(120 days)
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.
SICAT Function is a pure software device. SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT scanners. This information can be complemented by the imaging information from optical impression systems and jaw tracking devices. The additional information about the exact geometry of the tooth surfaces and the mandibular movement can be visualized together with the radiological data. SICAT Function is also used as a software system to aid qualified dental professionals with the evaluation and planning of dental treatment options. The dental professionals' treatment planning information may be exported from SICAT Function to be used as input data for the manufacturing of therapeutic devices such as oral appliances.
The provided text describes the regulatory submission for "SICAT Function," a software device. While it outlines the device's intended use, comparison with predicate devices, and a list of verification and validation activities, it does not contain specific acceptance criteria or a detailed study report proving the device meets those criteria with quantitative performance metrics, sample sizes, or ground truth establishment details.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, material, and function, rather than presenting a standalone performance study with defined acceptance criteria.
However, based on the provided text, here's an attempt to answer the questions, highlighting where information is not available:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the SICAT Function's performance. Instead, it relies on demonstrating that the device "passed all verification and validation activities" and "safety and effectiveness of the product has been demonstrated in the context of its intended use" as compared to predicate devices.
Acceptance Criteria (Implicit from the text):
- Successful correct import, registration, and visualization of jaw motion data.
- Demonstrated safety and effectiveness of image segmentation features.
- Substantial equivalence in design, material, and function to predicate devices for visualization, segmentation, and evaluation of dental treatment options.
Reported Device Performance:
| Feature/Metric | Reported Performance |
|---|---|
| Jaw Motion Data Handling | "Special bench testing has been performed with non-clinical data: to verify the correct import, registration and visualization of jaw motion data." (Page 5) The conclusion states: "SICAT Function passed all verification and validation activities and that safety and effectiveness of the product has been demonstrated in the context of its intended use." (Page 6) |
| Image Segmentation | "Special bench testing has been performed with non-clinical data: to verify the safety and effectiveness of image segmentation features." (Page 5) The conclusion states: "SICAT Function passed all verification and validation activities and that safety and effectiveness of the product has been demonstrated in the context of its intended use." (Page 6) |
| Overall Performance | "It is believed to perform as well as the predicate devices for the visualization and segmentation of imaging information and the evaluation of dental treatment options." (Page 6) |
Missing Information Details:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "Special bench testing has been performed with non-clinical data" (Page 5) but does not specify the sample size (number of cases/patients), the type or origin of this non-clinical data, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. The document does not describe how ground truth was established for the "special bench testing."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. There is no mention of any adjudication method for establishing ground truth or evaluating test results.
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 Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. The document primarily describes software verification and validation, along with bench testing. There is no indication of a study involving human readers or comparing performance with and without AI assistance. This device is described as "aid[ing] qualified dental professionals" (Page 1) and "pure software device" (Page 2), implying it's a tool, but no human-in-the-loop performance study is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "Special bench testing" (Page 5) for jaw motion data and image segmentation appears to be a standalone performance evaluation of the algorithms/software features, as it doesn't mention human interaction. The overall verification and validation activities also support a standalone software evaluation. However, specific quantitative metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Available directly. For the "special bench testing" with "non-clinical data" (Page 5), the method for establishing ground truth is not described. Given the nature of a software device for visualization and segmentation, ground truth would likely be based on idealized or known synthetically generated data for bench testing, or expert manual segmentation/annotation on real data, but this is not specified.
8. The sample size for the training set
- Not Applicable / Not Available. The document does not mention the use of a "training set" in the context of machine learning or AI development. The device is purely software for visualization and segmentation, which might rely on deterministic algorithms, rather than models that require training data. If any machine learning components were present, the training set size is not disclosed.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. As no training set is mentioned, the method for establishing its ground truth is also not provided.
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K133320
Page 1 of 6
510(k) Summary for SICAT Function
FEB 2 5 2014
Content and format as required by section 21 CFR 807.92 ( http://www.fda.gov/ MedicalDevices/ DeviceRequlationandGuidance/ HowtoMar ketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.
htm)
1. SUBMITTER/510(K) HOLDER
SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn Germany
Establishment Registration Number:
3006098230
| Telephone: | +49 (228) 854697-82 |
|---|---|
| Facsimile: | +49 (228) 854697-99 |
| Primary Contact: | Mr. Dr. Manfred Breuer |
| Secondary Contact: | Mr. Frederik Kunze |
October 17th, 2013 Date Prepared:
2. DEVICE NAME AND DEVICE CLASSIFICATION
| Proprietary Name: | SICAT Function |
|---|---|
| Common/Usual Name: | Radiological Visualization Software for Diagnosis and DentalTreatment 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 Function is a pure software device.
