(118 days)
Materialise Dental's SimPlant Go software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a pre-operative software program for simulating /evaluating dental implant placement and surgical treatment options.
SimPlant Go allows the individual patient's CT image to be assessed in a three-dimensional way, to see the anatomical structures without patient contact or surgical insult. It includes features for dental implant treatment simulation. Additional information about the exact geometry of the tooth surfaces can be visualized together with the CT data and periodontic procedures with dental implants can be simulated. The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment.
The provided text describes the 510(k) submission for SimPlant Go, a pre-operative software program for simulating and evaluating dental implant placement. The document focuses on demonstrating that SimPlant Go is substantially equivalent to a predicate device (SimPlant 2011; K110300) rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or error margins) for SimPlant Go. Instead, it describes various software validation and testing activities and concludes with a qualitative statement of equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Quantitative Performance Metrics (e.g., specific accuracy, error rates, etc.) | Not explicitly stated in quantitative terms. |
| Functional Equivalence to Predicate Device | "Compared to the predicate device SimPlant 2011, SimPlant Go yielded an identical output when using identical input data." This is the primary "performance" claim, asserting that its functionality produces the same results as the predicate under the same conditions. |
| Software Testing Completion | Unit testing, peer code reviewing, integration testing, IR testing, smoke testing, formal testing, acceptance testing, alpha testing, beta testing all completed. Results are on file at Materialise Dental. |
| Design Validation | Performed by an external usability company (Macadamian) through interviews and usability tests. "All validation criteria were met." |
| Beta Validation (Usability) | Performed with 28 external users and 5 internal users. "All validation criteria were met." |
| Clinical Case Planning Validation | Performed, and "All validation criteria were met." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For design validation by Macadamian: The text mentions "interviews and usability tests were performed" but does not specify the number of cases or data points used in these tests.
- For beta validation: "additional usability tests were performed with in total 28 external users and 5 internal users." This refers to the number of users, not necessarily the number of clinical cases or data sets they evaluated. The number of cases is not specified.
- For clinical case planning validation: The text states "Clinical case planning in SimPlant GO was validated" but does not specify the number of clinical cases used.
- Data Provenance: Not explicitly stated. The nature of the device (pre-operative planning software) suggests that the data would be medical images (CT scans). The country of origin and whether the data was retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the establishment of a "ground truth" for the test set in the traditional sense of expert consensus on image interpretation or pathology. The validation activities focus on software functionality and usability.
- Design validation involved an "external usability company i.e. Macadamian." Their qualifications are not detailed beyond being a "usability company."
- Beta validation involved "external users" and "internal users." Their qualifications are not specified, though the device is intended for "medically trained people."
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as the validation focuses on comparing the software's output to the predicate device and usability, rather than expert interpretation of medical findings against a "ground truth."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission primarily focuses on functional equivalence to a predicate device and usability, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The validation conducted appears to be a form of standalone testing in that the software's output was compared to the predicate device's output. The statement "Compared to the predicate device SimPlant 2011, SimPlant Go yielded an identical output when using identical input data" suggests an algorithm-only comparison for functional correctness. However, this is presented within the context of demonstrating substantial equivalence, not as a standalone performance study with specific metrics like sensitivity or specificity.
7. Type of Ground Truth Used
The primary "ground truth" for demonstrating performance is implicitly the output of the predicate device (SimPlant 2011) when subjected to identical input data. For usability testing, the 'ground truth' would be user feedback and whether "validation criteria were met" as determined by the usability studies. There is no mention of pathology, outcomes data, or consensus from clinical experts for specific diagnostic or planning accuracy.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or its sample size. This suggests that the device, being an updated version of existing planning software (SimPlant 2011), likely relies on well-established algorithms and logic rather than a machine learning model that requires a distinct training phase with a large labeled dataset. The testing focused on ensuring the new C# implementation produced identical results and maintained usability.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is not applicable or described in the provided text.
