(162 days)
The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function.
The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function. The SimPlant Immediate Smile System enables a predictable dental implant restoration procedure according to case planning done by the clinician.
The SimPlant Immediate Smile System enables a provisional prosthesis to be produced prior to and attached in the same session as implant installation.
The SimPlant Immediate Smile System includes SimPlant software that provides a method of importing medical imaging information from radiological imaging systems such as a 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. SimPlant enables the clinician to plan the dental implant positions including orientations pre-operatively in a virtual, 3D environment. The case planning can be used to produce patient specific SurgiGuide guides, thus transferring the virtual case planning into physical tools enabling the intra-operative preparation of the implant sites for the installation of implants in accordance to the virtual case planning.
The SimPlant Immediate Smile System is based upon knowledge of the locations and orientations of the implants prior to surgery. This knowledge enables the production of a SurgiGuide surgical guide. Aided by the SurgiGuide surgical guide, the implant sites can be prepared and the dental implants placed in the predetermined locations, enabling the immediate installation of the custom-made prefabricated provisional Immediate Smile bridge.
The SimPlant Immediate Smile System is a medical device intended for use in treatment planning and placement of dental implants. The device includes SimPlant software for image processing and pre-operative planning, and enables the production of patient-specific SurgiGuide surgical guides and prefabricated provisional Immediate Smile bridges.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Immediate Smile bridge component) | |
| Minimal dimension of cylindrical connections to withstand maximal load without fracture of the bridge | Determined based on maximal load. (Specific value not provided, but deemed acceptable) |
| Predicted micro-movement of implants upon loading of the immediate smile bridge with bite load (400 N on bridges without distal extension) | Shown to be acceptable. (Specific value not provided, but deemed acceptable) |
| Cement bonding strength (pull-out testing of cylindrical abutments) | Average maximal tensile force: 232 NMinimal measured tensile force: 190 N |
| Threshold for cement bonding strength | 150 N |
| Clinical Performance (Usability, Aesthetic Result, Material Properties) | |
| Usability of the System | Predefined acceptance thresholds were met. |
| Aesthetic result of the System | Predefined acceptance thresholds were met. |
| Adequacy of material properties of system components | Predefined acceptance thresholds were met. |
| System safety and effectiveness | Predefined acceptance thresholds were met for all criteria. |
2. Sample Sizes and Data Provenance
- Test Set (Clinical Evaluation):
- Sample Size: 20 patients
- Data Provenance: Clinical setting, "different countries" (retrospective or prospective not specified, but the phrase "Case follow-up was done after 12 weeks" suggests it was a prospective study).
- Test Set (Bench Top Testing / Engineering Tests):
- Specific sample sizes for individual bench tests (e.g., number of bridges for fracture, number of abutments for pull-out) are not provided, only the general statement that "Several Engineering tests and evaluations were undertaken."
- Training Set: Not explicitly mentioned in the provided text. The software validation refers to testing against "specifications," but a distinct "training set" for an AI/algorithm is not discussed in the context of this device. This suggests the device is likely rule-based or uses traditional image processing, rather than a machine learning model that requires a labeled training set in the modern sense.
3. Number of Experts and Qualifications for Ground Truth
- Clinical Evaluation: 11 doctors from different countries. Their specific qualifications (e.g., experience level, specialization beyond "doctor") are not detailed.
- Bench Top Testing / Engineering Tests: Not applicable, as ground truth for these tests is based on physical measurements and engineering specifications, not expert interpretation.
- Software Validation: "The software is validated together with end-users." The number and qualifications of these "end-users" are not specified.
4. Adjudication Method for the Test Set
- Clinical Evaluation: The text states, "Clinical feedback was gathered for all cases relative to the usability, aesthetic result and adequacy of the material properties of the system components. Predefined acceptance thresholds were met for all criteria indicative for the system safety and effectiveness." This implies that the feedback from the 11 doctors was aggregated and compared against predefined thresholds. There's no mention of a formal adjudication method (like 2+1 or 3+1 consensus) for individual cases or disagreements among the doctors.
- Bench Top Testing / Software Validation: Not applicable, as these tests rely on objective measurements and predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study to measure the effect size of human readers improving with AI vs. without AI assistance was not reported. The study focused on the clinical evaluation of the system (including the software and physical components) by doctors in a clinical setting, rather than comparing human reader performance with and without the AI component. The device is for treatment planning and guide fabrication, not for diagnostic interpretation by human readers.