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT scanners.
This information can be complemented by the imaging information from optical
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5 510(k) Summary for SICAT Function
impression systems and jaw tracking devices. The additional information about the exact geometry of the tooth surfaces and the mandibular movement can be visualized together with the radiological data.
SICAT Function is also used as a software system to aid qualified dental professionals with the evaluation and planning of dental treatment options.
The dental professionals' treatment planning information may be exported from SICAT Function to be used as input data for the manufacturing of therapeutic devices such as oral appliances.
5. Intended Use
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to . aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.
6. Device Comparison Table
The following table shows a summary of the intended use, technological characteristics, design and function of SICAT Function and the predicate devices.
| SICAT FunctionProposed | SICAT ImplantK103723 | Materialise SimPlantV 12.0 with OMSModule (K033849,K053592, K081402) | |
|---|---|---|---|
| Intended Use | |||
| SICAT Function is asoftware applicationfor the visualizationand segmentation ofimaging information ofthe oral-maxillofacialregion. The imagingdata originates frommedical scanners suchas CT or CBCTscanners. It is alsoused as a softwaresystem to aid qualifieddental professionalswith the evaluation ofdental treatmentoptions. The dentalprofessionals' planningdata may be exportedfrom SICAT Functionand used as input datafor CAD or RapidPrototyping Systems. | SICAT Implant is asoftware applicationfor the visualization ofimaging information ofthe oral-maxillofacialregion. The imagingdata originates frommedical scanners suchas CT or DVTscanners. SICATImplant is intended foruse as planning andsimulation software toaid qualified dentalprofessionals in theplacement of dentalimplants and theplanning of surgicaltreatments. The dentalprofessionals planningdata may be exportedfrom SICAT Implantand used as input datafor CAD or RapidPrototyping Systems. | The SimPlant System isintended for use as asoftware interface andimage segmentationsystem for the transfer ofimaging information froma medical scanner such asa CT scanner or aMagnetic Resonancescanner. It is alsointended as pre-planningsoftware for dentalimplant placement andsurgical treatment.Materialise Dental'sSimPlant Ortho 3Dsoftware is indicated foruse as a medical front-end software that can beused by medically trainedpeople for the purpose ofvisualizing gray valueimages. It is intended foruse as a softwareinterface and image | |
| SICAT FunctionProposed | SICAT ImplantK103723 | Materialise SimPlantV 12.0 with OMSModule (K033849,K053592, K081402) | |
| segmentationsystem for the transfer ofimaging information froma medical scanner such asa CT scanner or MagneticResonance scanner. It isalso used as a softwaresystem forsimulating/evaluatingorthodontic treatment i.e.dental bite options. | |||
| Technological Characteristics and Function | |||
| Material | pure software device | pure software device | |
| Operatingsystem | Windows | Windows | |
| Program-minglanguage | C# and C++ | C++ | |
| Medical Data I/O | |||
| Volume dataimport | DICOM | DICOM | |
| Opticalsurface data/opticalimpressionimport | Standard STL formatand proprietary SSIcontainer Format. | Standard STL format andproprietary OrthoPlexformat. | |
| Jaw motiontracking data | No | No | |
| Export ofdata for CADand rapidproto-typing | Yes | Yes | |
| Medical Data Viewing | |||
| Data typesvisualized | 3D volume data,optical impressions | 3D volume data, opticalimpressions | |
| 2D SliceViews | axial, coronal, sagittal,dental panorama,dental tangential andcross-sectional sliceviews | axial, coronal, sagittal,dental panorama, dentalcross-sectional slice view,cephalometric | |
| 3D Volumerendering | Yes | Yes | |
| 3D Surfacerendering | Yes | Yes | |
| Viewmanipu-lating tools | Scroll, Zoom, Pan,Change of orientation,Brightness, Contrast | Scroll, Zoom, Pan,Change of orientation,Brightness, Contrast | |
| Measure-ments | Length, Angle, Greyvalues | Length, Angle, Greyvalues | |
| Segmen-tation (i.e. ofmandible) | No | Yes, using a segmentationwizard | |
| SICAT FunctionProposed | SICAT ImplantK103723 | Materialise SimPlantV 12.0 with OMSModule (K033849,K053592, K081402) | |
| Registrationof opticalimpressiondata tovolume data | Yes | Yes | Yes |
| Evaluation ofocclusionbased onopticalimpressiondata | Only visually | No | Yes, color coded |
| Misc. functions | |||
| Simulation oforthodonticprocedures,osteotomiesanddistractions. | No | No | Yes |
| Cephalo-metricanalysis | No | No | Cephalometric view withlength and angularmeasurements and specialtools for differentcephalometric schools. |
| Implantplanning | No | Yes | Yes |
| Soft tissuesimulationand photomapping | No | No | Yes |
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.
