(336 days)
KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of mandibular bone. 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 device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. Implants are provided non-sterile, range in thickness from 1.0 - 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.
Here's a summary of the acceptance criteria and study information for the KLS Martin Individual Patient Solutions device, based on the provided document:
This document focuses on the mechanical and material performance of the device rather than the performance of an AI algorithm in a diagnostic or clinical decision support context. Therefore, many of the typical AI/ML study questions (like effect size of human readers with/without AI, standalone algorithm performance, number of experts for ground truth, etc.) are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Mechanical Performance (Bending Properties per ASTM F382) | The bending resistance and fatigue life of the subject devices (additive manufactured) were determined to be equivalent or better than the predicate devices (subtractive manufactured). |
| Sterilization Validation (Steam Sterilization per ISO 17665-1:2006) | Validation performed for the dynamic-air-removal cycle to a sterility assurance level (SAL) of $10^{-6}$ using the biological indicator (BI) overkill method. All test method acceptance criteria were met. |
| Biocompatibility (per ISO 10993) | The battery of cytotoxicity, chemical analysis, sensitization and irritation, and chemical/material characterization testing conducted on the subject device were within the pre-defined acceptance criteria, and therefore, adequately addresses biocompatibility for implants with a permanent duration of contact. |
| Verification of Patient-Specific Design | For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. (This is a design verification process, not clinical performance for the manufactured implant). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of number of physical devices or specific data points for performance testing. The document refers to "the subject plates" for mechanical testing, implying a representative sample was tested.
- Data Provenance: The studies are non-clinical bench tests and conducted by the manufacturer, KLS Martin LP. The data originates from these laboratory tests, not from patient data or clinical settings. It is a retrospective analysis of device performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This device is a medical implant, not a diagnostic AI device. There is no concept of "ground truth" established by human experts in the context of diagnostic interpretation for its performance testing. The "ground truth" for its performance is derived from established engineering and materials science standards (ASTM, ISO, etc.).
4. Adjudication Method for the Test Set
- Not applicable. The performance tests are objective measurements against engineering standards, not subjective interpretations requiring adjudication.
5. 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
- Not applicable. This is a medical implant, not an AI diagnostic or decision support tool. No human reader studies with or without AI assistance were conducted or are relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a medical implant. The "algorithm" in this context refers to the manufacturing process driven by patient CT data and physician input for design, not an AI algorithm for diagnosis or interpretation. The device itself is "standalone" in that it performs its mechanical function once implanted, but its pre-market testing does not involve "algorithm-only performance" as would be understood for an AI/ML product.
7. The Type of Ground Truth Used
- Engineering Standards and Specifications: The "ground truth" for this device's performance is derived from compliance with established international standards for medical devices and materials, specifically:
- ASTM F382 (Standard Specification for Metallic Bone Plates) for mechanical performance.
- ISO 17665-1:2006 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) for sterilization.
- ISO 10993 (Biological evaluation of medical devices) for biocompatibility.
- For the patient-specific design process, the "ground truth" for dimensional fit is a virtual fitting against a 3D model of the patient's anatomy derived from a CT scan.
