(236 days)
Not Found
No
The document describes standard medical imaging processing and 3D modeling for surgical planning and guide design. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The accuracy metrics are based on geometric measurements and standard image processing techniques, not AI/ML model performance.
No.
This device is a software for planning dental implant placement and designing surgical guides, not a device that directly treats a medical condition or disease.
No
This device is intended for planning dental implant placement and designing surgical guides, based on CT/CBCT data. While it uses diagnostic data, its function is for planning and design, not for making a diagnosis.
Yes
The device is explicitly described as a "standalone software application" and runs on "off-the-shelf" PC hardware. It does not include any proprietary hardware components.
Based on the provided information, exoplan is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, or other bodily fluids.
- exoplan's intended use is for planning dental implant placement and designing surgical guides. It uses medical imaging data (CT/CBCT and optical scans) of the patient's anatomy to visualize and plan a surgical procedure. It does not perform any tests on biological specimens.
- The software's function is to support a surgical procedure by providing planning and design tools. It is a pre-operative tool that aids the dental professional in preparing for the surgery, not in diagnosing a condition or monitoring a patient's health through laboratory analysis.
In summary, exoplan is a medical device software used for surgical planning and guide design, which falls under a different regulatory category than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
exoplan is a medical software, intended to support the planning of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal.
exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representive situation and approved implant positions. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.
The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system (7, 8.1,10, 64 Bit), off-the shell GPU card and otherwise standard peripheral components.
The device allows importing 3D CT data and dental scan data (e.g. scans from teeth, dental impression, or stone models) from compatible intraoral or desktop scanners. While the planning of implant position is mainly based on the information of the CT data, the design of a surgical quide is based on the STL data of the dental scan. Both modalities are registered to a common coordinate system to ensure that the implant positions defined by a user can be used for design of a surgical guide.
exoplan uses so called Implant Libraries that contain information provided by the original manufacturer of a respective physical implant, reconstruction parts on top of the implant, such as stock abutments or titanium bases. Libraries also contain drilling sleeves and tools of surgical kit items, such as drills and drill handles. The libraries are digitally signed and by that any modification of a library content or the referred library parts of files will be detected by exoplan reported to the user and documented in an Implant Planning Report or Surgical Protocol document.
exoplan has no contact with the patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/CBCT data sets, optical scan(s)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: Software verification and validation is performed in accordance with the applicable quidance document ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005). Prior to release of exoplan the verification and validation of the device has been completed. Each user requirement and each product requirement derived thereof has an own acceptance criteria. Detected anomalies are evaluated, resolved or where appropriate in case of a minor issue described in the release notes. The verification and validation includes the verification and where appropriate validation of the risk mitiqation measure as defined by the risk analysis. Feedback of software testers and feedback from validation is regarded in the device as appropriate.
Accuracy Results:
- Visualization of iso-surface of CT data accuracy: accuracy of visualization of 3D CT data is 10% of the maximum voxel size (voxel size: 1mm, therefore accuracy 0.1mm)
- Density threshold accuracy in 3D CT data: visualization accuracy for a perfectly selected threshold is 10% of maximum voxel size.
- Accuracy of distance measurement in 3D CT data, rendering modes "iso-surface", "solid": In general, dimensional measurement has an accuracy of 0.01mm. Clicking on DICOM object in iso-surface or solid rendering mode has an additional limitation of 10% of the voxel size
- Accuracy of distance measurement in STL meshes: Achievable accuracy of dimensional measurements in mesh data: 0.01mm
- Accuracy of angle measurement: achievable accuracy of measurement of angles in mesh data: 0.5°
- CT Data alignment accuracy, 3 Point Alignment & Best Fit Alignment: 3 Point Alignment, achievable accuracy: 1mm. Best Fit Alignment, in general the achievable accuracy depends on the resolution of the input data. For this data set the achievable accuracy is 0.2mm
- Implant placement accuracy: Achievable accuracy of 0.3 mm relative to CT data
- Collision detection accuracy, visual: Collisions are detected: Implant/implant, marked nerve/implant, collision object mesh/implant
- Collision detection accuracy: 0.01mm
- Drill Sleeve placement accuracy: Accuracy of placing a sleeve along the implant axis: 0.01mm
- Drill Sleeve rotation accuracy: Achievable repetitious accuracy of 1°
- Accuracy of Surgical Guide bottom: Accuracy of the surgical guide bottom to the optical scan data plus the user defined offset is 0.1mm in smooth areas without undercuts
- Accuracy of merged Surgical Guide parts: Accuracy of the surgical guide individual parts to the surface of the merged parts is 0.01mm in smooth areas
- Accuracy of merged Surgical Guide bottom: Accuracy of the surgical guide bottom to the surface of the merged bottom is 0.01mm in smooth areas
Clinical: Clinical testing is not a requirement and has not been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 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 the FDA logo, which 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.