6. Standalone Performance Study
- Yes, a standalone performance assessment of the algorithm/software (without direct human-in-the-loop performance measurement) was conducted through "Software Validation" and "bench top performance testing."
- Software Validation: "The software is thoroughly tested in accordance with documented test plans and in accordance to internal software development and testing procedures. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users."
- Bench Top Performance Testing: This included evaluations of the connection dimensions, predicted micro-movement, and cement bonding, which are standalone assessments of the physical components designed or influenced by the software.
7. Type of Ground Truth Used
- Clinical Evaluation: Clinical feedback from 11 doctors and follow-up data (after 12 weeks) served as the primary ground truth for usability, aesthetic results, material adequacy, and overall safety and effectiveness. This is a form of expert assessment/outcomes data.
- Bench Top Testing / Engineering Tests: Ground truth was based on engineering specifications, physical measurements, and predictive models (e.g., for micro-movement).
- Software Validation: Ground truth was based on predefined specifications for software functionality and controls.
8. Sample Size for the Training Set
- Not explicitly mentioned. The nature of the device (treatment planning software and physical guides) suggests it might not rely on a machine learning model that typically uses a "training set" in the same way as, for example, an image classification AI. The software is described as using "medical imaging information" to derive "visual representations of the imaged anatomical structures," implying a more traditional computational geometry and image processing approach.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as a distinct training set and its associated ground truth establishment method are not described for this device. The software's functionality is validated against specifications that presumably stem from anatomical knowledge and clinical requirements.
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510(k) Premarket Notification -SimPlant® Immedia
510(k) Summary
MAY 3 0 2012
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 LierdeQARA Management RepresentativeMaterialise Dental NVTechnologielaan 15LeuvenBelgiumTel. +32 16 39 6620Fax. +32 16 39 66 22Email: Carl.VanLierde@materialise.be |
| Date Prepared: | November 29, 2011 |
| Trade/ProprietaryName: | SimPlant Immediate Smile System |
| Common/UsualName: | System, Image processing. The product uses images acquired from ComputerizedTomography (CT) scanners |
| ClassificationName/ FDAReviewingBranch: | Picture Archiving and Communication system |
| DeviceClassification/Code: | Class II - 21 CFR §892.2050 LLZ |
| Predicate DeviceManufacturer: | SimPlant® 2011; (K110300)Nobel Biocare Guided Surgery Concept; (K050393)Ivoclar Vivadent - Telio CAD (K093708) |
| Purpose of the510(k) notice: | The reason for this 510k submission is to request clearance for a device that has beenreferred to herein as SimPlant Immediate Smile System (Image processing system)referenced under 21 CFR §892.2050 and considered a Class II device. |
| DeviceDescription: | The SimPlant Immediate Smile System is intended for use in treatment planning andplacement of dental implants, in order to restore masticatory function. The SimPlantImmediate Smile System enables a predictable dental implant restoration procedureaccording to case planning done by the clinician.The SimPlant Immediate Smile System enables a provisional prosthesis to beproduced prior to and attached in the same session as implant installation.The SimPlant Immediate Smile System includes SimPlant software that provides amethod of importing medical imaging information from radiological imaging systemssuch as a Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to acomputer file that is usable in conjunction with other diagnostic tools and expertclinical judgment. Visual representations of the imaged anatomical structures (e.g. thejaw) are derived, allowing for a three-dimensional assessment of the patient withoutpatient contact. SimPlant enables the clinician to plan the dental implant positionsincluding orientations pre-operatively in a virtual, 3D environment. The case planningcan be used to produce patient specific SurgiGuide guides, thus transferring the virtualcase planning into physical tools enabling the intra-operative preparation of the implantsites for the installation of implants in accordance to the virtual case planning.The SimPlant Immediate Smile System is based upon knowledge of the locations andorientations of the implants prior to surgery. This knowledge enables the production ofa SurgiGuide surgical guide. Aided by the SurgiGuide surgical guide, the implant sitescan be prepared and the dental implants placed in the predetermined locations, enablingthe immediate installation of the custom-made prefabricated provisional ImmediateSmile bridge. |
| Indications forUse: | The SimPlant Immediate Smile System is intended for use in treatment planning andplacement of dental implants, in order to restore masticatory function. |
| TechnologicalCharacteristics : | The predicate devices, SimPlant® 2011, Nobel Biocare Guided Surgery Concept andIvoclar - Telio CAD have a number of very similar and equivalent design/technological characteristics, which are very similar and equivalent with the SimPlantImmediate Smile System (see Substantial Equivalence comparison table in Section 14). |
