(90 days)
The NobelClinician software is a software interface for the transfer and visualization of imaging information from equipment such as a CT scanner or a magnetic resonance scanner for the purposes of diagnosis and treatment planning in the dental and cranio-maxillofacial regions. The NobelClinician software can be used to design a surgical template for the purposes of aiding placement of dental implants.
NobelClinician is a software interface for the transfer and visualization of imaging information: 3D imaging like medical or Cone Beam CT data, 2D imaging like photographic images and X-ray images. NobelClinician is used to support diagnostics and treatment planning for dental and cranio-maxillofacial treatment through the use of prosthetic-driven implant planning based on the digitized patient data and the scanned radiographic guide representing the ideal diagnostic tooth setup. The planning can be previewed using the software and a surgical template realizing the planning can be ordered.
The provided 510(k) summary for NobelClinician (K123976) does not contain detailed information regarding specific acceptance criteria for a device performance study or the results of such a study in a quantitative manner (e.g., sensitivity, specificity, accuracy).
Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices through a qualitative comparison of features, intended use, and indications for use.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not include a table of acceptance criteria or quantitative device performance metrics (e.g., sensitivity, specificity, accuracy, dice score, etc.). The "Summary of testing to demonstrate safety and effectiveness" section states: "The performance of the NobelClinician software was verified and validated following the guidance provided in Guidance for the Content of Premarket Submissions for Software in Medical Devices." This indicates that verification and validation activities were performed, but the specific acceptance criteria and the results demonstrating meeting those criteria are not detailed in this 510(k) summary. The submission focuses on qualitative comparisons to predicates.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective or prospective data). The V&V activities likely involved internal testing rather than a clinical study with a defined test set of patient data, at least not in a way that would be summarized with these details in this type of 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the number of experts used to establish ground truth or their qualifications. Given the nature of the submission (substantial equivalence through feature comparison), a formal ground truth establishment process by external experts for a novel performance claim is not indicated.
4. Adjudication Method for the Test Set
No details on an adjudication method are provided, as a formal test set with ground truth established by experts is not described in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is not mentioned or described. The submission does not claim to improve human reader performance with AI assistance. The device is software for visualization and planning, not an AI-powered diagnostic aid that would typically warrant such a study.
6. Standalone Performance Study
A standalone performance study (algorithm only performance without human-in-the-loop) is not explicitly detailed with quantitative metrics. The V&V activities likely included internal functional and performance testing, but the results are not presented in a traditional standalone performance study format in this summary.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. For a dental/cranio-maxillofacial planning software, ground truth for verification and validation would likely involve:
- Engineering specifications/measurements: Comparing software output (e.g., measurements, implant placement coordinates) against known inputs or manually verified measurements.
- Expert consensus (implicit): Clinical validation of planning by dental professionals, though not described as a formal ground truth establishment process for a performance study in this summary.
- Predicate device comparison: Functional and performance equivalence to the predicate devices.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This device is described as a "software interface for the transfer and visualization of imaging information" and a "planning software." It's not explicitly presented as an AI/machine learning device that would require a distinct training set in the modern sense. The "training" in this context would more likely refer to the iterative development and internal testing of the software.
9. How Ground Truth for the Training Set Was Established
As no training set is discussed in the context of machine learning, no information on how its "ground truth" was established is provided.
In summary, the 510(k) K123976 primarily relies on demonstrating substantial equivalence through a feature-by-feature comparison with legally marketed predicate devices, rather than presenting a detailed device performance study with specific acceptance criteria and quantitative results from a clinical test set. The statement about "verified and validated following the guidance" indicates that internal testing was done, but the specific metrics and methodology are not part of this public summary.