August 6, 2019
exocad GmbH % Mr. Stefan Walter Quality Manager 37, Julius-Reiber-Str. Darmstadt, Hessen 64293 GERMANY
Re: K183458
Trade/Device Name: exoplan 2.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 25, 2019 Received: July 3, 2019
Dear Mr. Walter:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183458
Device Name
exoplan 2.3
Indications for Use (Describe)
exoplan is a medical software, intended to support the planning of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal.
exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representive situation and approved implant positions. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of 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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3
510(k) Summary, Traditional 510(k)
K183458
Submitter Information
exocad GmbH 37 Julius-Reiber-Strasse Darmstadt, HE 64293 Germany Contact Person: Stefan Walter, Quality Manager Phone: +49-6151-629489-0 fax: +49 6151-629489-9
Establishment Registration number: 3011521456
Date prepared: 2019-08-05
Manufacturing Facility
Same as submitter.
Device Information
| Trade/proprietary Name: | exoplan 2.3 |
|---|---|
| Common Name/Usual name: | Dental Implant Planning and tooth retained Surgical Guide |
| design software application | |
| Device Classification Name: | Picture archiving and communications system |
| Regulation Number: | 892.2050 |
| Classification: | Class II |
| Classification Product Code: | LLZ |
Predicate Device
exoplan has been compared to the following predicate legally marketed device:
| 510(k) Number: | K152078 |
|---|---|
| Predicate device: | Implant Studio™ 2015 |
| Manufacturer: | 3Shape A/S, Holmens Kanal 7, DK-1060 Copenhagen K |
Intended Use
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal.
exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
4
Device Description & Summary of Technical Characteristics
exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.
The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system (7, 8.1,10, 64 Bit), off-the shell GPU card and otherwise standard peripheral components.
The device allows importing 3D CT data and dental scan data (e.g. scans from teeth, dental impression, or stone models) from compatible intraoral or desktop scanners. While the planning of implant position is mainly based on the information of the CT data, the design of a surgical quide is based on the STL data of the dental scan. Both modalities are registered to a common coordinate system to ensure that the implant positions defined by a user can be used for design of a surgical guide.
exoplan uses so called Implant Libraries that contain information provided by the original manufacturer of a respective physical implant, reconstruction parts on top of the implant, such as stock abutments or titanium bases. Libraries also contain drilling sleeves and tools of surgical kit items, such as drills and drill handles. The libraries are digitally signed and by that any modification of a library content or the referred library parts of files will be detected by exoplan reported to the user and documented in an Implant Planning Report or Surgical Protocol document.
exoplan has no contact with the patient.
Note! In the US, the physical surgical guide for endosseous dental implant placement is a medical device to be manufactured at an FDA reqistered and listed manufacturing location.
Non-clinical Testing
Software verification and validation is performed in accordance with the applicable quidance document ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005). Prior to release of exoplan the verification and validation of the device has been completed. Each user requirement and each product requirement derived thereof has an own acceptance criteria. Detected anomalies are evaluated, resolved or where appropriate in case of a minor issue described in the release notes. The verification and validation includes the verification and where appropriate validation of the risk mitiqation measure as defined by the risk analysis. Feedback of software testers and feedback from validation is regarded in the device as appropriate.
Summary of tests and accuracy results
This section lists several tests that verify important accuracies in various working steps in the exoplan workflow as can be achieved with the exoplan software. The selected tests verify accuracies of critical items in the whole workflow of exoplan:
- 3D CT data visualization accuracy -
- -Density threshold accuracy
- -Measurement accuracy
- CT data to optical scan data alignment accuracy -
- lmplant placement accuracy
- -Collision detection accuracy
- -Sleeve placement accuracy
- Rotation marker accuracy -
- -Accuracy of surgical guide bottom compared to jaw scan
- -Accuracy of merged output compared to individual parts (mount, surgical guide top)
- Accuracy of merged surgical guide fit on surgical guide bottom
The following table provides an overview on the tests above and the achieved accuracy.