| Performance.Data: | Software Validation in addition to bench top performance testing was conducted toensure the compatibility of all system components. |
| Clinical Data: | The SimPlant® Immediate Smile System was evaluated in a clinical setting by 11doctors from different countries. The System was evaluated with 20 patients. 6different implant brands were used during the evaluation. Case follow-up was doneafter 12 weeks.Clinical feedback was gathered for all cases relative to the usability, aesthetic resultand adequacy of the material properties of the system components. Predefinedacceptance thresholds were met for all criteria indicative for the system safety andeffectiveness. The immediate smile bridge component of the System can be used as atemporary restoration for immediate loading up to 12 weeks.The results of the clinical validation confirmed safety and effectiveness of the System. |
| Non clinicaltesting | Several Engineering tests and evaluations were undertaken to demonstrate theconformity of the system:The software is thoroughly tested in accordance with documented test plans and in accordance to internal software development and testing procedures. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users. The subsequent testing to validate the mitigations was documented in software test reports. The minimal dimension of the cylindrical connections of the immediate smile bridge where determined based on the maximal load that should be withstood without risk of fracture of the bridge. In order to evaluation the potential micro-movement of the implants upon loading of the immediate smile bridge component a predictive (mass-spring/ finite element) model was used. Micro-movement is a risk factor for implant failure. With bite load (point load) of 400 N on bridges without distal extension, predicted movements were shown to be acceptable. Evaluation of cement bonding was conducted via pull-out testing of cylindrical abutments fixed by means of the standard composite into a cylindrical hole corresponding in dimensions with the cylinders incorporated in the design of the provisional restoration. With a average maximal tensile force of 232N and a minimal measured tensile force of 190 N, the threshold of 150 N was exceeded. |
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| Based on the performance data the SimPlant Immediate Smile System wasdemonstrated to be safe and effective, testing all pre-set criteria on component andSystem levels. | |||
|---|---|---|---|
| PerformanceStandards: | DICOM NEMA PS 3.1-3.18: Digital imaging and communication in medicine: 2009ISO14971: Applications of risk management to medical devices: 2007ISO 13485: Medical devices Quality Management System: 2003ISO10993: Biological evaluations of medical devices: 1992 | ||
| TechnologicalCharacteristics: | Materialise Dental NV's SimPlant Immediate Smile System included in thissubmission uses the same fundamental scientific technology as the previously clearedSimPlant® 2011; (K110300). | ||
| Device for premarket notification | K110300 | ||
| Material | Trade name | SimPlant® Immediate Smile System | SimPlant® 2011 |
| Software - Magnetic mediaHardware -acrylic guides - biocompatible material stainless steel tubes/sleeves - medical grade PMMA provisional bridges - biocompatible | Software - Magnetic media |
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510(k) Premarket Notification -SimPlant® Immediate Sm
| Design | Software for use in pre-operative planning.The SimPlant Immediate Smile System includesSimPlant ® software, which provides a means forthe clinician for image segmentation and advancedpre-operative planning. This enables the clinician toview three-dimensional CT-scan data as well as toplan the case in a virtual three-dimensionalenvironment.This case planning can be used to produce aSurgical Template, thus transferring the virtual caseplanning into physical tools enabling the surgicalinstallation according to the virtual case planning.The SimPlant Immediate Smile System is basedupon knowledge of the location and orientation ofthe implant(s) prior to the surgery. This knowledgeenables the production of a SurgiGuide.Aided by the SurgiGuide, the sites can be preparedand the implants placed in the predeterminedlocations enabling the immediate attachment of theprefabricated temporary prosthesis, i.e. theImmediate Smile bridge structure or finalprosthesis. | Software for use in pre-operativeplanning.SimPlant ® software provides ameans for image segmentationand advanced pre-operativeplanning. Surgical templates maybe fabricated based on the outputof the pre-operative planning. |
|---|---|---|