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K123976
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510(k) Summary of Safety and Effectiveness 1.4
26 2013
| Submitted by: | Phuong NguyenManager Regulatory Affairs | DATE | Clinician | PREDICATEThe Guided Surgery Concept(K050393) | PREDICATESwissmeda Dental PlanningSystem(K112251) | PREDICATEMaxilim(K052424) |
|---|---|---|---|---|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 | atient | DICOM- Help assistant- Create a new patient record- Create and manage planning scenarios and treatments- Create and edit 3D Models- Create a snapshot of a viewer | DICOM- Create a new patient record- Create and edit 3D Models | DICOM- Help assistant- Create a new patient record- Add images to a patient- Create and manage planning scenarios and treatments- Create and edit 3D Models- Create a snapshot of a viewer | |
| Telephone: | (714) 282-4800 x7830 | a patientnagerios and | - Display and manipulate reslices | - Display and manipulate reslices | - Display and manipulate reslices | |
| Facsimile: | (714) 998-9348 | 3D Modelshot of a | - Define the dental curve shape | - Define the dental curve shape- Define a new visualization for the volume model | - Annotate structures | |
| Date of Submission: | December 21, 2012 | anipulate | - Adding prosthetics information | - Adding prosthetics information | - Diagnostic 3D visualisation for diagnostics of maxillofacial anatomy | |
| Classification Name: | System, Image Processing System, Radiology (21 CFR 892.2050) | cal curve | - Alignment of radiographic guide and patient model | - Alignment of radiographic guide and patient model- Indicate and edit nerve structures | - Measure the distance between 2 points | |
| Trade or Proprietaryor Model Name: | NobelClinician | isualizationmodel | - Annotate structures | - Adding an implant to a planning and edit | - Warning system | |
| Legally Marketed Device(s): | Swissmeda Dental Planning System (K112251)The Guided Surgery Concept (K050393)Maxilim (K052424) | ticsdiographicent model | - Measure the distance between 2 points | - Adding an abutment to an implant | ||
| uresvisualisationofatomystancets | - Measure the plane angle between 2 points- Indicate and edit nerve structures- Adding an implant to a planning and edit | - Manage objects in a 2D and 3D viewer- Surgical template visualization- Approve function- Create and send an order |
Device Description:
NobelClinician is a software interface for the transfer and visualization of imaging information: 3D imaging like medical or Cone Beam CT data, 2D imaging like photographic images and X-ray images. NobelClinician is used to support diagnostics and treatment planning for dental and cranio-maxillofacial treatment through the use of prosthetic-driven implant planning based on the digitized patient data and the scanned radiographic guide representing the ideal diagnostic tooth setup. The planning can be previewed using the software and a surgical template realizing the planning can be ordered.
Indications for Use:
The NobelClinician software interface for the transfer and visualization of imaging information from equipment such as a CT scanner or a magnetic resonance scanner for the purposes of diagnosis and treatment planning in the dental and cranio-maxillofacial regions. The NobelClinician software can be used to design a surgical template for the purposes of aiding placement of dental implants.
Summary of testing to demonstrate safety and effectiveness:
The performance of the NobelClinician software was verified and validated following the guidance provided in Guidance for the Content of Premarket Submissions for Software in Medical Devices.
Conclusions:
The information provided in this submission demonstrates that NobelClinician is substantially equivalent to the predicate device.