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5 510(k) Summary for SICAT Function
Missing features of SICAT Function compared to the predicate devices are connected to implant planning, i.e. the planning feature itself and the measurement of grey values, and to the planning of orthognatic surgery, i.e. the simulation of orthodontic procedures, osteotomies and distraction, soft tissue simulation and the cephalometric analysis. This does not impact the safety and effectiveness of SICAT Function concerning the visualization and segmentation of imaging information and the evaluation of other dental treatment options.
Additional features of SICAT Function compared to the predicate devices are the import and visualization of jaw motion data. Performance testing has been used to validate the safety and effectiveness of SICAT Function related to the import and visualization of jaw motion data.
The predicate device SICAT Implant does not provide features for the segmentation of imaging information and for jaw motion data. Otherwise the software algorithms used in SICAT Function are identical to the predicate device SICAT Implant. Performance testing has been used to validate the safety and effectiveness of the SJCAT Function segmentation features in comparison to the predicate device Simplant.
7. Non-Clinical Performance Testing and Verification and Validation Activities
For SICAT Function, software verification and validation activities were performed, in accordance with the following Guidances and Standards:
- NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine . (DICOM) Set. ·
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- 510(k) Summary for SICAT Function 5
- . ISO 14971 Second edition 2007-03-01, Medical devices - Application of risk management to medical devices.
- IEC 62304 First edition 2006-05, Medical device software Software life cycle . processes.
- . ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- ◆ IEC 62366:2007, Medical devices - Application of usability engineering to medical devices
- SMPTE Recommended Practice RP 133-1991: Specifications for Medical . Diagnostic Imaging Test Pattern for Television Monitors and Hard-copy Recording Cameras
- ◆ HIPAA 45 CFR Part 160 - General Administrative Requirements
- . HIPAA 45 CFR Part 164 - Security and Privacy
- ◆ Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf .
- . Software Use in Medical Devices, Document issued on: September 9, 1999
- . Device Labeling Guidance, March 8, 1991 (G91-1)
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002
- . Guidance for Industry, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, Document issued on: January 14, 2005
- . Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management: July 18, 2000
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 correct import, registration and visualization of jaw motion data . and
- . to verify the safety and effectiveness of image segmentation features.
October 17th, 2013
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5 510(k) Summary for SICAT Function
K133320
Page 6 of 6
Test reports for integration testing, system verification testing and bench testing are included with this premarket notification.
A verification and validation activities summary report provided with this premarket notification concludes that SICAT Function 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 Function is considered to be substantially equivalent in design, material and function to the predicate devices. It is believed to perform as well as the predicate devices for the visualization and segmentation of imaging information and the evaluation of dental treatment options. Accordingly we respectfully request the Agency to find this traditional 510(k) premarket notification to be Substantially Equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three wave-like lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
SICAT GMBH & CO. KG % OLAF TEICHERT THIRD PARTY REVIEWER TUV SUD AMERICA INC. 1775 OLD HWY 8 NW, STE 104 NEW BRIGHTON MN 25112
Re: K133320
Trade/Device Name: Sicat Function Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 16, 2014 Received: January 22, 2014
Dear Mr. Teichert:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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. Teichert
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133320
Device Name Sicat Function
Indications for Use (Describe)
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Sm.h.7)
FORM FDA 3881 (1/14)
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§ 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).