8. The Sample Size for the Training Set
- Although the device design is patient-specific and involves a "virtual planning" phase, this is not an AI/ML product that learns from a "training set" in the conventional sense. Each device is unique to a patient based on their CT scan. The "training" for the manufacturing process (both traditional and additive) happens through engineering validation and quality control procedures, not through a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no traditional "training set" for an AI/ML algorithm. The "ground truth" for the device's manufacturing and material properties is established through adherence to design specifications, material standards (ASTM F67, ASTM F136), and manufacturing quality control processes. The patient's CT scan provides the anatomical data for each individual device's design.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2017
KLS Martin LP Gary Moore Quality Management And Regulatory Affairs Manager 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246
Re: K163579
Trade/Device Name: KLS Martin Individual Patient Solutions Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 20, 2017 Received: October 23, 2017
Dear Gary Moore:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
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) K163579
Device Name
KLS Martin Individual Patient Solutions
Indications for Use (Describe)
KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
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Image /page/3/Picture/1 description: The image shows the logo for KLS Martin L.P., a company located in Jacksonville, FL. The logo is in red and gray, with the letters "KLS" in red and "martin" in gray. The company's address is 11201 Saint Johns Industrial Pkwy S, Jacksonville, FL 32246. The phone number is 904-641-7746, the toll-free number is 800-625-1557, and the fax number is 904-641-7378. The website address is www.klsmartinnorthamerica.com.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com
Section 5
510(k) Summary 21 CFR 807.92
| Submitter: | KLS Martin LP11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246 |
|---|---|
| Contact Person: | Gary MooreQuality Management and Regulatory Affairs ManagerPhone: 800-625-1557Email: gmoore@klsmartin.com |
| Date Prepared: | November 20, 2017 |
| Trade Name: | KLS Martin Individual Patient Solutions |
| Common Name: | Plate, Bone |
| Classification Name: | Bone plate (21 CFR 872.4760) |
| Regulatory Class: | II |
| Product Code: | JEY |
| Predicate Device: | KLS Martin Mandibular Reconstruction System II (K032442) |
| Reference Devices: | Patient Contoured Mesh (K062570)KLS Mini Osteosynthesis System (K943347)Centre-Drive Drill-Free Screw (K971297)KLS Martin Thoracic Plating System (K153482) |
| Device Description: | KLS Martin Individual Patient Solutions is comprised ofpatient-specific models and metallic bone plates used inconjunction with metallic bone screws for internal fixation ofmandibular bone. The devices are manufactured based onmedical imaging (CT scan) of the patient's anatomy withinput from the physician during virtual planning and prior tofinalization and production of the device. The physician onlyprovides input for model manipulation and interactivefeedback by viewing digital models of planned outputs thatare modified by trained KLS Martin engineers during theplanning session. For each design iteration, verification isperformed by virtually fitting the generated device modelover a 3D model of the patient's anatomy to ensure itsdimensional properties allow an adequate fit. |
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Image /page/4/Picture/1 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while "martin" is in gray, and "L.P." is in black. The font is sans-serif and modern.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Implants are provided non-sterile, range in thickness from 1.0 - 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.
- KLS Martin Individual Patient Solutions implant devices are Indications for Use: intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
Technological Characteristics & Substantial Equivalence Discussion
The intended use and technological characteristics of the subject device, KLS Martin Individual Patient Solutions, are either identical or have been demonstrated to be substantially equivalent to the primary predicate device, KLS Martin Mandibular Reconstruction System II (K032442):
The subject and primary predicate devices are intended for reconstructive surgery in the facial skeleton and share the same fundamental principle of operation - metallic plates used in conjunction with metallic screws for mandibular reconstructive surgery. The subject device of this submission is specific for mandibular fractures and reconstruction, which is identical to the predicate device (K032442), and similar to the reference device (K062570) cleared for use in the maxillofacial, mandibular, and craniofacial skeleton. Additional reference devices (K943347, K971297, and K153482) intended for bone fixation have been included to cover the range of screw characteristics described in this submission.
The design and materials used for the mandibular reconstruction plates in the subject device is similar to those cleared in KLS Martin Mandibular Reconstruction System II (K032442). The design and dimensions of the plates will be based on the patient-specific data, using similar methods described in Patient Contoured Mesh (K062570), made from either CP Titanium (ASTM F67) using traditional manufacturing methods or Ti-6Al-4V powder (ASTM F136) via additive, laser sintering manufacturing methods, and fall within previously cleared specifications for plate thicknesses ranging from 1.0 - 3.0 mm.
Plates will be fixated with previously cleared KLS Martin titanium screws ranging in diameter from 2.0 - 3.2 mm in lengths from 5 - 22 mm (K943347, K971297, K032442, and K153482). The screw characteristics (head style, type, range of size) have been cleared in the reference devices.
All devices are provided non-sterile for steam sterilization by the end-user.
The angles and dimensions of each KLS Martin Individual Implant Solutions implant devices is determined based on the patient anatomy and surgical plan and should not be further contoured intraoperatively, whereas the plates in the KLS Martin Mandibular Reconstruction System II (K032442) are angled and transversely pre-curved to follow the natural curves of the mandible, but are not designed based on patient specific data as described in the reference device K062570.
