(161 days)
SimPlant Navigator Personalized Dental Care System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre-operatively determined in the software.
SimPlant Navigator Personalized Dental Care System provides a method of importing medical imaging information from radiological imaging systems such as Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer file that is usable in conjunction with other diagnostic tools and expert clinical judgment. Visual representations of the imaged anatomical structures (e.g. the jaw) are derived allowing for a three-dimensional assessment of the patient without patient contact. Dental implant positions including orientations are planned pre-operatively. Computer visualization of the 3D anatomical jaw models, planned implants, planned tooth setup, and numerical measurements assist the surgeon in the creation and approval of a pre-surgical plan. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit are used intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre-operatively determined in the software.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
Note: The provided document is a 510(k) summary, which often focuses on establishing substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance against those criteria in a tabular format. The document highlights software and bench testing for compatibility, but not a standalone clinical performance study with defined metrics. Therefore, some sections below will indicate "Not explicitly stated" or will infer information based on the presented context.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not include a table of explicit acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantitative error bounds) and corresponding reported device performance values. The performance data section broadly mentions "Software Validation in addition to bench top performance testing was conducted to ensure the compatibility of all system components."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Software Validation" and "bench top performance testing" without detailing the specific datasets or number of cases used for these tests.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted?: No. The document does not mention any MRMC study comparing human reader performance with or without AI assistance.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was reported.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Conducted?: Yes, to a degree. The "Software Validation" and "bench top performance testing" could be interpreted as standalone performance evaluations of the software's functionality and compatibility. However, specific metrics of clinical performance (e.g., accuracy of implant placement prediction) were not provided from such a study. The focus is on ensuring the software correctly performs its intended functions (image segmentation, pre-operative planning, transfer of information).
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated for specific metrics. The software's function involves processing medical images (CT/MRI) for 3D reconstruction and pre-operative planning. The "acceptance testing" and "formal testing" likely validated the software's output against expected computational results or pre-defined clinical scenarios, but the source of the "ground truth" for these comparisons is not detailed. Given the nature of the device (planning software), ground truth would typically relate to the accuracy of anatomical visualization and the precise positioning of planned implants relative to a known anatomical model or expert-defined optimal plan.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is explicitly described as an "Image processing system" leveraging "Visual representations" and "numerical measurements" for pre-operative planning based on CT/MRI data. It's a software tool for clinicians to use, not a machine learning or AI-driven diagnostic algorithm that would typically require a training set in the conventional sense for learning patterns from data. The software's design is based on established imaging and anatomical principles, rather than being "trained" on a large dataset of patient cases to learn to identify patterns or make predictions.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this device does not appear to utilize a training set in the context of machine learning or AI. Its functionality is based on deterministic algorithms for image processing and 3D visualization.
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 892.2050.
| Submitter: | Materialise Dental NVTechnologielaan 15LeuvenBelgium |
|---|---|
| EstablishmentReg. Number: | 3006638827 |
| Contact: | Carl Van LierdeQA/RA ManagerMaterialise Dental NVTechnologielaan 15LeuvenBelgiumTel. +32 16 39 67 14Fax. +32 16 39 66 22Email: carl.vanlierde@materialise.be |
| Date Prepared: | September 12, 2011 |
| Trade/ProprietaryName: | SimPlant Navigator Personalized Dental Care System |
| Common/UsualName: | System, Image processing. The product uses images acquired from ComputerizedTomography (CT) scanners |
| ClassificationName/ FDAReviewingBranch: | Radiology branch |
| DeviceClassification/Code: | Class II - 21 CFR §892.2050 LLZ |
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| Predicate DeviceManufacturer: | SimPlant® 2011; (K110300)Nobel Biocare Guided Surgery Concept; (K050393) |
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| Purpose of theSPECIAL 510(k)notice: | The reason for this Special 510k submission is to request clearance for a modificatioto a device that has been cleared under the 510(k) process referred to herein aSimPlant Navigator Personalized Dental Care System (Image processing systemreferenced under 21 CFR §892.2050 and are considered Class II devices. |
