(252 days)
SIMPLANT 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. It is also intended as pre-planning software for dental implant placement and surgical treatment.
The proposed device SIMPLANT 18 is stand-alone software intended for pre-operative planning of dental implant placement and surgical treatment options, without patient contact. A SIMPLANT project file is created from patient image data, patient information, and implants data which are aggregated together. The SIMPLANT project file is the basis for continued implant surgical planning by dental professionals. The dental plan, which is the result of the dental implant planning process, can be used for manufacturing of a surgical guide or for evaluation of treatment options during the implant surgery procedure.
Here's an analysis of the provided text regarding the acceptance criteria and study for SIMPLANT 18:
Note: The provided document is a 510(k) summary for a medical device (SIMPLANT 18). While it outlines the software's functionality and a general approach to testing for substantial equivalence, it does not contain detailed acceptance criteria, specific performance metrics, or a formal clinical study report with detailed results, sample sizes, and expert qualifications as would be found in a comprehensive clinical trial write-up. The information presented is focused on demonstrating that the new version is substantially equivalent to a previously cleared device, rather than proving performance against specific acceptance criteria with quantifiable metrics.
Acceptance Criteria and Study for SIMPLANT 18
Based on the provided 510(k) summary, formal, quantitative acceptance criteria and a detailed clinical study demonstrating device performance against those criteria are not explicitly provided in the typical format of a clinical trial report. The document focuses on demonstrating substantial equivalence to a predicate device (SimPlant 2011) through software verification and validation activities.
1. A table of acceptance criteria and the reported device performance:
As mentioned, explicit, quantifiable acceptance criteria with corresponding performance metrics are not detailed in this document. The "performance" is generally described as the software fulfilling "all user needs and performance requirements according to the design inputs" and that functionality is confirmed through various software tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality for dental implant pre-operative planning. | Confirmed through Peer Code Review, Integration test, Internal release test, Smoke test, Formal system test, Acceptance test, Beta test. |
| Accurate image segmentation and transfer from medical scanners. | Confirmed through software verification and validation activities. |
| Correct functioning of new features (e.g., improved virtual teeth, immediate smile). | Confirmed through software verification and validation activities. |
| Safe and effective operation as intended. | Confirmed through software verification and validation activities, and deemed substantially equivalent to predicate. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "software testing" and "verification and validation testing" without detailing the number of test cases, patient datasets, or specific scenarios used in these tests.
- Data Provenance: Not specified. The origin of any data used for testing (e.g., country of origin, retrospective or prospective collection) is not mentioned. It is implied that typical medical image data (CT, CBCT) would be used for testing the functionalities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The document states the "User" for both proposed and predicate devices is "Medically trained people," implying testing would likely involve such individuals, but explicit details about experts for ground truth are absent.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: No. The document does not describe an MRMC comparative effectiveness study, nor does it refer to AI assistance for human readers in the context of effectiveness improvement. This device is described as "standalone software" for pre-planning, which itself is a tool for medical professionals, not explicitly an "AI assistance" system in the sense of improving human reader diagnostic accuracy in a comparative study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The device SIMPLANT 18 is described as "stand-alone software" whose functionalities (like image segmentation, measurement tools, planning tools) are tested through various software verification and validation activities. These tests verify the algorithm's performance and the software's functionality without necessarily a human "in-the-loop" for performance measurement in the context of a clinical study, but rather to ensure the software performs as designed for human practitioners to use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified. Given the nature of dental implant planning software, ground truth for functional verification would likely involve:
- Design Specifications/Requirements: The software is tested against its own design inputs.
- Reference Data/Models: For features like measurements, segmentation, and implant placement visualization, ground truth might involve known anatomical measurements, accurately segmented 3D models, or expert-defined optimal implant positions.
- Comparison to Predicate: Implicitly, the performance is benchmarked against the predicate device's known performance.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/Not specified.