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K1204333 Page . I of . 6
5 2012 JUL
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 LierdeManagement Representative QARAMaterialise Dental NVTechnologielaan 15LeuvenBelgiumTel. +32 16 39 6620Fax. +32 16 39 66 22Email: Carl.VanLierde@materialise.be |
| Date Prepared: | January 31, 2012 |
| Trade/ProprietaryName: | SimPlant Go |
| Common/UsualName: | Materialise Dental's SimPlant Go software is indicated for use as a medical front-endsoftware that can be used by medically trained people for the purpose of visualizinggray value images. It is intended for use as a pre-operative software program forsimulating /evaluating dental implant placement and surgical treatment options. |
| ClassificationName/ FDAReviewingBranch: | Radiology branch |
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| Predicate DeviceManufacturer: | SimPlant® 2011; (K110300) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 Go referenced under 21 CFR §892.2050 and considereda Class II device. | |||||||||||
| DeviceDescription: | SimPlant Go allows the individual patient's CT image to be assessed in a three-dimensional way, to see the anatomical structures without patient contact or surgicalinsult. It includes features for dental implant treatment simulation. Additionalinformation about the exact geometry of the tooth surfaces can be visualized togetherwith the CT data and periodontic procedures with dental implants can be simulated.The output file is intended to be used in conjunction with diagnostic tools and expertclinical judgment. | |||||||||||
| Indications forUse: | Materialise Dental's SimPlant Go software is indicated for use as a medical front-endsoftware that can be used by medically trained people for the purpose of visualizinggray value images. It is intended for use as a pre-operative software program forsimulating /evaluating dental implant placement and surgical treatment options. | |||||||||||
| TechnologicalCharacteristics: | Materialise Dental NV's SimPlant Go included in this submission has the sametechnological characteristics as the previously cleared SimPlant® 2011; (K110300).Both software devices run on the Windows operating system. The main technologicaldifference between SimPlant Go and the predicate device is the fact that theprogramming language used is C# as opposed to C++.SimPlant Go and the predicate device SimPlant 2011 are manufactured by MaterialiseDental.Similarities and differences between predicate and subject device in terms offunctions: | |||||||||||
| Category Features Available (X) or not (0) Predicate Subject File open tools Open and save .Go projects X X |
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K120733 are 3 of 6
| Planning Tools | Selection, sizing and manipulating implantrepresentations for planning /simulating theirpositions and orientations relative toanatomical structures of interest | X | X |
|---|---|---|---|
| Communication tools: | Link to an online shop | X | X |
| File open tools | (CB)CT images import;Image selector | X | 0 |
| Visualization tools | 2D gray value images; Panoramic curve;Volume rendering | X | 0 |
| Segmentation tools: | SimPlant Go does not have segmentationtools (e.g. thresholding, region growing,dynamic region growing, manual editing,cavity filling, morphological orBooleanoperations) | X | 0 |
| Measurement tools: | Gray values around implants; Profile line;Image statistics | X | 0 |
| Preparation tools | Reorient axial images to occlusal plane;Nerve; Virtual teeth; Optical scan registration;Dual scan registration; Grafts and volumes | X | 0 |
| Planning Tools | Abutments; Fixation screws; Simulation ofdistraction / osteotomy; Occlusion tool | X | 0 |
| Evaluation tools: | Virtual occludator; Soft tissue simulation | X | 0 |
| Communication tools: | Distribute View; E-mail project; Upload forsupport; Save or print screenshot; Capturemovie; Export DICOM | X | 0 |
Performance
Software Validation in addition to bench top performance testing was conducted to
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| Data: | ensure the compatibility of all system components and to support the safety andeffectiveness of the device. In particular the following V&V activities were performed:Testing:The testing of the software consisted of unit testing, peer code reviewing, integrationtesting, IR testing, smoke testing, formal testing, acceptance testing, alpha testing, betatesting. The results of the complete testing are on file in the Materialise Dental officesand are contained within the Design History File.The results of the testing were:BUGS: differences between software and requirements. The project manager, ifnecessary after consulting with the application engineer or the acquirer of theproject, set the priorities for these bugs; the development manager or teamleader assigned a developer to fix the bug. SUGS: suggestions for improvements on the software. Design Review wasperformed to decide if these suggestions would be implemented. Validation:Several validation activities were performed:Design validation Beta validation by use of mockups, prototypes and internal validation Clinical Beta validation For SimPlant GO an extensive design validation was performed by an externalusability company i.e. Macadamian. Interviews and usability tests were performed.As part of the Beta validation additional usability tests were performed with in total 28external users and 5 internal users.Clinical case planning in SimPlant GO was validated. All validation criteria were met.Compared to the predicate device SimPlant 2011, SimPlant Go yielded an identicaloutput when using identical input data. |
|---|---|
| Clinical Data: | N/A |
| 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: 2003ISO 9001: Quality Management System: 2008 |
. . . . .
