(41 days)
- Aiding diagnosis in the oral-maxillofacial region
- Aiding comparisons of different treatment options
- · Aiding endodontic treatment planning
- · Aiding treatment planning for endodontic surgical guides
SICAT Endo is a pure software device. SICAT Endo is a software tool intended for viewing and analyzing medical information:
- medical 3D volume data such as volumetric X-ray data from Cone Beam CT (CBCT) and CT scanners, and
- . intraoral images, and
- . 3D optical surface data like optical impression data from optical scanners, and
SICAT Endo provides tools for analyzing the root canal and to mark it visually. It allows to define a drill canal and ordering of a corresponding surgical quide with a drill sleeve.
The provided document is a 510(k) summary for the SICAT Endo device. It outlines the device's intended use, comparison to predicate devices, and non-clinical performance testing. The information required for a detailed description of acceptance criteria and the study proving compliance is scattered throughout the text.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states quantitative acceptance criteria for length and angular measurements.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Length Measurement Accuracy: 100 μm | 100 μm (Implied - "Accuracy") |
| Overall Angular Measurement Accuracy: 1 degree | 1 degree (Implied - "Accuracy") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set.
It states that "Special bench testing has been performed with non-clinical data" to verify the endodontic planning visualization quality and effectiveness and overall quantitative accuracy of the root canal treatment planning. The provenance of this "non-clinical data" (e.g., country of origin, retrospective/prospective) is not explicitly mentioned. Given the device is for dental applications and comparison to a predicate sold in the EU/USA, the data would likely be from relevant patient populations, but this is not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the non-clinical bench testing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human readers improving with AI vs. without AI assistance. The testing focuses on "non-clinical data" and "visualization quality and effectiveness," and "quantitative accuracy," implying an evaluation of the software's inherent functions rather than human-in-the-loop performance.
6. Standalone Performance Study
Yes, a standalone study (algorithm-only performance) was done. The "Special bench testing" focused on verifying the "endodontic planning visualization quality and effectiveness" and "overall quantitative accuracy of the root canal treatment planning." This type of testing evaluates the device's performance in isolation.
7. Type of Ground Truth Used
The document states "Special bench testing has been performed with non-clinical data" to verify accuracy. For quantitative accuracy measurements like length and angle, the ground truth would typically be established based on known physical measurements or highly precise anatomical references within the non-clinical data (e.g., phantoms, synthetic models, or highly accurate previous measurements from a gold standard). The specific nature (e.g., expert consensus, pathology, outcomes data) is not explicitly stated beyond "non-clinical data." However, for "quantitative accuracy," it can be inferred that a precisely measured ground truth would be used.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set. This is a 510(k) summary for a premarket notification, and such details about internal model development (like training data) are not typically required or disclosed at this stage for a device like this, which is described more as a "visualization" and "planning" software rather than a purely AI-driven diagnostic tool that learns from large datasets. The device description emphasizes "tools for analyzing the root canal and to mark it visually" and "define a drill canal," suggesting a feature-based software rather than deep learning that requires extensive training data.
9. How the Ground Truth for the Training Set Was Established
Since no information on a training set is provided, the method for establishing its ground truth is also not available in this document.
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March 12, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SICAT GmbH & Co. KG % Frederik Kunze Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, NRW 53177 GERMANY
Re: K180262
Trade/Device Name: SICAT Endo Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 29, 2018 Received: January 30, 2018
Dear Frederik Kunze:
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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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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Indications for Use
510(k) Number (if known) K180262
Device Name SICAT Endo
Indications for Use (Describe)
- Aiding diagnosis in the oral-maxillofacial region
- Aiding comparisons of different treatment options
- · Aiding endodontic treatment planning
- · Aiding treatment planning for endodontic surgical guides
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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Content and format as required by section 21 CFR 807.92
( http://www.fda.gov/ MedicalDevices/ DeviceRequlationandGuidance/ HowtoMarket YourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm)
1. SUBMITTER/510(K) HOLDER
SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn Germany
| EstablishmentRegistration Number: | 3006098230 |
|---|---|
| Telephone: | +49 (228) 854697-82 |
| Facsimile: | +49 (228) 854697-99 |
| Primary Contact: | Mr. Dr. Manfred Breuer |
| Secondary Contact: | Mr. Frederik Kunze |
| Date Prepared: | January 29th, 2018 |
2. DEVICE NAME AND DEVICE CLASSIFICATION
| Proprietary Name: | SICAT Endo |
|---|---|
| Common/Usual Name: | Radiological Visualization Software for Diagnosis and Dental |
| Treatment Planning | |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Description: | Picture archiving and communications system |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Classification Class: | Class II Product |
3. PREDICATE DEVICES
4. DEVICE DESCRIPTION
SICAT Endo is a pure software device.