The document describes SIMPLANT 18 as software with various functionalities (segmentation, measurement, visualization, planning tools). It does not indicate that the software uses machine learning or AI models that would require a "training set" in the conventional sense of supervised learning. The changes are described as functional improvements, clarifications, and iterative updates to existing software.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable/Not specified, as no training set for an AI model is mentioned.
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April 4, 2018
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Dentsply Sirona % Mr. Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W YORK PA 17401
Re: K172239
Trade/Device Name: SIMPLANT 18 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 20, 2018 Received: February 26, 2018
Dear Mr. Nittinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Karl Nittinger
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name SIMPLANT 18
Indications for Use (Describe)
SIMPLANT 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. It is also intended as pre-planning software for dental implant placement and surgical treatment.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
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510(k) SUMMARY For S1MPLANT 18
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
- Submitter Information:
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
February 22, 2018 Date Prepared:
-
- Device Name:
| • Proprietary Name: | Simplant 18 |
|---|---|
| • Classification Name: | Picture archiving and communications system |
| • CFR Number: | 892.2050 |
| • Device Class: | II |
| • Product Code: | LLZ |
-
- Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| SimPlant 2011 | K110300 | Materialise Dental NV |
-
- Description of Device:
The proposed device SIMPLANT 18 is stand-alone software intended for pre-operative planning of dental implant placement and surgical treatment options, without patient contact.
- Description of Device:
A SIMPLANT project file is created from patient image data, patient information, and implants data which are aggregated together. The SIMPLANT project file is the basis for continued implant surgical planning by dental professionals.
The dental plan, which is the result of the dental implant planning process, can be used for manufacturing of a surgical guide or for evaluation of treatment options during the implant surgery procedure.
The purpose of this premarket notification is to gain clearance for new features implemented in the latest software version, clarification of the indications for use, as well as to document iterative changes to the software that have been implemented since the original clearance under K0110300.
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-
ર. Indications for Use:
SIMPLANT 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. It is also intended as pre-planning software for dental implant placement and surgical treatment. -
б. Substantial Equivalence:
Technological Characteristics:
The proposed SIMPLANT 18 is stand-alone medical device software, used without patient contact.
| Element | Proposed deviceSIMPLANT 18 | Predicate deviceSimPlant 2011K110300 | Difference |
|---|---|---|---|
| Manufacturer | DENTSPLY Implants NV(formerly Materialise DentalNV) | Materialise Dental NV | No |
| Indications for use | SIMPLANT is intended foruse as a software interfaceand image segmentationsystem for the transfer ofimaging information from amedical scanner such as a CTscanner.It is also intended as pre-planning software for dentalimplant placement andsurgical treatment. | SimPlant 2011 is intendedfor use as a softwareinterface and imagesegmentation system for thetransfer of imaginginformation from a medicalscanner such as a CTscanner or a MagneticResonance scanner.It is also intended as pre-planning software fordental implant placementand surgical treatment. | Yes |
| User | Medically trained people. | Medically trained people. | No |
| Functions | File open/save tools | ||
| (CB)CT images import | (CB)CT images import | No | |
| Open project | Open project | No | |
| Save project | Save project | No | |
| Visualization tools | |||
| 2D gray value images | 2D gray value images | No | |
| 3D viewing | 3D viewing | No | |
| Navigation(Zoom/Pan/Rotate) | Navigation(Zoom/Pan/Rotate) | No | |
| Element | Proposed deviceSIMPLANT 18 | Predicate deviceSimPlant 2011K110300 | Difference |
| Volume rendering | Volume rendering | No | |
| Segmentation tools | |||
| Segmentation wizard | Segmentation wizard | No | |
| Measurement tools | |||
| Distance | Distance | No | |
| Angle | Angle | No | |
| Density | Density | No | |
| Preparation tools | |||
| Dual scan registration- Soft tissue creationpossibility | Dual scan registration- No soft tissuecreation possibility | Yes | |
| Optical scan registration- Intraoral scan- Plaster cast scan andadditional 3D modelscans | Optical scan registration- Intraoral scan- Plaster cast scan | Yes | |
