coDiagnostiX is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT or DVT scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement.

For automated manufacturing of drill guides in the dental laboratory environment, the coDiagnostiX software allows for export of data to 3D manufacturing systems. Alternatively, coDiagnostiX can provide printouts of template plans for the creation of surgical templates using a manually operated gonyX table.

Device Description

coDiagnostiX Implant Planning Software is designed for diagnosis of 3dimensional datasets and precise image-guided and reproducible preoperative planning of dental implants. The software is provided in three configurations: station, client or server. Patient image data is received from various sources such as CT or DVT scanning. The scanned data will be read with the coDiagnostiX DICOM transfer module using the DICOM format, converted into 3dimensional datasets and stored in a database. Surgical planning is performed through the calculation of special views, analysis of graphic data and the placement of virtual dental implants. Additional functions are available to the user for refinement of the surgical planning, such as:

Active measurement tools, length and angle, for individual measuring of implant positions
· Nerve module to assist in distinguishing the nervus mandibularis channel
. 3D cut for a 3dimensional cut through the jaw for fine adjustment of the implant position
Segmentation module for coloring several areas inside the slice . dataset, e.g., jaw bone, natural tooth series, or types of tissue, e.g., bone, skin, and creating a 3D reconstruction for the dataset
Parallelizing function for adjustment of adjacent images ●
Bone densitometry with a density statistic for density measuring in the area around the positioned implant; a density allocation along, and transverse to, the implant cover area is displayed

All working steps are saved automatically to the patient file; one patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan. The guided surgical template plan, STL file and/or guided surgical protocol is generated from the final surgical plan.

AI/ML Overview

The provided text is a 510(k) Summary for the coDiagnostiX Implant Planning Software. It indicates that "Software verification and validation testing were performed to ensure that the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output." and "The proposed software met the acceptance criteria."

However, the document does not provide specific details regarding:

A table of acceptance criteria and the reported device performance. While it states the software met acceptance criteria, the criteria themselves and the performance metrics are not listed.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
Whether a standalone performance study (algorithm only) was done.
The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
The sample size for the training set.
How the ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence to a predicate device (K071636, IVS coDiagnostiX) based on intended use, technological characteristics, and a statement that verification and validation testing was performed. It references the "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," issued on January 11, 2002, as the guiding document for testing.

Conclusion based on the provided text:

The document states that the software met the acceptance criteria, and verification and validation testing was performed. However, it does not provide the specific details of the acceptance criteria or the study results to prove the device met these criteria. Therefore, most of the requested information cannot be extracted from this 510(k) summary.

Information that can be extracted (limited):

Acceptance Criteria Summary: The overall acceptance criterion was that "the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output."
Study Proving Acceptance: "Software verification and validation testing were performed."
Guidance followed: "Testing has been carried out in accordance with the FDA guidance document, 'General Principles of Software Validation: Final Guidance for Industry and FDA Staff,' issued on January 11, 2002."

Table of Acceptance Criteria and Reported Device Performance (Cannot be generated from the provided text):

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Details of the Study (Mostly N/A from provided text):

Sample size used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method for the test set: Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not specified. The document does not describe any human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states "Software verification and validation testing were performed," which implies standalone testing of the software's functionality, but no specific performance metrics are provided.
The type of ground truth used: Not specified.
The sample size for the training set: Not applicable, as this is a software for planning, not a machine learning model that undergoes "training" in the typical AI sense. The document describes traditional software verification and validation, not AI model development.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary

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510(k) Summary - K130724

JUN 2 8 2013

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Regulatory Project Manager

March 15, 2013 2. Date of Submission:

3. Name of the Device

Trade Name: Common Name: Classification Name: Regulation Number:

coDiagnostiX Implant Planning Software Dental 3D diagnosis and implant planning software Image Processing System 8892.2050

Legally Marketed Device to which Equivalence is Claimed (Predicate 4. Device)

K071636, IVS coDiagnostiX

5. Description of the Device

Active measurement tools, length and angle, for individual measuring of implant positions
· Nerve module to assist in distinguishing the nervus mandibularis channel
. 3D cut for a 3dimensional cut through the jaw for fine adjustment of the implant position

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Segmentation module for coloring several areas inside the slice . dataset, e.g., jaw bone, natural tooth series, or types of tissue, e.g., bone, skin, and creating a 3D reconstruction for the dataset
Parallelizing function for adjustment of adjacent images ●
Bone densitometry with a density statistic for density measuring in the area around the positioned implant; a density allocation along, and transverse to, the implant cover area is displayed

6. Intended Use of the Device

7. Technological Characteristics

coDiagnostiX Implant Planning Software is a dental image diagnosis and implant planning software. A comparison of the technological characteristics of predicate and subject device is below.

