non-sterile and requires the end-user to process the implants using validated cleaning and sterilization methods prior to use as recommended in the labeling. Sterilization information is not available for the predicate device.

Differences from Predicate

The subject and predicate devices are attached to the bony substructures of the jaw. The predicate device is an intraosseous implant whereas the subject device is implanted using bone screws to attach the device to the bone. Although attachment to the bone is achieved differently, both are effective methods. Studies of the predicate device present evidence of osseointegration that results in stable attachment of the implant. The attachment method used by the subject device has been safely and effectively demonstrated in more than one hundred clinical cases in the EU, where the device is currently marketed. Real-world evidence of the subject device's safe and effective use is cited in peer-reviewed literature.

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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 the word "martin" is in gray. The letters "L.P." are in black.

Reference Devices

KLS Martin Individual Patient Solutions (K191028), included as a reference device, is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of maxillofacial / midface and mandibular bones.

Both the subject and reference devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Subject and reference device implants are provided non-sterile and are manufactured using additive methods from Ti-6Al-4V. These patient-specific devices are fixated with previously cleared KLS Martin screws.

The Pacific Implant, Inc. Endosseous Dental Implant (K813227) has been included as a reference device for comparison of typical loading values for dental implants. The subject and reference devices are intended to be used to provide support for prosthetic devices. Both are made of titanium; both are surgically placed in the upper or lower jaw and both are devices to support prostheses. Both devices have transgingival pillars for the attachment of prostheses. Both devices are designed for use in patients that have sub-optimal quantity or quality of bone in the upper or lower jaw.

Both the subject and reference devices are safe and effective at restoring a patient's chewing function when the jawbone has been compromised.

The subject and reference devices are provided non-sterile and require the end-user to process the implants using validated cleaning and sterilization methods prior to use as recommended in the labeling.

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kıs martı 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