| DeviceDescription: | SimPlant Navigator Personalized Dental Care System provides a method oimporting medical imaging information from radiological imaging systems such asComputer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer fithat is usable in conjunction with other diagnostic tools and expert clinical judgmenVisual representations of the imaged anatomical structures (e.g. the jaw) are deriveallowing for a three-dimensional assessment of the patient without patient contacDental implant positions including orientations are planned pre-operatively. Computevisualization of the 3D anatomical jaw models, planned implants, planned tooth setuand numerical measurements assist the surgeon in the creation and approval of a presurgical plan. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit are useintra-operatively to prepare the osteotomy for placement of BIOMET 3i implants preoperatively determined in the software. |
| IndicationsforUse: | SimPlant Navigator Personalized Dental Care System is intended for use as a softwarinterface and image segmentation system for the transfer of imaging information froma medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is alsintended as pre-planning software for dental implant placement and surgical treatment.SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intraoperatively to prepare the osteotomy for placement of BIOMET 3i implants preoperatively determined in the software. |
| TechnologicalCharacteristics: | The predicate devices, SimPlant® 2011 and Nobel Biocare Guided Surgery Concehave a number of very similar and equivalent design /technological characteristics:which are very similar and equivalent with the SimPlant Navigator Personalized DentCare System (see Substantial Equivalence comparison table in Section 14). |
| PerformanceData: | Software Validation in addition to bench top performance testing was conducted tensure the compatibility of all system components. |
| Clinical Data: | N/A |
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| PerformanceStandards: | a. DICOM NEMA PS3.1-3.18: Digital imaging and communication in medicine:2009b. ISO14971: Applications of risk management to medical devices: 2007c. ISO13485: Medical Devices Quality Management System: 2003d. ISO9001: Quality Management System: 2008e. ISO10993: Biological evaluations of medical devices: 1992 | Intended Use | |||||||||||||||||||
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| SubstantialEquivalence: | Materialise Dental NV's SimPlant Navigator Personalized Dental Care Systemincluded in this submission have the same intended use, fundamental scientifictechnology, similar indications, and principles of operation as the previously cleareSimPlant® 2011; (K110300).Refer to the following substantial equivalence data table: | The SimPlant NavigatorNavigator Personalized DentalCare System is intended foruse as a software interfaceand image segmentationsystem for the transfer ofimaging information from amedical scanner such as a CTscanner or a MagneticResonance scanner. It is alsointended as pre-planningsoftware for dental implantplacement and surgicaltreatment.The SimPlant NavigatorPersonalized Dental CareSystem can be used with thefollowing Biomet 3iinstrument kits and theirrespective components:implant mounts, corticalperforator, tissue punches,drill positioning handles, twistdrills, countersink drills,shaping drills, bone taps, boneprofilers, drivers, and ratchets. | Materialise Dental'sSimPlant® 2011 software isintended for use as asoftware interface andimage segmentation systemfor the transfer of imaginginformation from a medicalscanner such as a CT scanneror a Magnetic Resonancescanner. It is also intendedas pre-planning software fordental implant placementand surgical treatment. | The Guided SurgeryConcept and Teeth-in-an-Hour are indicatedfor the treatment ofsingle, partially andtotally edentulous jawsfor placement of implantfixtures with immediatefunction to restorepatient esthetics andchewing function. Thefollowing prerequisitesmust be fulfilled:- Adequate amount ofjaw bone- The quality of jaw bonemust be judged asadequate | |||||||||||||||||
| Device forpremarketnotification K110300 K050393 Tradename SimPlant® NavigatorPersonalized Dental CareSystem SimPlant® 2011 Nobel Biocare TheGuided Surgery Concept Commonname SimPlant® Software Classification Product Code: LLZ21 CFR. § 892.2050Classification Panel: RadiologyDevice Class: II Product code: LLZ21 CFR. § 892.2050Classification Panel:RadiologyDevice Class: II Product code: DZE21 CFR. § 872.3640Classification Panel:DentalDevice Class: II | SurgiGuide® guides areintended for single use only. | ||||||||||||||||||||
| Software – magnetic media | Software – Magnetic media | Software – Magneticmedia | |||||||||||||||||||
| Material | Hardware –polyamide guides –biocompatiblematerial stainless steeltubes/sleevesmedical grade | HardwarePolyamideguidesbiocompatiblematerial |
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Special 510(k) Premarket Notification -The SimPlant® Navigator Personalized Dental Care System
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Special S10(k) Premarket Notification – Page 5 – F
Special S10(k) Premarket Notification – The SimPlant® Navigator Personalized Dental Care System
| Software for use in pre-operative planning. | Software for use in pre-operative planning. | Software for use in pre-operative planning. | ||
|---|---|---|---|---|
| Design | The SimPlant NavigatorPersonalized Dental CareSystem includes SimPlant®software, which provides ameans for the clinician forimage segmentation andadvanced pre-operativeplanning. This enables theclinician to view three-dimensional CT-scan data aswell as to plan the case in avirtual three-dimensionalenvironment. | SimPlant® software providesa means for imagesegmentation and advancedpre-operative planning.Surgical templates may befabricated based on theoutput of the pre-operativeplanning. | The Guided SurgeryConcept includes a 3D-Planning Software thatenables the clinician toview three-dimensionalCT-scan data as well asto plan the case in avirtual three-dimensionalenvironment. | |
