This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation dental implant placement and surgical treatment options.

The patient population will be the general public.

coDiagnostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

It's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiggnostiX®.

Device Description

coDiagnostiX® is designed for diagnosis of 3dimensional datasets and precise image- quided and reproducible pre- operative planning of dental implants.

The software will be provided either as station version, client or server version.

Basically, patient's medical image data from different sources like CT (computer tomography) - or DVT (Digital Volume Tomography resp. NewTom) scanner will be read in with the coDiggnostix® DICOM transfer module, transferred into 3dimensional datasets and stored in a database.

The succeeded planning is realized through the calculation of special views, the analysis of graphic data and the placement of dental implants. For assistance of the planning procedure, several functions are available:

Active measurement tools (length and angle) for individual measuring of implant positions -
Nerve module for distinguishing the behaviour of 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 kinds of tissue (e.g. bone, skin) and creating a 3D reconstruction of 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 the and transverse to the implant cover area is displayed

All working steps will be saved automatically to the actual plan of the patient. For each patient several plans are possible to generate several proposals, so that the dentist or lab is free to choose the ideal proposal for generating an according drilling template needed for realization of the planning during the main operation.

As in the station version of the coDiognostiX® software all functions are available, the client version needs the patient data provided by the server version.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for coDiagnostiX® software.

Based on the provided 510(k) summary, there is no detailed information about specific acceptance criteria or a study that quantitatively "proves" the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) Premarket Notification Summary for coDiagnostiX® software, which focuses on demonstrating substantial equivalence to predicate devices. In the context of 510(k) submissions, the primary "study" is often a comparison to legally marketed predicate devices to show that the new device has similar intended use, technological characteristics, and does not raise new questions of safety or effectiveness.

Therefore, many of the requested details about specific performance metrics, sample sizes for test sets, expert qualifications, and MRMC studies are not present in this type of regulatory document, which aims to establish substantial equivalence rather than a full, de novo performance study.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Since direct performance metrics are not provided, the "acceptance criteria" and "reported device performance" are implicitly tied to demonstrating substantial equivalence to predicate devices, which implies similar clinical utility and safety.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit from 510(k) Conclusion)
Substantial Equivalence to Predicate Devices	Determined to be substantially equivalent to SimPlant System (K033849) and Vimplant™ (K053155).
Intended Use: Dental 3D diagnosis and implant planning software	Similar intended use as predicate devices.
Operational and Functional Features	Similar operational and functional features as predicate devices (e.g., 3D data processing, implant planning, measurement tools, nerve module, bone densitometry).
No New Issues of Safety and Effectiveness	Differences between devices do not raise new issues of safety and effectiveness.
Compliance with Applicable Standards (e.g., ISO, DICOM)	Complies with ISO 9001:2000, ISO 13485:2003, ISO 14971:2001, IEC 60601-1-4:1996, 93/42/EEC, and DICOM standards.
Risk Analysis and Control	All potential hazards studied and controlled; device is of moderate level of concern as per FDA guidance.

Detailed Study Information (Based on Available Text)

1. A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria are broadly defined by the requirements for substantial equivalence in a 510(k) submission, rather than specific quantitative performance targets. The "reported device performance" is primarily the FDA's finding of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the document. This 510(k) summary does not detail a specific clinical or performance test set with a defined sample size for evaluating the device's accuracy or efficacy in a clinical setting. The focus is on technical comparison to predicate devices and adherence to standards.
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 applicable/Not specified. As no specific "test set" or "ground truth" establishment in a traditional performance study sense is described, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This pertains to clinical performance studies, which are not detailed in this 510(k) summary.
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 MRMC study mentioned. This document does not describe such a study. coDiagnostiX® is described as an image processing and planning software, not explicitly an AI-assisted diagnostic tool in the modern sense that would typically involve human reader improvement metrics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly detailed as a standalone performance study. The software is described as a "diagnosis and implant planning software" for "medical trained people," indicating it is an aid for humans, not a fully autonomous diagnostic device. Performance is implicitly demonstrated via substantial equivalence to existing human-assisted predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. No specific ground truth methodology for a performance study is described. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices to which coDiagnostiX® is compared.
8. The sample size for the training set:
- Not applicable/Not specified. This software, from 2007, likely predates the widespread use of "training sets" in the context of deep learning or machine learning for medical devices. The document does not describe any machine learning component that would necessitate a training set in this sense. If there were internal verification/validation datasets for software development, their sizes are not disclosed here.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. Similar to the above, this information is not relevant or provided given the nature of the submission and the technology described.

Summary of Device Context:

The coDiagnostiX® software (version 5.7.2) is a computer-aided tool for dental 3D diagnosis and implant planning. Its core functions involve processing 3D medical image data (CT, DVT), allowing for measurement, nerve module analysis, 3D cuts, segmentation, parallelizing functions, and bone densitometry to assist medical professionals in pre-operative planning of dental implants. It is intended for use by "medical trained people" and acts as an interface and a planning tool. The submission is a 510(k) demonstrating substantial equivalence to other legally marketed dental implant planning software (SimPlant System and Vimplant™).