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FEATURE	PROPOSED DEVICEcoDiagnostiX	PREDICATE DEVICEIVS coDiagnostiX
K Number	Subject Submission	K071636
Intended Use	Straumann coDiagnostiX is an implantplanning and surgery planning software toolintended for use by dental practitioners withappropriate training in dental implantology.This software reads imaging informationoutput from medical scanners such as CT orDVT scanners. It allows pre-operativesimulation and evaluation of patient anatomy,dental implant placement and surgicaltreatment options.For automated manufacturing of drill guides inthe dental laboratory environment, thecoDiagnostiX software allows for export ofdata to 3D manufacturing systems, orcoDiagnostiX can provide printouts oftemplant plans for the creation of surgicaltemplates using a manually operated gonyXtable.The target patient population is the generalpublic. coDiagnostiX is not intended to beused in direct contact with the patient nor is itintended to be used with life sustainingdevices.	coDiagnostiX is intended for use bymedical trained people as a Windows-based diagnosis and implant planningsoftware. This software is an interface forthe transfer of imaging information frommedical scanners such as CT or DVTscanners and also a pre-operative softwarefor simulation and evaluation dental implantplacement and surgical treatment options.The patient population will be the generalpublic. coDiagnostiX is not intended to beused in direct contact with the patient norit intended to be used with life sustainingdevices.It is possible to use coDiagnostiX as apattern for manufacturing drilling templatewith conventional rotary tables or gonyXtable from IVS Solutions AG in laboratoryenvironment. This drilling template is thenused in direct contact with the patient torealize the implant planning withcoDiagnostiX.
MinimumSystemRequirements	OS: Microsoft Windows 7, Windows SP,VistaProcessor: Intel Core or AMD Athlon 64X2Main memory: 2 GBHard disk: 1GB free, plus 50 MB perplanScreen resolution: 1024 x 768 pixelsDVD driveOne free USB portOptional: Microsoft SQL Server DesktopEngine (MSDE) if user selects to usethe SQL Server ModuleThe software can also be run on theApple operating system with minimumsystem requirements of:Macintosh computer with IntelprocessorMac OSX 10.6 or newer"Parallels Desktop" for Macintoshincluding valid Windows license(software purchased separately)	WIN 98/NT/2000/XPPentium compatible processor with800MHz128 MB RAM500 MB hard disc17" color display with 1024x768resolution and 16.7 million colorsCD ROM deviceUSB interfaceOptional: Microsoft SQL ServerDesktop Engine (MSDE) if user selectsto use the SQL Server ModuleThe software can also be run on theApple operating system with minimumsystem requirements of:Macintosh computer with IntelprocessorMac OSX 10.6 or newer"Parallels Desktop" for Macintoshincluding valid Windows license(software purchased separately)
Target Population	Same	General public
Supported imageformats	Same	JPEG, BMP
DICOM compliant	Yes	yes
Image import	Same, plus STL file format	DICOM data from CT/DVT scannersaved on CDROM, PC or network
Image export	STL file format	unknown
Printouts	Same	Report/plan with patient information,screenshot, implant list, template

and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co

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K130724
Page 4 of 4

8. Performance Testing

Software verification and validation testing were performed to ensure that the device subject to this 510(k) Premarket Notification functions as intended and that design input matches design output. Testing has been carried out in accordance with the FDA guidance document, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," issued on January 11, 2002. The proposed software met the acceptance criteria.

க் Conclusion

coDiagnostiX Implant Planning Software has identical intended use, and operational and functional features, and level of concern as the currently cleared software. Results of the software validation indicate that the software performs as intended and that the proposed changes do not raise any new issues of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Cantral Center - WO66-G609 Silver Spring, MD 20093-0002

June 28. 2013

Straumann USA. LLC % Ms. Elaine Alan Regulatory Project Manager 60 Minuteman Road ANDOVER MA 01830

Re: K130724

Trade/Device Name: coDiagnostiX Implant Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 17, 2013 Received: May 20, 2013

Dear Ms. Alan:

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 cither 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 practive 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 - Ms. Alan

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/ResourcesforYou/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,

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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Indications for Use

510(k) Number (if known): K130724

Device Name: coDiagnostiX Implant Planning Software

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiologic Health (OIR)

Jamingh. Mesa

Division Sign-Off Office of In Vitro Diagnostics and Radiologic Health

510(k) K130724

Page 1 of 1

Regulation Number and Section

§ 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).