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exoplan 510(k) Summary
Image /page/5/Picture/1 description: The image shows the word "exocad" in a bold, sans-serif font. The color of the text is a dark purple. The word is positioned horizontally in the image. There is a horizontal purple line below the word.
| # | Tested Accuracy | Result |
|---|---|---|
| 3D CT data visualization accuracy | ||
| 1. | Visualization of iso-surface of CT data accuracy | accuracy of visualization of 3D CT data is 10% of the maximum voxel |
| size (voxel size: 1mm, therefore accuracy 0.1mm) | ||
| Density threshold accuracy | ||
| 2. | Density threshold accuracy in 3D CT data | visualization accuracy for a perfectly selected threshold is 10% of |
| maximum voxel size. | ||
| Measurement accuracy | ||
| 3. | Accuracy of distance measurement in 3D CT data, | |
| rendering modes "iso-surface", "solid" | In general, dimensional measurement has an accuracy of 0.01mm. | |
| Clicking on DICOM object in iso-surface or solid rendering mode has an | ||
| additional limitation of 10% of the voxel size | ||
| 4. | Accuracy of distance measurement in STL meshes | Achievable accuracy of dimensional measurements in mesh data: |
| 0.01mm | ||
| 5. | Accuracy of angle measurement | achievable accuracy of measurement of angles in mesh data: 0.5° |
| CT data to optical scan data alignment accuracy | ||
| 6. | CT Data alignment accuracy, 3 Point Alignment & | |
| Best Fit Alignment | 3 Point Alignment, achievable accuracy: 1mm | |
| Best Fit Alignment, in general the achievable accuracy depends on the | ||
| resolution of the input data. For this data set the achievable accuracy is | ||
| 0.2mm | ||
| Implant placement accuracy | ||
| 7. | Implant placement accuracy | Achievable accuracy of 0.3 mm relative to CT data |
| Collision detection accuracy | ||
| 8. | Collision detection accuracy, visual | Collisions are detected: |
| Implant/implant, marked nerve/implant, collision object mesh/implant | ||
| 9. | Collision detection accuracy | Collision detection accuracy: 0.01mm |
| Sleeve placement accuracy | ||
| 10. | Drill Sleeve placement accuracy, | Accuracy of placing a sleeve along the implant axis: 0.01mm |
| Rotation marker accuracy | ||
| 11. | Drill Sleeve rotation accuracy, | Achievable repetitious accuracy of 1° |
| Accuracy of surgical guide bottom compared to jaw scan | ||
| 12 | Accuracy of Surgical Guide bottom, | Accuracy of the surgical guide bottom to the optical scan data plus the |
| user defined offset is 0.1mm in smooth areas without undercuts | ||
| Accuracy of merged output compared to individual parts (mount, surgical guide top) | ||
| 13. | Accuracy of merged Surgical Guide parts | Accuracy of the surgical guide individual parts to the surface of the |
| merged parts is 0.01mm in smooth areas | ||
| Accuracy of merged surgical guide fit on surgical guide bottom | ||
| 14 | Accuracy of merged Surgical Guide bottom, | Accuracy of the surgical guide bottom to the surface of the merged |
| bottom is 0.01mm in smooth areas |
Clinical
Clinical testing is not a requirement and has not been performed.
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Comparative information on Predicate Device
exoplan has been compared to the following legally marketed predicate device:
510(k) Number: K152078
Implant Studio™ 2015 Predicate device:
The following tables provides a comparison of the predicate device with exoplan.