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K163579 Page 3 of 6
KUS ITOCIO CIT CII LEIT LE PE 1100 Satustial Play S - Jacksoville, FL 3220
12-11-737
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com
| Device Comparison Table | ||||||
|---|---|---|---|---|---|---|
| Individual PatientSolutions | KLS MartinMandibularReconstructionSystem IIK032442 | Patient ContouredMeshK062570 | KLS MiniOsteosynthesisSystemK943347 | Centre-DriveDrill-Free ScrewK971297 | KLS Martin ThoracicPlating SystemK153482 | |
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | (Reference Device) | |
| Indications for Use | KLS Martin IndividualPatient Solutionsimplant devices areintended for use in thestabilization andfixation of mandibularfractures andmandibularreconstruction. | The KLS MartinMandibularReconstruction SystemII is intended for use inthe stabilization andfixation of mandibularfractures andmandibularreconstruction. | Patient Contoured Mesh(PCM) is intended toreplace bony voids inmandibular,maxillofacial, orcraniofacial skeleton. | The device system hasthe same intended useas its predicate(K854886). | KLS MartinCentre-Drive Drill-FreeScrews are intended foruse in rigid internalfixationof the oral-maxillo-cranid-facial bones. Thebone screws are used toanchor plateswhich are contoured tofit the bony surface andstabilize the bonefragments. Theaddition of the selfdrilling feature is theonly difference betweenthe submitted deviceand the predicate devicereferenced. | The KLS MartinThoracic PlatingSystem is indicated foruse in the stabilizationand fixation offractures in the chestwall including sternalreconstructive surgicalprocedures, trauma, orplanned osteotomies. |
| Patient-specificconfiguration? | Yes. Devices aremanufactured | No. Devices areprovided in a standard | Yes. Devices aremanufactured | No. Devices areprovided in a standard | No. Devices areprovided in a standard | No. Devices areprovided in a standard |
| patient-specific, basedon a CT scan of thepatient. | shape and matched tothe patient's anatomyintraoperatively. | patient-specific, based ona CT scan of the patient. | shape and matched tothe patient's anatomyintraoperatively. | shape and matched tothe patient's anatomyintraoperatively. | shape and matched tothe patient's anatomyintraoperatively. | |
| Classification | 21 CFR 872.4760.Class II | 21 CFR 872.4760.Class II | 21 CFR 882.5330,Class II | 21 CFR 872.4760.Class II | 21 CFR 888.3030.Class II | 21 CFR 888.3030.Class II |
| Device Comparison Table | ||||||
| Individual PatientSolutions | KLS MartinMandibularReconstructionSystem IIK032442 | Patient ContouredMeshK062570 | KLS MiniOsteosynthesisSystemK943347 | Centre-DriveDrill-Free ScrewK971297 | KLS Martin ThoracicPlating SystemK153482 | |
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | (Reference Device) | |
| Product Code | JEY | MQN | GXN | JEY | HRS | HRS |
| Material | CP Titanium orTi-6A1-4V | CP Titanium orTi-6Al-4V | CP Titanium orTi-6A1-4V | Plates: CP TitaniumScrews: Ti-6A1-4V | Ti-6Al-4V | CP Titanium andTi-6Al-4V |
| ManufacturingMethod | Traditional(Subtractive)3D (Additive) | Traditional(Subtractive) | Traditional (Subtractive)3D (Additive - SkullModels) | Traditional(Subtractive) | Traditional(Subtractive) | Traditional(Subtractive) |
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) orSterile (gammairradiation) |
| Anatomical Sites | Mandible | Mandible | Craniofacial,Maxillofacial,Mandibular | Craniofacial,Maxillofacial,Mandibular | Craniofacial,Maxillofacial,Mandibular | Thoracic |
| Plates | ||||||
| Thickness | 1.0 mm - 3.0 mm | 1.0 mm - 3.0 mm | 0.6 mm - 1.0 mm | 0.6 - 1.0 mm | Not applicable | 1.0 mm - 3.0 mm |
| Style | Non-compressionCompressionThreaded | Non-compressionCompressionThreaded | Mesh and solid with orwithout holes | StandardLow Profile | Not applicable | Sternal: Standard linearshapes (locking)Rib: Bi-linear,pre-contoured X-&Z-shaped (locking) |