Device Comparison Table
	KLS Martin IPS PreprostheticK210228	Hollow Basket Titanium DentalImplantsK801208	Pacific Implant, Inc. Intraosseous DentalImplantK813227	KLS Martin Individual Patient SolutionsK191028
	(Subject Device)	(Primary Predicate)	(Reference Device)	(Reference Device)
Indications for Use	The KLS Martin IPS Preprosthetic Implant is a subperiosteal implantcomposed of titanium intended to construct patient specificprosthetic devices which are surgically implanted into the lower orupper jaw between the periosteum (connective tissue covering thebone) and supporting bony structures. The device is intended toprovide support for multi-unit prostheses, such as dentures.	The Hollow Basket Titanium DentalImplant is a subperiosteal implantcomposed of titanium intended toconstruct patient specific prostheticdevices which are surgically implantedinto the lower or upper jaw between theperiosteum (connective tissue covering thebone) and supporting bony structures.	An endosseous dental implant is aprescription device made of a material such astitanium or titanium alloy that is intended tobe surgically placed in the bone of the upperor lower jaw arches to provide support forprosthetic devices, such as artificial teeth, inorder to restore a patient's chewing function.¹	The KLS Martin Individual Patient Solutionsimplant devices are intended for use in thestabilization, fixation, and reconstruction of themaxillofacial / midface and mandibular skeletalregions.
Contraindications	1. Obvious infections2. Hypersensitivity to foreign bodies3. Suspected sensitivity to the implant material4. Circulatory problems, systemic diseases and metabolicdisorders5. Insufficient or inadequate bone tissue6. Secondary diseases such as degenerative processes that maynegatively influence the healing process7. Interventions carried out in a non-sterile environment (e.g.paranasal sinuses)8. Regions exposed to inappropriate forces or excessive weightloads9. Patients unwilling or unable to follow instructions during thepostoperative phase due to their mental, neurological orphysical condition10. Osteoporosis or osteomalacia or other severe structural bonedamage preventing the stable fixation of implant components11. Bone tumors located in the implant base region12. Obvious drug or alcohol abuse13. Failure to locate a primary nerve in the lower jaw14. Uncontrolled Type II diabetes15. Oral or intravenous bisphosphonates16. Bruxism (tooth grinding or clenching)17. Smoking	Unknown – similar to K813227	1. Local tissue or existing dentitiondegeneration due to²:a. Excessive mobilityb. Loss of integrationc. Incompatibility of the devicecomponentsd. Structural failure of the device2. Pain3. Infection4. Adverse tissue reaction5. Bone or nerve damagea. Sinus perforationb. Alveolar plate perforationc. Transient or chronic pain/facialparesis6. Migration or thermal injurya. Incompatibility with MRI7. Patient Selection Criteriaa. Previous radiation therapy (affectsbone quality)	1. Obvious infections.2. Hypersensitivity to foreign bodies.3. Suspected sensitivity to the implantmaterial.4. Circulatory problems, systemic diseases,and metabolic disorders.5. Insufficient or inadequate bone tissue.6. Secondary diseases such as degenerativeprocesses that may negatively influence thehealing process.7. Interventions carried out in a non-sterileenvironment (e.g. paranasal sinuses).8. Regions exposed to inappropriate forces orexcessive weight loads.9. Patients unwilling or unable to followinstructions during the postoperative phasedue to their mental, neurological, orphysical condition.10. Osteoporosis or osteomalacia or otherstructural bone damage preventing thestable fixation of implant components.11. Bone tumors located in the implant baseregion.12. Obvious drug or alcohol abuse.
Patient-specific?	Yes. Devices are manufactured patient-specific, based on a CT scanof the patient.		No.	Yes. Devices are manufactured patient-specific,based on a CT scan of the patient.
Classification	21 CFR 872.3645Class II		21 CFR 872.3640Class II	21 CFR 872.4760Class II
Product Code	ELE		DZE	JEY
Material	Anatomical Models: Epoxy/Acrylic Resins Implants: Ti-6Al-4V		Implants: CP Titanium	Anatomical Models: Epoxy/Acrylic Resins Cutting/Marking Guides: Polyamide,Ti-6Al-4V, CP Titanium Splints: acrylic/methacrylic resins
ManufacturingMethod	Epoxy/Acrylic Resins: Stereolithography (SLA) Ti-6Al-4V: 3D (Additive; Selective Laser Melting)		Traditional milling/stamping	Epoxy/Acrylic Resins: Stereolithography(SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective LaserMelting) Polyamide: 3D (Additive; Selective LaserSintering)
Sterilization	Unknown		Non-sterile	Non-sterile
Anatomical Sites	Maxillofacial/Midface & Mandible		Mandible	Maxillofacial / Midface & Mandible
Plate Specifications
Thickness	1.2 mm - 10.0 mm		Unknown	Orbital floor only: 0.3 mm – 1.0 mm Maxillofacial / midface reconstruction:0.6 mm - 10.0 mm Mandibular reconstruction: 1.0 mm - 3.0 mm
Style	Non-lockingCompressionThreaded		One-piece hollow, grooved, bore-holedcylinders with upper portions designed tosupport an artificial denture	Non-lockingCompressionThreaded
Width(between screws)	Min: 4.5 mm		No screws are used with this device	Maxillofacial / midface:Min: ≥ 4.5 mm (around screw holes)Min: ≥ 3 mm (not around screw hole)Max: Dependent on screw-holeMandibular:Min: 7 mmMax: 8.5 mm
Length	Maxillofacial / midface:Min: 29 mmMax: 320 mmMandibular:Min: 29 mmMax: 320 mm		Unknown	Maxillofacial / midface:Min: 18 mmMax: 350 mmMandibular:Min: 31 mmMax: 320 mm
Width aroundScrews	1.5 System: ≥ 4.5 mm2.0/2.3 System: ≥ 6.5 mm2.7 System: ≥ 8 mm	No screws are used with this device	No screws are used with this device	1.5 System: ≥ 4.5 mm2.0/2.3 System: ≥ 6.5 mm2.7 System: ≥ 8 mm
Number of ScrewHoles	Maxillofacial / midface:Min: 4 per side of defectMax: Dependent on length & hole spacingMandibular:Min: 4Max: Dependent on length & hole spacing	Holes are present but are not screw holes.These are to allow for bone ingrowth.	14 holes are present but are not screw holes.These are to allow for bone ingrowth.	Maxillofacial / midface:Min: ≥ 2 per side of defectMax: Dependent on length & hole spacingMandibular:Min: 4Max: Dependent on length & hole spacing
Pillar Diameter	≥ 4 mm	Unknown	N/A	N/A
Angulation ofPillar to theOcclusal Plane	0°	Unknown	N/A	N/A

1 21 CFR 872.3640 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=872.3640

4 https://www.acabine-i.org/7992017041519222 http://www.fitest.com/itesMecine/MedialDevices/drives/drives/drives/drive/com/tree/Doml/Poduct/Poduct/Part/2012/21/201

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Kıs martın ı.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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Kıs 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

Screw Specifications
Screw Diameter	1.5 mm – 3.2 mm	Not applicable	Not applicable	Maxillofacial / midface1.5 mm – 2.3 mmMandibular:2.0 mm – 3.2 mm
Screw Length	3.5 mm – 21 mm	Not applicable	Not applicable	Maxillofacial / midface3.5 mm – 22 mmMandibular:5 mm – 22 mm
Screw Style	maxDrive (Drill-Free, locking, [ThreadLock Taper Screw – TLTS])	Not applicable	Not applicable	maxDrive & crossDrive (Drill-Free, locking[ThreadLock Taper Screw -TLTS])

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Image /page/9/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 slightly larger than the word "martin."