| Function | The SimPlant® software component is used toincorporate the images from either an MRI or CTscan of the affected joint into the specializedplanning software.The SimPlant® software is used by a qualifiedsurgeon to plan, inspect, fine-tune and approve thepre-surgical plan. The software is used pre-operatively.SimPlant® software contains a library of dentalimplants, and additional instruments for theplacement of implants.A SurgiGuide® guide and/or Immediate SmileProvisional bridge structures may be designed andfabricated based on the output of the pre-operativeplanning.SurgiGuide® guides are patient specific templatesthat are intended to transfer the pre-operativelydetermined positioning of the dental implants tothe patient intra-operatively, assisting the surgeonin placing dental implants by guiding and markingdrill locations.The Immediate Smile bridge structure is a patientspecific temporary restoration, for partially or fullyedentulous cases either in lower or upper jaw, to beused immediately after implant placement and thisfor a short term, i.e. maximally 16 weeks. | SimPlant® software is used toincorporate the images from eitheran MRI or CT scan of the affectedjoint into the specialized planningsoftware.The SimPlant® software is used bya qualified surgeon to plan,inspect, fine-tune and approve thepre-surgical plan. The software isused pre-operatively.SimPlant® software contains alibrary of dental implants, andadditional instruments for theplacement of implants.A SurgiGuide® guide may bedesigned and fabricated based onthe output of the pre-operativeplanning. |
| Programminglanguage | C++ | C++ |
| Operatingsystem | Windows | Windows |
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510(k) Premarket Notification -SimPlant® Immediate Smile System
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K113739
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510(k) Premarket Notification --SimPlant* Immediate Smile System
| Device for premarket notification | K093708 | ||
|---|---|---|---|
| SimPlant® Immediate Smile Bridge resin | Ivoclar - Telio CAD | ||
| Tradename | |||
| MaterialChemicalCharacteri-sitics | 100 % PMMA (Polymethylmethacrylat) | 99.5 % Polymethylmethacrylate(CAS-No. 9011-14-7), Pigments | |
| MechanicalCharacterisitics | Flexural strength 97 MPaHardness145 MPa Water absorption1,1 µg/mm³ | Flexural strength 130 MPaHardness 180 MPaWater absorption < 28 µg/mm³Solubility in water < 0.6 µg/mm³ | |
| Biocompatibility | Biocompatibility of the dental prosthesismaterial were performed according to theinternational standards ISO 10.993-1992"Biological evaluation of medical devices" (ISO10993-1, ISO 10993-5, ISO-DIS 10993-10) andDIN-V 13 930-1990 "Biological test of dentalmaterials".The resin did not have any cell toxic potentialThe resin did not cause any irritation of theskin or any allergic sensitisation. | Test specimens made of Telio CADwere subjected to cytotoxicity andmutagenicity tests. The results ofboth tests show that Telio CAD isneither cytotoxic nor mutagenicand that its use does not pose atoxicological risk if used asindicated in the respectiveinstructions for use. | |
| Storage | To be stored in the original packaging, in a dryenvironment (< 25 °C), away from directsunlight. Shelf life 4 years. | No specific requirements.Store at 2-28 °C / 36-82 °F | |
| Wear period | Up to 6 months. (i.e. longer thanrecommended life of the SimPlant ImmediateSmile bridge) | 12 months | |
| Conclusion: | SimPlant Immediate Smile System and its predicate devices, SimPlant® 2011(K110300), the Nobel Biocare Guided Surgery Concept (K050393) and Ivoclar TelioCAD, have the same technological characteristics and principles of operation.The SimPlant Immediate Smile System can be used with SurgiGuide® guides and / orwith provisional Immediate Smile bridges.SurgiGuide® guides are patient specific templates used intra-operatively to prepare theosteotomy for placement of dental implants, manufactured as pre-operativelydetermined in the software. SurgiGuide guides for upper and/or lower jaw are designedand manufactured using rapid prototyping (stereolithography), based on the approved |
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| structures, used immediately after implant placement and manufactured in accordance to the pre-operatively determined implant plan in the software. | |
|---|---|
| The differences noted above do not present new issues of safety or effectiveness for the SimPlant® Immediate Smile System. |
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Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus. The symbol is composed of three curved lines that converge at the bottom.
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 QARA Management Representative Materialise Dental NV Technologielaan 15 B-3001 LEUVEN BELGIUM
MAY 3 0 2012
Re: K113739
Trade/Device Name: SimPlant® Immediate Smile System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, DZE, and EBG Dated: May 25, 2012 Received: May 29, 2012
Dear Mr. 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 general controls provisions 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 additional controls. Existing major 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 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 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the up your device as described in your Section 510(k) premarket notification. The FDA finding of substantial 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 809), please contact 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 Division 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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510(k) Premarket Notification -SimPlant® Immediate Smile System
Indications for Use
.510(k) Number (if known): K113739
Device Name: SimPlant® Immediate Smile System
Indications for Use:
The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function.
Prescription Use _
elok
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart C)
14
Over-The-Counter Use _
(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
§ 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).