(149 days)
SimPlant 2011 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.
SimPlant 2011 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 pro-planning software for dental implant placement and surgical treatment.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a medical device performance study. Instead, it details a 510(k) premarket notification for SimPlant 2011, focusing on demonstrating substantial equivalence to a predicate device (SimPlant Dr James, K053592).
This type of submission primarily relies on showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. As such, the "acceptance criteria" discussed are largely related to software validation and regulatory compliance, rather than specific clinical performance metrics.
However, based on the information provided, here's an attempt to answer your questions, interpreting "acceptance criteria" in the context of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Interpreted from 510(k)) | Reported Device Performance |
|---|---|
| General Compliance/Functionality:- Software functionality as described in its design.- Robustness to usual, unexpected, and invalid inputs.- Adherence to medical device software development lifecycle standards (e.g., ISO 13485:2003, IEC 62304:2006, EN ISO 14971:2007). | - The SimPlant 2011 software was thoroughly tested and originates from the same medical software platform as the cleared predicate (K033849).- Testing performed included Unit, Integration, IR, Smoke, Formal (General, Reference, Usage), Acceptance, Alpha, and Beta testing.- Both static (inspections, walkthroughs) and dynamic analysis were used to find and prevent problems and demonstrate run-time behavior.- "All controls and procedures are functioning properly" as per documented test plan derived from final specifications. Results are on file at Materialise Dental. |
| Substantial Equivalence:- Same intended use as the predicate device.- Similar technological characteristics to the predicate device.- Any differences in technological characteristics do not raise new questions of safety or effectiveness. | - Intended Use: Identified as "substantially equivalent" for use as a software interface and image segmentation system, and as pre-planning software for dental implant placement and surgical treatment. (Matches predicate's general intended use).- Technological Comparison: SimPlant 2011 has more features (e.g., ISO Surface, X-Ray Rendering, Segmentation Wizard, advanced virtual teeth, dual scan registration, optical scanner support, occlusion tool, virtual occludator) than the predicate, SimPlant System.- Conclusion: The submitter states, "considered to be substantially equivalent in design, material and function... It is believed to perform as well as the predicate device." FDA concurrence on substantial equivalence was granted. |
| Safety & Effectiveness:- Device does not contact the patient.- Device does not deliver medication or therapeutic treatment.- Application of risk management to devices. | - The product "does not contact the patient and does not deliver medication or therapeutic treatment."- Risk management was applied in accordance with EN ISO standard 14971:2007. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data or patient images for performance evaluation. The "tests" mentioned are primarily related to software engineering and validation (Unit testing, Integration testing, etc.) to ensure the software itself functions as designed. There is no mention of a specific dataset of patient images used to evaluate the clinical performance or accuracy of the segmentation or planning features in a statistically quantifiable manner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As noted above, there's no mention of a clinical "test set" requiring expert-established ground truth for performance evaluation. The validation described is focused on software quality and functionality.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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
No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) submission. The document focuses on demonstrating substantial equivalence of the software's functionality and safety, not on its impact on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "thorough testing" of the software, including various types of software testing (Unit, Integration, Formal, Acceptance, etc.). This would inherently involve evaluating the algorithm's standalone performance in terms of its intended software functions (e.g., segmentation, rendering, planning tools). However, it does not describe a clinical standalone performance study in the sense of an algorithm making a diagnostic or treatment decision without human involvement and comparing its output to a clinical ground truth. The device is explicitly "pre-planning software," implying human-in-the-loop usage.
7. The Type of Ground Truth Used
For the software validation described, the "ground truth" would be the expected behavior or output of the software as defined by its specifications and requirements. For example, during unit testing, the ground truth for a specific module's output would be what the developer intended it to produce given a set of inputs. For integration testing, it would be the correct interaction between modules. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient data) being used for performance evaluation.
8. The Sample Size for the Training Set
There is no mention of a training set in the context of machine learning or AI models. This submission is from 2011, and while some "advanced" features are listed (e.g., "Segmentation Wizard"), the documentation does not describe an AI/ML-driven system that would typically require a training set of labeled data in the modern sense. The "training" here refers to software development and validation processes, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set as understood in AI/ML context.
Summary of Approach in the Document:
The provided document details a 510(k) Special Premarket Notification for SimPlant 2011. The primary focus of a 510(k) is to demonstrate substantial equivalence to a predicate device. This typically involves:
- Comparing Intended Use: Showing the new device has the same purpose.
- Comparing Technological Characteristics: Identifying similarities and differences with the predicate.
- Demonstrating Safety and Effectiveness of Differences: Proving that any novel features or modifications do not introduce new risks or reduce effectiveness. This generally relies on non-clinical performance data (e.g., engineering tests, software validation, bench testing) and adherence to recognized standards, rather than large-scale clinical trials or detailed performance studies with patient data and expert ground truth.
Therefore, the "acceptance criteria" and "studies" mentioned are largely about internal software development validation, quality system compliance, and regulatory comparison, not comprehensive clinical performance evaluation against a defined clinical ground truth.