Performance Testing - Non-clinical

MR Conditional Labeling

Non-clinical worst-case MRI review was performed to evaluate the metallic IPS Preprosthetic devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (dental implants and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.

Additive Manufacturing Build Orientation & Location

Baseline Study - Build Orientation (#PBN-0478)

A baseline study was conducted to demonstrate that placement on the bed has minimal impact on the final component in terms of dimensional accuracy from the build.

Fourteen (14) Selective Laser Melting (SLM) test articles, identical to the final finished device with regard to processing, were used to examine the influence of various bed positions and any effect of component dimensional accuracy using FEM analysis. The results indicate that components placed centrally vs. peripherally have minor impact on the final component.

Position and Tensile Strength (#PBN-0481)

Additional studies were performed to determine whether build location in the build space has a significant effect on device characteristics or performance. The baseline study performed on the SLM test articles demonstrates that the components achieved a tensile strength of 860 N/mm2 and component position does not significantly impact tensile strength.

SLM Orientation and Tensile Strength (#PBN-0474)

Various component orientations (Z, 45° tilted, 45° horizontal, Y, and X) were evaluated to ensure the SLM test articles met the 860 N/mm² requirement for tensile strength in accordance with ASTM F136. All test setups rendered similar values for the various orientations tested, which exceeded the 860 N/mm² requirement for tensile strength per ASTM F136.

Dimensional Evaluation of Worst-Case Model (#IRN-0004)

A full validation to address a worst-case design of the subject device in terms of the accuracy of the final device as compared to the initial software model design was performed. An evaluation of a worst-case implant device was evaluated using a 3D scanner to determine the dimensions of each manufactured part. An STL of the scanned part was created and compared against the original software model design. The test report results show that deviations of the manufactured part versus the associated original model design file are well within the acceptance criteria. All samples passed the acceptance criteria of deviation relative to nominal part by not exceeding the maximum tolerance of ±1.5 mm. These results indicate that Ti-6AL-4V parts manufactured implants within their specification range meet dimensional requirements for fit and function of the devices as defined by the model.

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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 word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern.

Material Characterization

Powder Recycling Process and Evaluation of Device Performance (#PBN-0484)

An assessment of the material recycling protocol was conducted to determine the effect of material recycling on the properties of the final finished device. The analysis demonstrated the material recycling process, tested with 256 SLM test articles over the course of one year, yielded consistent tensile strength results.

Biocompatibility Testing

Biocompatibility endpoints were evaluated in accordance with ISO 10993. The battery of cytotoxicity, chemical analysis, sensitization and irritation, and chemical/material characterization testing was leveraged from the reference device, KLS Individual Patient Solutions (K191028), for titanium devices. The subject device is identical to the reference device in final finished form, which includes material formulations, manufacturing methods and processes, and sterilization methods. No other chemicals have been added (e.g., fillers, additives, cleaning agents). Therefore, this adequately addresses biocompatibility for the subject device system.

Sterilization Testing

Steam sterilization validations were performed using the dynamic-air-removal cycle in accordance with AAMI ANSI ISO 17665-1 to a sterility assurance level (SAL) of 10th using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Validations for devices manufactured from titanium were leveraged from the reference device, KLS Martin Individual Patient Solutions (K191028). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device.

Pyrogenicity Testing

LAL endotoxin testing was conducted according to AAMI ANSI ST72 to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the subject 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 predicate device, KLS Martin Individual Patient Solutions (K191028). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device.

Software Verification and Validation

Software verification and validation was performed on individual software applications that are used in the planning and design of the implant based on 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.

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Image /page/11/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 smaller than the other letters in the logo.

Performance Testing - Clinical

Clinical testing data of IPS Preprosthetic was collected up to 74 months post-operatively which evaluated 39 total implants from 35 patients. The data consisted of 19 patients who received implants due to postablative maxillary defects, 10 patients who received implants to treat a severely atrophic maxilla, and 6 patients who were treated for a cleft lip and palate (CLP) deformity with significant soft and hard tissue impairment. Of the 39 implants, there were no instances of implant loosening (0%) or a removed implant (0%). There was one instance of a reduced post (2.9%), 3 instances of exposed/removed screws (8.6%), 3 instances of infections/abscesses (8.6%), and 14 instances of a partial exposure of underlying framework (40%).

Substantial Equivalence Conclusion

KLS Martin IPS Preprosthetic has the same intended use, same fundamental principles of operation, and similar technological features compared to the predicate device. Any differences in technological features between the subject and predicate devices do not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 872.3645 Subperiosteal implant material.

(a)
Identification. Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.(b)
Classification. Class II.