| The case planning can beused to produce a SurgicalTemplate, thus transferringthe virtual case planning intophysical tools enabling thesurgical installation accordingto the virtual case planning. | This case planning canbe used to produce aSurgical Template, thustransferring the virtualcase planning intophysical tools enablingthe surgical installationaccording to the virtualcase planning. | |||
| The SimPlant NavigatorPersonalized Dental CareSystem is based uponknowledge of the locationand orientation of theimplant(s) prior to thesurgery. This knowledgeenables the production of aSurgiGuide. | The Guided SurgeryConcept is based uponknowledge of thelocation and orientationof the implant(s) priorto the surgery. Thisknowledge enables theproduction of a SurgicalTemplate. | |||
| Aided by the SurgiGuide, thesites can be prepared and theimplants placed in thepredetermined locationsenabling the immediateattachment of theprefabricated temporary orfinal prosthesis. | Aided by the SurgicalTemplate, the sites canbe prepared and theimplants placed in thepredetermined locationsenabling the immediateattachment of theprefabricated temporaryor final prosthesis. | |||
| The SimPlant® softwarecomponent is used toincorporate the images fromeither an MRI or CT scan ofthe affected joint into thespecialized planningsoftware. | SimPlant® software is used toincorporate the images fromeither an MRI or CT scan ofthe affected joint into thespecialized planning software. | |||
| The SimPlant® software isused by a qualified surgeonto plan, inspect, fine-tuneand approve the pre-surgicalplan. The software is usedpre-operatively. | The SimPlant® software isused by a qualified surgeon toplan, inspect, fine-tune andapprove the pre-surgical plan.The software is used pre-operatively. | |||
| Function | SimPlant® software containsa library of dental implants,and additional instrumentsfor the placement ofimplants. | SimPlant® software containsa library of dental implants,and additional instruments forthe placement of implants. | ||
| A SurgiGuide® guide may bedesigned and fabricatedbased on the output of thepre-operative planning. | A SurgiGuide® guide may bedesigned and fabricatedbased on the output of thepre-operative planning. | |||
| SurgiGuide® guides arepatient specific templatesthat are intended to transferthe pre-operativelydetermined positioning ofthe dental implants to thepatient intra-operatively,assisting the surgeon inplacing dental implants byguiding and marking drilllocations. | ||||
| Programminglanguage | C++ | C++ | ||
| Operatingsystem | Windows | Windows | ||
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Special 510(k) Premarket Notification --The SimPlant® Navigator Personalized Dental Care System
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| Testing | Hardware testing:• Biocompatibilitytesting of patientcontactingcomponents• Sterilization testing• Sterilizationdimensionalstability test | |
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| Software testing:• Unit testing• Integration testing• IR testing• Smoke testing• Formal testing• Acceptance testing• Alpha testing• Beta testing | Software testing:• Unit testing• Integration testing• IR testing• Smoke testing• Formal testing• Acceptance testing• Alpha testing• Beta testing | |
| Conclusion: | SimPlant Navigator Personalized Dental Care System and its predicate device:SimPlant® 2011 (K110300) and the Nobel Biocare Guided Surgery Concep(K050393), have the same intended use, indications for use, similar technologicacharacteristics, and principles of operation.SurgiGuide® guides and the BIOMET 3i Navigator® Surgical Kit, which are used intraoperatively to prepare the osteotomy for placement of BIOMET 3i implants preoperatively determined in the software.By modifying the SimPlant® 2011 to include the SurgiGuide® and Navigation SurgicaKit does not raise any new questions of safety or effectiveness. | |
| The differences noted above do not present new issues of safety or effectiveness for thSimPlant® Navigator Personalized Dental Care System. |
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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Carl Van Lierde QA/RA Manager Materialise Dental NV Technologielaan 15 3001 LEUVEN BELGIUM
FEB 2 2 2012
Re: K112679
Trade/Device Name: SimPlant® Personalized Dental Care System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, NOF, NDP, and DZA Dated: January 10, 2012 Received: February 16, 2012
Dear Mr. Van Lierde:
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 r ou may, merelove, manel of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is elassified to regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r reads of ac now has a determination that your device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or uny 1 eather the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical do rece forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the quarty, adevice as described in your Section 510(k) premarket win anow you to begin marial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 You don't openite and the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Special 510(k) Premarket Notification --The SimPlant® Navigator Personalized Dental Care System
Indications for Use
510(k) Number (if known): K // Ze 79
Device Name: SimPlant® Personalized Dental Care System
Indications for Use:
SimPlant Navigator Personalized Dental Care System is intended for use as a software Simirralit Navigator Tersonation system for the transfer of imaging information from a medical meriate and mage segmentation by Magnetic Resonance scanner. It is also intended as prebearing software for dental implant placement and surgical treatment.
SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra-Surgioure guides and the Droming of BIOMET 31 implants pre-operatively determined in the software.
Prescription Use
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K. | K112679 |
|---|---|
| ------- | --------- |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).