| Comparable
| Criteria | Predicate device | Device under evaluation | Eval. |
|---|---|---|---|
| Trade/ | |||
| proprietary | |||
| Name, 510(k) #: | K152078, Implant Studio™ 2015 | exoplan | --- |
| Device | |||
| Classification | |||
| Name: | Picture archiving and communications | ||
| system | Picture archiving and communications system | Identical | |
| Regulation | |||
| Number: | 892.2050 | 892.2050 | Identical |
| Classification: | Class II | Class II | Identical |
| Product Code: | LLZ | LLZ | Identical |
| Prescription/ | |||
| over the counter | |||
| use | Prescription use | Prescription use | Identical |
| Intended use / | |||
| indications / | |||
| description | Implant Studio™ is indicated for use as | ||
| medical front-end software that can be | |||
| used by medically trained professionals | |||
| for the purpose of visualizing gray value | |||
| images. It is intended for use as pre- | |||
| operative planning software for the | |||
| placement of dental implant(s) based on | |||
| imported CT image data, optionally | |||
| aligned to an optical 3D surface scan. | |||
| Virtual Crowns can be used for | |||
| optimized implant positioning under the | |||
| prosthetic aspect. The digital three | |||
| dimensional model of a surgical guide | |||
| for a guided surgery can be designed | |||
| based on the approved implant position. | |||
| This 3D data can be exported to | |||
| manufacture a separate physical | |||
| product. Indications of the dental | |||
| implants do not change with guided | |||
| surgery compared to conventional | |||
| surgery. Use of the software requires | |||
| that the user has the necessary medical | |||
| training in implantology and surgical | |||
| dentistry. | exoplan is a medical software, intended to support the pre- | ||
| operative planning of dental implants using the visualization of | |||
| the implant placement within images of the patient's anatomy. | |||
| The process is based on CT/CBCT data sets originating from | |||
| other medical devices, and can be supported by optical scan(s) | |||
| of the patient's anatomy as well as a virtual prosthetic proposal. | |||
| exoplan allows the design of surgical guides to support the | |||
| placement of endosseous dental implants in guided surgery. The | |||
| design of surgical guides is based on 3D surface data | |||
| representing the preoperative situation and approved implant | |||
| positions. The software exports the planning and design results | |||
| as geometrical data and a digital 3D model of the surgical guide | |||
| to support the manufacture of a separate physical product. | |||
| exoplan does not extend or change indications of dental | |||
| implants. Usage of a surgical guide designed with the software | |||
| does not change the necessary due diligence required compared | |||
| to conventional (non-guided) surgery. | |||
| The software is intended to be used only by dental professionals | |||
| with sufficient medical training in dental implantology and | |||
| surgical dentistry in office environments suitable for reading | |||
| diagnostic dental DICOM data sets. exoplan shall not be used | |||
| for any purpose other than planning dental implant placement or | |||
| design of surgical guides. | Equivalent | ||
| Users | necessary medical training in | ||
| implantology and surgical dentistry | dental professionals with sufficient medical training in dental | ||
| implantology and surgical dentistry | Equivalent | ||
| Input data | CT image data and | ||
| optical surface scan | CT image data and | ||
| optical surface scan | Identical | ||
| Registration / | |||
| Alignment | Registration / Alignment of CT image | ||
| data and optical surface scan | Registration / Alignment of CT image data and | ||
| optical surface scan | Identical | ||
| Output data | surgical report, drill protocol is provided, | ||
| STL file with designed guide for | |||
| manufacturing | Implant planning report, surgical protocol, STL file with designed | ||
| guide for manufacturing | Equivalent | ||
| Handling of risk | |||
| structures | Definition of mandibular nerve canal, | ||
| collision detection with implant during | |||
| implant planning | Definition of mandibular nerve canal, collision detection with | ||
| implant during implant planning | Equivalent | ||
| Surgical guide | |||
| manufacturing | Transfer to a manufacturing site. | Transfer to a manufacturing site. | Identical |
| Hardware | Any compatible of-the shelf PC, GPU, | ||
| monitor and network connection | Any compatible off-the-shelf PC with a dedicated GPU, monitor | ||
| and network connection | Identical | ||
| Gui OS | Windows ® 7, 8.1, 10 ; 32 and 64 bit | ||
| Operating System | Windows ® 7, 8.1, 10 ; 64 bit Operating System | Equivalent |
© 2019 exoplan 510(k) Summary, revision 2019-08-05, 007_exoplan_510k_Summary.docx
7
Based on the comparison of intended use, principles of operation, features, characteristics, technical data and results of the verification and validation, we conclude that exoplan is substantially equivalent to the predicate device 3Shape, Implant Studio™ 2015, and therefore safe to use as intended.