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Substantial Equivalence:
Materialise Dental NV's SimPlant Go included in this submission uses similar (K110300).
| Device comparison table | ||
|---|---|---|
| Device for premarket notification | K110300 | |
| Trade name | SimPlant® Go | SimPlant® 2011 |
| Common.name | SimPlant® Basic Software | SimPlant® Software |
| Classification | Product Code: LLZ21 CFR. § 892.2050 | Product code: LLZ21 CFR. § 892.2050 |
| Classification Panel: RadiologyDevice Class: II | Classification Panel: RadiologyDevice Class: II | |
| Intended Use | Materialise Dental's SimPlant Gosoftware is indicated for use as a medicalfront-end software that can be used bymedically trained people for the purposeof visualizing gray value images. It isintended for use as a pre-operativesoftware program for simulating/evaluating dental implant placementand surgical treatment options. | Materialise Dental's SimPlant®software is intended for use as asoftware interface and imagesegmentation system for the transferof imaging information from amedical scanner such as a CT scanneror a Magnetic Resonance scanner. Itis also intended as pre-planningsoftware for dental implantplacement and surgical treatment. |
| Material | Software - Magnetic media | Software - Magnetic media |
| Design | Software for use in pre-operativeplanning. | Software for use in pre-operativeplanning. |
| Materialise Dental's SimPlant Gosoftware is intended for use as asoftware interface for the transfer ofimaging information from a medicalscanner such as a CT (either conventionalmultislice or cone beam CT) scanner to acomputer file usable in conjunction withother diagnostic tools and expert clinicaljudgment. The software is intended to beused for simulating / evaluating dentalimplant placement and surgicaltreatment options, supporting a wide | SimPlant® software providesmeans for image segmentation andadvanced pre-operative planning.Surgical templates may be fabricatedbased on the output of the pre-operative planning. |
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| Function | The SimPlant® software component isused to incorporate the images fromeither an MRI or CT scan of the affectedjoint into the specialized planningsoftware.The SimPlant® software is used by aqualified surgeon to plan, inspect, fine-tune and approve the pre-surgical plan.The software is used pre-operatively.SimPlant® software contains a library ofdental implants, and additionalinstruments for the placement ofimplants. | 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 by aqualified surgeon to plan, inspect,fine-tune and approve the pre-surgical plan. The software is usedpre-operatively.SimPlant® software contains alibrary of dental implants, andadditional instruments for theplacement of implants. |
|---|---|---|
| Programminglanguage | C# | C++ |
| Operatingsystem | Windows | Windows |
| HardwareTesting | N/A | N/A |
| Softwaretesting | Unit testing Integration testing IR testing Smoke testing Formal testing Acceptance testing Alpha testing Beta testing | Unit testing Integration testing IR testing Smoke testing Formal testing Acceptance testing Alpha testing Beta testing |
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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 Management Representative QARA Materialise Dental NV Technologielaan 15 LEUVEN 3001 BELGIUM
5 2012 JUL
Re: K120733
Trade/Device Name: SimPlant® GO Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 25, 2012 Received: June 1, 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 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 will allow you to begin marketing 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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K120733
510(k) Premarket Notification -SimPlant® Go
Indications for Use
510(k) Number (if known): K 12 o + 3 3
Device Name: SimPlant® GO
Indications for Use:
Materialise Dental's SimPlant Go software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a pre-operative software program for simulating dental implant placement and surgical treatment options.
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)
Aranald D. O'Hern
Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
S10K 120733
§ 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).