Nobel Biocare Traditional 510(k) Notification NobelClinician December 2012
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Substantial Equivalence Comparison to Predicate Devices
510(k) Summary of Safety and Effectivenes
1.4
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
K123976
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| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
|---|---|---|---|---|
| NobelClinician | The Guided Surgery Concept (K050393) | Swissmeda Dental Planning System (K112251) | Maxilim (K052424) | |
| - Adding an abutment to an implant- Manage objects in a 2D and 3D viewer- Warning system- Surgical template visualization- Approve function- Create and send an order | ||||
| Intended use | - Measure the plane angle between 2 points- Indicate and edit nerve structures- Adding an implant to a planning and edit- Adding an abutment to an implant- Manage objects in a 2D and 3D viewer- Warning system- Surgical template visualization- Approve function- Create and send an order- Diagnostics- Surgical planning for dental implants- Creation of surgical template | - Diagnostics- Surgical planning for dental implants- Creation of surgical template | - Diagnostics- Surgical planning for dental implants- Creation of surgical template | - Diagnostics- Surgical planning for dental implants- Creation of surgical template |
| Computer format | PC - Windows basedMAC - OS | PC - Windows based | PC - Windows based | PC - Windows based |
| Anatomic areas | MaxillaMandibleCranio-maxillofacial | MaxillaMandible | MaxillaMandible | MaxillaMandibleCranio-maxillofacial |
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
| Indications for Use | NobelClinicianThe NobelClinician software isa software interface for thetransfer and visualization ofimaging information fromequipment such as a CTscanner or a magneticresonance scanner for thepurposes of diagnosis andtreatment planning in the dentaland cranio-maxillofacialregions. The NobelCliniciansoftware can be used to designa surgical template for thepurposes of aiding placementof dental implants. | The Guided Surgery Concept(K050393)The Guided Surgery Conceptand Teeth-in-an-Hour areindicated for the treatment ofsingle, partially and totallyedentulous jaws for placementof implant fixtures withimmediate function to restorepatient esthetics and chewingfunction. The followingprerequisites must be fulfilled:- Adequate amount of jawbone- The quality of jaw bone mustbe judged as adequate | Swissmeda Dental PlanningSystem(K112251)Swissmeda Dental PlanningSystem is intended for use byqualified dental professionalsfor Windows based diagnosticsand implant planning.The software is an interface forimaging data that originatesfrom medical scanners such asCT or DVT scanners and it isalso a pre-operative softwarefor simulation and evaluation ofdental implant placement in thepatient's mandible/maxilla andfor surgical treatment options.Swissmeda Implant PlanningSystem is not intended to beused in direct contact with thepatient nor is it intended to beused with life sustainingdevices. | Maxilim(K052424)Maxilim is indicated for use as asoftware interface and imagesegmentation system for thetransfer of imaging informationfrom a medical scanner such asa CT scanner. It is alsoindicated for use as a planningan simulation software forsurgical treatment, specificallymaxillofacial treatment. |
| The planning data may beexported from SwissmedaDental Planning System andused as input data for a specialdrilling device from companyGeorg Schick for manufacturing | ||||
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
| NobelClinician | The Guided Surgery Concept(K050393) | Swissmeda Dental PlanningSystem(K112251) | Maxilim(K052424) | |
| drillingtemplates in a laboratoryenvironment. The drillingtemplate is then used in directcontact with the patient torealize the implant planning. |
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
K123976
Page 3 of 5
Substantial Equivalence Comparison to Predicate Devices
510(k) Summary of Safety and Effectiveness
1.4
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510(k) Summary of Safety and Effectiveness 1.4
Substantial Equivalence Comparison to Predicate Devices
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
<123976
Page 4 of 5
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510(k) Summary of Safety and Effectiveness 1.4
·
Substantial Equivalence Comparison to Predicate Devices
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
:
K123976
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2013
Nobel Biocare USA, LLC % Mr. Phuong Nguyen Manager Regulatory Affairs 22715 Savi Ranch Parkway YORBA LINDA CA 92887
Re: K123976
Trade/Device Name: NobelClinician Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 21, 2012 Received: December 26, 2012
Dear Mr. Nguyen:
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 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. Phuong Nguyen
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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,
Smh.7)
for
Janine 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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Indications for Use
510(k) Number K123976
Device Name: NobelClinician
Indications For Use:
The NobelClinician software is a software interface for the transfer and visualization of imaging information from equipment such as a CT scanner or a magnetic resonance scanner for the purposes of diagnosis and treatment planning in the dental and craniomaxillofacial regions. The NobelClinician software can be used to design a surgical template for the purposes of aiding placement of dental implants.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.P.)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) 123976
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).