SICAT Endo is a software tool intended for viewing and analyzing medical information:
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- 5 510(k) Summary for SICAT Endo
- medical 3D volume data such as volumetric X-ray data from Cone Beam CT (CBCT) and CT scanners, and
- . intraoral images, and
- . 3D optical surface data like optical impression data from optical scanners, and
SICAT Endo provides tools for analyzing the root canal and to mark it visually. It allows to define a drill canal and ordering of a corresponding surgical quide with a drill sleeve.
5. Indications for Use
Indications for use for SICAT Endo are:
- Aiding diagnosis in the oral-maxillofacial region
- . Aiding comparisons of different treatment options
- . Aiding endodontic treatment planning
- Aiding treatment planning for endodontic surgical quides .
6. Device Comparison Table
The following table shows a summary of the intended use, technological characteristics, design and function of SICAT Endo and the predicate devices. The predicate device SICAT Implant is the primary predicate device.
| SICAT Endo | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) | ||||
|---|---|---|---|---|---|---|
| Common / Usual Name | ||||||
| RadiologicalVisualizationSoftware forDiagnosis andEndodonticTreatment Planning | RadiologicalVisualization Softwarefor Diagnosis andEndodontic Treatmentand Re-treatmentPlanning | RadiologicalVisualizationSoftware forDiagnosis andDental ImplantPlanning | ||||
| Device Description | ||||||
| General Description | SICAT Endo is apure softwaredevice.SICAT Endo is asoftware applicationfor visualization ofimaging informationof the oral-maxillofacial region.The imaging data | 3D Endo™ is a CBCTbased software devicedesigned to improveendodontic treatmentplanning for morepredictability.It is designed toimprove treatmentquality: to isolate thetooth of interest, to | SICAT ImplantV1.2 is a puresoftware device.SICAT ImplantV1.2 is asoftwareapplication forthe visualizationof imaginginformation of | |||
| SICAT Endo | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) | ||||
| originates frommedical scannerssuch as CT or CBCTscanners. It is alsoused as a softwaresystem to aidmedicalprofessionals withthe planning, theevaluation and thecomparison oftreatment optionsand the planning ofendodontic accessesfor an endodontictreatment. Themedicalprofessionals'planning data maybe exported fromSICAT Endo andused for therealization of theplanned therapy. | clearly visualize thetooth anatomy in 3D,to identify all canalsand to anticipateareas.The use of 3D Endoprovides:- Diagnosis andpathology- 3D tooth anatomy- Canal system- 3D canal anatomy- Treatment planThe Wizard allows to:· Diagnose the case;• Isolate the tooth ofinterest;· Investigate thecanal system;• Understand the 3DCanal anatomy;· Create a Treatmentplan.The use of 3D Endoallows to:· evaluate 3D workinglength and cavityaccess depth• locate canal orificeswithout opening thetooth• plan for an optimalcavity access and yourfinal instrument· investigate canals'irregularities followingtheir curvaturesIn addition, thesimulated Intra-RootCamera View Visualize | the oral-maxillo-facial region. Theimaging dataoriginates frommedical scannerssuch as CT orDVT scanners.SICAT ImplantV1.2 is intendedfor use asplanning andsimulationsoftware to aidqualified dentalprofessionals inthe placement ofdental implantsand the planningof surgicaltreatments.SICAT ImplantV1.2 allows toname, position,move, rotate,resize andvisualize dentalimplants andother planningobjects (i.e.nerve canals)within thevisualized 3Dvolume. Thus,dentalprofessionals likeimplantologistsare enabled toprecisely planthe positions,orientations,types and sizesof implants to beplaced in thepatient'smandible/maxilla | ||||
| SICAT Endo | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) | ||||
| throughout the canalthe theoretical cuttingenvelope of theDentsply SironaEndodonticsinstruments. | together with therelated surgicalprocedures.The dentalprofessionals'planning datamay be exportedfrom SICATImplant V1.2 andused as inputdata for CAD orRapidPrototypingSystems. | |||||
| Indications for Use | ||||||