| Width(screw-holedependent) | Min: 7 mmMax: 8.5 mm | Min: 6 mmMax: 8 mm | Not applicable | Not applicable | Not applicable | Not applicable |
| Device Comparison Table | ||||||
| Individual PatientSolutions | KLS MartinMandibularReconstructionSystem IIK032442 | Patient ContouredMeshK062570 | KLS MiniOsteosynthesisSystemK943347 | Centre-DriveDrill-Free ScrewK971297 | KLS Martin ThoracicPlating SystemK153482 | |
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | (Reference Device) | |
| Length | Min: 31 mmMax: 320 mm | Min: 28.5 mmMax: 240.65 mm | Not applicable | Not applicable | Not applicable | Not applicable |
| Degree of curvature(in-plane) | Min: 90°Max: 180° | Min: 125°Max: 180° | Not applicable | Not applicable | Not applicable | Not applicable |
| Degree of curvature(out-of- plane) | Min: 60°Max: 180° | Min: N/AMax: 180° | Not applicable | Not applicable | Not applicable | Not applicable |
| Hole spacing | Greater than or equal to8 mm | 8 mm | Not applicable | Not applicable | Not applicable | Not applicable |
| Number of Holes | Min: 4Max: Dependent onlength & hole spacing | Min: 4Max: 27 | Not applicable | Not applicable | Not applicable | Not applicable |
| Screw Diameter | 2.0 mm - 3.2 mm | 2.0 mm - 3.2 mm | 1.5 mm | 1.5 mm - 2.3 mm | 1.0 mm - 2.0 mm | 2.3 mm - 3.2 mm |
| Screw Length | 5 mm - 22 mm | 8 mm - 22 mm | 3.5 mm - 15 mm | 4 mm - 19 mm | 2 mm - 7 mm | 7 mm - 17 mm |
| Screw Style | maxDrive & crossDrive(Drill-Free, locking[ThreadLock TaperScrew -TLTS],standard) | Drill-Free, locking(ThreadLock TaperScrew -TLTS) | standard, Drill-Free | crossDrive (slotted,standard, low profile)Centre-Drive(standard) | Centre-Drive, Drill-Free (standard) | maxDrive, Drill-Freescrew (locking,standard) |
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K163579 Page 4 of 6
KUS ITOCICCIIN LINE 11201 Saint Iohns Industrial Play S - Jacksonille, FL 3220
11-61-737
11201 Saint Johns Industrial Pkwy S ● Jacksonville, FL 32246 www.k1smartinnorthamerica.com
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K163579 Page 5 of 6
KUS MOCIC CIM CHIN LINE PHONE: 00461-1714 6 800-62-1537 Fax: 904-61-737
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com
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Image /page/8/Picture/1 description: The image shows the logo for KLS Martin L.P. The logo is composed of the text "KLS martin L.P.", with "KLS" in red, "martin" in gray, and "L.P." in black. The font is sans-serif and bolded.
11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
Performance Testing - Non-clinical
Bench testing was used to demonstrate that any differences between the subject and predicate devices do not raise any new safety and effectiveness questions. Mechanical testing was conducted in accordance with ASTM F382 to compare the bending properties of the additive manufactured subject plates against the previously cleared subtractive manufactured predicate plates. The bending resistance and fatigue life of the subject devices was determined to be equivalent or better than the predicate devices.
Steam sterilization validation was performed 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.
Biocompatibility endpoints were evaluated in accordance with ISO 10993. The battery of cytotoxicity, chemical analysis, sensitization and irritation, and chemical/material characterization testing conducted on the subject device were within the pre-defined acceptance criteria, and therefore, adequately addresses biocompatibility for implants with a permanent duration of contact.
Performance Testing - Clinical
Clinical testing was not necessary for the substantial equivalence determination.
Substantial Equivalence Conclusion:
The proposed device has the same intended used as the predicate devices. The performance testing included in the submission demonstrates that the differences in technological characteristics do not raise any new safety and effectiveness questions. The information submitted supports substantial equivalence.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.