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JUL - 1 2011
SECTION 10 510(K) PREMARKET NOTIFICATION SUMMARY
SUBMITTER'S NAME AND ADDRESS: MATERIALISE DENTAL NV Technologielaan 15 B-3001 Leuven, Belgium 3006638827 ESTABLISHMENT REGISTRATION NO: Peter Vandeput, Materialise Dental NV CONTACT PERSON: Quality Manager +32 163 960 39 (tel) +32 163 966 22 (fax) peter vandeput@materialise.be November 15, 2010 SUMMARY PREPARATION DATE: Trade Name SimPlant 2011
Common Name:
Image processing system and preoperative software for simulating dental implant placement and surgical treatment options
CLASSIFICATION NAME:
System, Image Processing. This product uses images acquired from Computerized Tomography (CT) scanners.
PREDICATE DEVICE
SimPlant Dr James (K053592)
FUNCTION
The modified SimPlant System is used to transfer images from a medical scanner and to perform a segmentation of the images. It is also used to provide a means for pre-operative planning. Surgical templates may be fabricated based on the output of the pre-operative planning.
INTENDED USE
SimPlant 2011 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 pro-planning software for dental implant placement and surgical treatment.
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TECHNOLOGICAL COMPARISON OF DEVICES
| Feature | SimPlant 2011 | SimPlant System |
|---|---|---|
| Material | Software - magnetic media | Software - magnetic media |
| Design | Software for use in pre-operative planning.Volume Rendering Direct Volume Rendering ISO Surface X-Ray Rendering Maximum Intensity Projection Rendering 16bit compatibility Segmentation Wizard Reorient axial images to occlusal plane Advanced virtual teeth Advanced grafts and Volumes Dual scan registration Optical scan registration Optical Scannner support Optical scan for .sim files Occlusion tool Virtual occludator Advanced Soft tissue simulation OMS-3D Photomapping Surgical Guide Wizard | Software for use in pre-operative planning.Volume Rendering Direct Volume Rendering No ISO Surface No X-Ray Rendering No Maximum Intensity Projection Rendering 16bit compatibility No Segmentation Wizard No Reorient axial images to occlusal plane Virtual teeth Grafts and Volumes No dual scan registration No optical scan registration No Optical Scannner support No Optical scan for .sim files No occlusion tool No virtual occludator Soft tissue simulation No OMS-3D Photomapping Surgical Guide Wizard |
| Function | SimPlant 2011 provides a means fortransferring patient images from a medicalscanner to an output file.SimPlant 2011 is used to provide ameans for advanced pre-operativeplanning of dental implant placements andorthognatic treatment.SimPlant 2011 is used to provide ameans for image segmentation.SimPlant 2011 contains a library of dentalImplants.Surgical templates may be designed andfabricated based on the output of the pre- operative planning. | SimPlant System provides a means fortransferring patient images from a medicalscanner to an output file.SimPlant System is used to provide ameans for pre-operative planning of dentalimplant placements and orthognatictreatment.SimPlant System is used to provide ameans for image segmentation.SimPlant contains a library of dentalimplants.Surgical templates may be designed andfabricated based on the output of the pre- operative planning. |
SimPlant System Special 510(k) -- Premarket Notification
SimPlant System Special 510(k) -- Premarket Notification
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Non-clinical testing and software validation
The SimPlant 2011 software originates from the same medical software platform as the SimPlant system marketed by Materialise Dental and cleared under K033849.
Thorough testing has been performed. This software product does not contact the patient and does not deliver medication or therapeutic treatment.
For the SimPlant software, non-clinical testing was performed, in accordance with the following Standards:
- ISO 13485:2003 Medical devices Quality Management Systems.
- IEC 62304:2006 Medical device software Software life cycle processes
- EN ISO standard 14971:2007 Medical Device Application of risk management to devices.
The SimPlant software is tested in accordance with a documented test plan. This test plan is derived from the final specifications and ensures that all controls and procedures are functioning properly. It defines what is to be accomplished through the software validation effort. The testing of the software typically consists of Unit testing, Integration testing, IR testing, Smoke testing, different types of Formal testing (General testing, Reference testing, Usage testing), Acceptance testing, Alpha testing and Beta testing,
The tests are intended to establish how the software reacts to usual inputs and to unexpected or invalid inputs (verifying robustness). Software testing includes both static and dynamic analysis of the software. Static evaluation techniques include inspections, walkthroughs, etc. and are intended to find, correct and prevent problems in an early stage of the development process. They are used to focus or augment dynamic analysis, which is concerned with demonstrating the software's run-time behavior in response to selected inputs and conditions.
The results of the complete testing are on file in the offices of Materialise Dental and are contained within the Design History File.
CONCLUSION
The modified SimPlant 2011 is considered to be substantially equivalent in design, material and function to the unmodified SimPlant (Dr. James). It is believed to perform as well as the predicate device for pre-operative planning and for image segmentation. Accordingly, we respectfully request the Agency to expeditiously find this special 510(k) premarket notification to be Substantially Equivalent.
Plant System Special 510(k) -- Premarket Notification
Materialise Dental NV
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL - 1 2011
Mr. Peter Vandeput Quality Manager. Regulatory Affairs Representative Materialise Dental NV Technologietaan 15, 3001 Leuven BELGIUM
Re: K110300
Trade/Device Name: SimPlant 2011 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 21, 2011 Received: June 23, 2011
Dear Mr. Vanderput:
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 vour 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,
Mary S. Patil
Mary S. Pastel. Sc.D. 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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Indications for Use Form
510(k) Number (if known): K110300
Device Name: SimPlant 2011
Indications for Use:
SimPlant 2011 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael D O'Hern
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 110300
Page 1 of 1
§ 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).