| Indications forUse | Aiding diagnosis inthe oral-maxillofacialregionAiding comparisonsof differenttreatment optionsAiding endodontictreatment planningAiding treatmentplanning forendodontic surgicalguides | 3D Endo™ Software isintended to aid in thevisualization,diagnosis andplanning ofendodontic treatmentand re-treatmentcases utilizing DICOMimages. | SICAT Implant isa softwareapplication forthe visualizationof imaginginformation ofthe oral-maxillofacialregion. Theimaging dataoriginates frommedical scannerssuch as CT orDVT scanners.SICAT Implant isintended for useas planning andsimulationsoftware to aidqualified dentalprofessionals inthe placement ofdental implantsand the planningof surgicaltreatments. Thedentalprofessionals | |||
| SICAT Endo | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) | ||||
| planning datamay be exportedfrom SICATImplant andused as inputdata for CAD orRapidPrototypingSystems. | ||||||
| Contraindications | None | Do not use 3D Endo™Software for implantsor any other dentalprocedure outsideendodontics.There are no knownserious adversereactions or potentialsafety hazards. | None | |||
| Medical Data Viewing | ||||||
| Data typesvisualized | 3D volume data, 3Dsurface data (opticalimpressions), 2Dradiographs | 2D and 3D visualizedCBCT data | 3D volume data,3D surface data(opticalimpressions,implant objects) | |||
| Imaging datavisualizationregion | Oral-maxillofacialregion | Oral-maxillofacialregion | Oral-maxillofacialregion | |||
| Viewing Modes typically used for dental procedures | ||||||
| *Orthogonalslices | Axial, coronal,sagittal within theEndoline wizard | Axial | Axial, coronal,sagittal | |||
| *Panoramic view | Panoramic view (raysum) based on apanoramic curve.Panoramic curve canbe manuallyadjusted. | No | Panoramic view(ray sum) basedon a panoramiccurve.Panoramic curvecan be manuallyadjusted. | |||
| Curved PlanarReformation | Curved planarreformation based | Yes | None | |||
| SICAT Endo | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) | ||||
| (CPR) also calledMulti PlanarReformation(MPR) that isless precise | on a splinepositioned within thevolume. Bypositioning thespline the view isadjusted.No equidistant scale. | |||||
| *Panoramic slice | Movable "PanoramicSlicing Window"embedded inpanoramic view | No | Movable"PanoramicSlicing Window"embedded inpanoramic view | |||
| *TSA and LSA | Transversal slice(TSA) andlongitudinal slice(LSA), both withrespect topanoramic curve | Transversal slice | Transversal slice(TSA) andlongitudinal slice(LSA), both withrespect topanoramic curve | |||
| *3D volumerendering | Yes | Yes | Yes | |||
| *3D surfacerendering ofvolume data | Yes | No | Yes | |||
| 2D radiographson 3D volumetricdata | Yes | No | No | |||
| Volume Data Navigation and Manipulation | ||||||
| *Viewmanipulatingtools | Zoom, Pan, Changeof orientation | Zoom, Pan, Change oforientation | Zoom, Pan,Change oforientation | |||
| *Colormanipulatingtools | Brightness, Contrast | Brightness, Contrast | Brightness,Contrast | |||
| *Scrollingthrough slices | Yes | Yes | Yes | |||
| Measurements | ||||||
| *Overall LengthMeasurement | 100 μm | ± 0.5 mm | 100 μm | |||
| SICAT Endo | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) | ||||
| Accuracy | ||||||
| *Overall AngularMeasurementAccuracy | 1 degree | $\pm$ 5° | 1 degree | |||
| Optical Surface Data Visualization | ||||||
| *Rendering ofoptical surfacedata | Yes, 3D | No | Yes, 3D | |||
| Optical Surface Data Manipulation | ||||||
| *Registration ofsurface data(from opticalimpressions) tovolume data | Semi-automatic,using user specifiedreference points. | n/a | Semi-automatic,using userspecifiedreference points. | |||
| Input / Output (I/O) | ||||||
| *Volume dataimport | DICOM | DICOM | DICOM | |||
| *Optical surfacedata / opticalimpressionimport | Standard STL formatand proprietary SSIor SIXD containerformat.Features andAlgorithms identicalto SICAT Implant. | No | Standard STLformat andproprietary SSI. | |||
| *DataCompression | Lossless ZIPcompression | n/a | Lossless ZIPcompression | |||
| Export of data forrealization ofplanned therapy | Yes | No | Yes | |||
| *Marking of rootcanal pathways | Yes | Yes | No | |||
| Planning ofdrillpaths | Yes | No | Yes | |||
| Programming Language | ||||||
| SICAT Endo | C# and C++ | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | no data available | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) | C# and C++ | |
| Minimum Technical Requirements | ||||||