| Panoramic curve | Panoramic curve | No | |
| Nerve | Nerve | No | |
| Improved Virtual teeth | Virtual teeth | Yes | |
| Grafts and volumes | Grafts and volumes | No | |
| Reorient axial images toocclusal plane | Reorient axial images toocclusal plane | No | |
| Planning tools | |||
| Implant Library- Immediate smilefeaturing Atlantisabutment | Implant Library | Yes | |
| Place implant | Place implant | No | |
| Draw implant | Draw implant | No | |
| Edit implant- Multiple implantMovement | Edit implant | Yes | |
| Collision detection | Collision detection | No | |
| Request SIMPLANTguide wizard | Request SIMPLANTguide wizard | Yes | |
| Element | Proposed deviceSIMPLANT 18 | Predicate deviceSimPlant 2011K110300 | Difference |
| - with automatictransfer tomySIMPLANT.com | - with automatictransfer toOnline Shop | ||
| - | Occlusion toolVirtual occludatorSoft tissue simulation | Yes | |
| Media for delivery | Software - file for download. | Software - magnetic media(DVD). | Yes |
| Principles ofoperation | Desktop application. | Desktop application. | No |
| Program language | C++ | C++ | No |
| Operating system | Windows | Windows | No |
Table 5-1 Substantial Equivalence Comparison Table
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Analysis of differences:
The indications for use statement has been clarified to remove the example related to image import from a magnetic resonance scanner as it is not possible to import data from magnetic resonance scanning equipment into the subject SIMPLANT software.
Functionality changes are implemented to improve usability:
- Scan registration is expanded to allow for soft tissue creation and for import of 3D model scans to help the user when determining the ideal implant position. The improved Virtual teeth function offers more options and flexibility to shape and position the virtual teeth. The additional "multiple implant movement" function makes it easier for a user to simultaneously alter the positions of more than one implant relative to the bone, thereby maintaining their initial positions relative to one another.
- । In the predicate device, the complete Implant library had to be downloaded for each library update. In the proposed device, a partial upload is possible, and as such, reduces the download time for the user.
- । The new feature "Immediate Smile featuring Atlantis abutments" makes it easier for the user to see which implants are compatible with customized ATLANTIS Abutments. Also, the design of this abutment can be imported and made visible in the planning file of the proposed SIMPLANT 18.
The "Occlusion tool", "Virtual occludator" and "Soft tissue simulation" functions have been removed from the software's functionality.
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The website for ordering patient specific surgical guides has changed. Consequently, the proposed SIMPLANT 18 directs the user automatically to the new mySIMPLANT web page instead of to the former Online Shop for ordering the guide.
The media for delivery of the proposed device has been changed. The original software was delivered on DVD, whereas the proposed device is delivered via file download for installation.
Summary of Software testing:
Software verification and validation was conducted to ensure the functionality and have been included to support the substantial equivalence of the subject SIMPLANT 18 software.
In principle, the software testing has consisted of testing of the software functionality containing the changes introduced since the approved predicate device SimPlant 2011 (K110300). . Software testing has been conducted in accordance with the software life cycle processes, as defined in IEC 62304.
The verification and validation testing has consisted of the following activities:
- Peer Code Review .
- Integration test .
- Internal release test .
- Smoke test •
- Formal system test ●
- Acceptance test .
- Beta test .
The results of verification and validation confirm that all user needs and performance requirements according to the design inputs are fulfilled.
7. Conclusion Regarding Substantial Equivalence:
The proposed SIMPLANT 18 is software 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. It is also intended as pre-planning software for dental implant placement and surgical treatment.
The proposed SIMPLANT 18 software, which is the subject of this premarket notification, has the same intended use and similar indications for use, incorporates the same technological characteristics and principles of operation as the predicate SimPlant 2011 (K110300) device. SIMPLANT 18 is tested and validated in the same way as the predicate SimPlant 2011 (K110300) device. Test data to verify the performance of the proposed SIMPLANT 18 have been included and the results of this testing confirmed the functionality and support the substantial equivalence of the proposed device SIMPLANT 18.
§ 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).