| PC Hardwarerequirements(minimum) | Operating System:Windows 7 64-bitSP1+ "PlatformUpdate" KB2670838,Windows 8 64-bit(Desktop), Windows8.1 64-bit (Desktop),Windows 10 64-bitCPU: Quad Core 2.3GHzRAM: 8 GBHDD: 20 GB freespaceVideo card: 1 GBRAM (dedicated),must supportDirectX 11 or higher,feat driver WDDM1.0 or higher, e.g.NVidia GTX 960(2GB RAM)Screen: 1980x1080(Full HD), Scaling100 % - 125 %,Resolution max.3840x2160, Scaling100 % - 200 %must pass test withSMPTE Test patternAdditionalrequirements whenrunning as SIDEXISXG-DirectDental-Plug-In: Sidexis XG:Version 2.6.1 (64Bit) or Sidexis 4, V4.1.2 (64 Bit)Additionalrequirements whenrunning as SIDEXIS4 Module: SIDEXIS | Operation systems:Windows 7, 8.1 or 10;64-bitProcessor: 3rdGeneration Intel®Core™ Processors orhigherRAM: 4 GB or moreFree disk space: 20GB or moreGraphical cardrequirements: On-board Intel® HDGraphics 2500 orhigherScreen resolution:1024 x 768 or betterOpen GLrequirements: Version3.2 or higher | OperatingSystem:Windows XPProfessional (32-bit) with SP3 and.NET 2.0RuntimeLibraries orWindows VistaBusiness (32-bit)with SP2 orWindows 7Professional (32-bit or 64-bit)with SP1CPU: Dual Core1.6 GHzRAM: 2 GBFree space onHDD: 5 GBVideo card: 128MB externalvideo card, 24-bit color, ShaderModel 3 (foradvanced 3Drendering)Screenresolution:1280x1024 pixels |
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| SICAT Endo | 3D Endo, DentsplySirona(marketed in EU /USA cleared under510(k) K171115) | SICATImplant,SICAT(marketed inEU / USAcleared under510(k) numberK103723) |
|---|---|---|
| 4: Sirona PlanningAPI V4 (starting withSIDEXIS V 4.2) |
- for functions and algorithms used in SICAT Implant and SICAT Endo having the same principle;
Missing features of SICAT Endo compared to the predicate device SICAT Implant are connected to implant planning. This does not impact the safety and effectiveness of SICAT Endo concerning the visualization of imaging information and treatment planning and evaluation.
Except for the CPR view the software algorithms used in SICAT Endo are similar to the predicate device SICAT Implant. Performance testing has been used to validate the safety and effectiveness of the SICAT Endo device in comparison to the predicate device 3D Endo regarding endodontic planning features, including the CPR view.
7. Non-Clinical Performance Testing and Verification and Validation Activities
For SICAT Endo, software verification and validation activities were performed, in accordance with the following quidance and standards:
- Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 2002
- AAMI/ANSI/IEC 62304:2006, Medical device software Software life cycle processes ●
- IEC 62366-1, Medical devices Application of usability engineering to medical ● devices
- ISO 14971:2007, Medical devices Application of risk management to medical . devices.
Among others the following verification and validation activities were performed:
- Design Validation/Reviews ●
- Unit Tests .
- Code Reviews ●
- Usability Tests ●
- Integration Tests ●
- System Verification Tests ●
- User Site Tests .
Special bench testing has been performed with non-clinical data:
- . to verify the endodontic planning visualization quality and effectiveness
- overall quantitative accuracy of the root canal treatment planning .
Test reports for integration testing, system verification and validation testing and bench testing are included with this premarket notification.
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A verification and validation activities summary report provided with this premarket notification concludes that SICAT Endo passed all verification and validation activities and that safety and effectiveness of the product has been demonstrated in the context of its intended use.
8. Conclusion
Based on the information and supporting documentation provided in the premarket notification, SICAT Endo is considered to be comparable in design, material and function to the predicate devices. It is believed to perform as well as the predicate devices for the visualization of imaging data together with optical impression data, the diagnostic purpose, and the technological approach of planning drill canals and the evaluation of dental treatment options. Any minor differences between SICAT Endo and the predicate devices do not effect safety and effectiveness.
§ 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).