Summary

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Image /page/0/Picture/0 description: The image shows a black and white graphic. The graphic appears to be a stylized representation of a human head or brain. The words "Solutions AG" are visible in the lower left corner of the image.

IVS Solutions AG

Annaberger Straße 240, 09125 Chemnitz, Germany

+49-371-5347 380 ABR 를 +49-371-5347 428

网 ivs@ivs-solutions.com (4) www.ivs-solutions.com

.ivs-solutions.com

AUG - 9 2007

5. 510(k) Summary of Safety and Effectiveness

K071636

5.1. Submitter

IVS Solutions AG Annaberger Strasse 240 D- 09125 Chemnitz, GERMANY E- Mail: ivs@ivs-solutions.com

5.2. Official Correspondent

Mr. Frank Stockmann, Chief Executive Officer IVS Solutions AG Annaberger Strasse 240 D- 09125 Chemnitz, Germany Phone: +49- 371- 5347 380 Fax: +49- 371- 5347 428 E- Mail: f.stockmann@ivs-solutions.com

5.3. Date of submission

05/24/2007

5.4. Device Information

Trade name: coDiagnostiX® Version: 5.7.2 Common Name: Dental 3D diagnosis and implant planning software Device Class: Class II Classification name: Image Processing System Classification Panel: Radiology Classification number: 21 CFR 892.2050 Product Code: LLZ

5.5. Predicate Device(s)

	Predicate #1	Predicate #2
Manufacturer	MATERIALIZE N.V.	CyberMed, Inc.
Trade Name	SimPlant System	Vimplant™
510(k) Number	K033849	K053155
Regulation Number	892.2050	892.2050
Product Code	LLZ	LLZ

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Image /page/1/Picture/0 description: The image shows a black and white graphic of a human head in profile. The head is facing right, and the details of the face and head are somewhat obscured, giving it an abstract appearance. Below the head, the text "Solutions AG" is visible in a contrasting color, likely white or a light shade, against the dark background.

IVS Solutions AG

naberger Straße 240, 09125 Chemnitz, Germany

9-371-5347 380 49-371-5347 428

ivs@ivs-solutions.com www.ivs-solutions.com

5.6. Device Description

coDiagnostiX® is designed for diagnosis of 3dimensional datasets and precise image- quided and reproducible pre- operative planning of dental implants.

The software will be provided either as station version, client or server version.

Active measurement tools (length and angle) for individual measuring of implant positions -
Nerve module for distinguishing the behaviour of 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 kinds of tissue (e.g. bone, skin) and creating a 3D reconstruction of 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 the and transverse to the implant cover area is displayed

As in the station version of the coDiognostiX® software all functions are available, the client version needs the patient data provided by the server version.

5.7. Intended Use

coDiagnostiX® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software.

The patient population will be the general public.

coDiognostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

lt's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiggnostiX®.

5.8. Applicable mandatory and voluntary standards

coDiognostix® complies with the following mandatory and voluntary standards:

ISO 9001:2000 Quality management systems 1
ISO 13485:2003 Quality management systems, requirements for regulatory purposes -
ISO 14971:2001 Application of risk management to medical devices -
IEC 60601-1-4:1996 + A1:1999 Medical electrical equipment Part 1-4: General requirements -

for safety; Collateral standard: Programmable electrical medical systems

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Image /page/2/Picture/0 description: The image is a black and white graphic. The graphic appears to be a head or skull. At the bottom of the image, the text "Solutions AG" is visible.

IVS Solutions AG Annaberger Straße 240, 09125 Chemnitz, Germany

49-371-5347 380 +49-371-5347 428

ivs@ivs-solutions.com www.ivs-solutions.com

93/42/EEC Medical Device Directive
-DICOM (Digital Imaging and Communications in Medicine) -The standard protocol to exchange and transfer the data acquired by Medical Image Devices; developed by the American College of Radiology and the National Electrical Manufacturers Association (ACR- NEMA).
.
. JPG/ JPEG (Joint Photographic Experts Group) -A compression technique that is designed to compress color and greyscale continuous- tone images reversible and irreversible.

5.9. Technological Characteristics

coDiagnostiX® is a dental image diagnosis and implant planning software, designed to run on industrial standard PC platforms with the following minimum system requirements:

WIN 98/NT/2000/XP -
Pentium compatible Processor with 800MHz -
. 128 MB RAM
-500 MB hard disc
. 17" color display with 1024x768 resolution and 16.7 Million colors
-CD- ROM device
-USB interface.

The software will be delivered on CD with a hardware copy protection (eToken- Dongle). If the user wants to work with coDiagnostix®, the Dongle has to be connected to the PC via USB interface. In addition coDiognostiX® is designed for:

utilization of the DICOM 3.0 standard to acquire images from network or CD- ROM -
supporting standard image file formats for storage and retrieval of images (DICOM, JPEG, BMP, TIFF)
importing and exporting images
. 3D image reconstruction
image- quided implant planning
nerve creation and displaying
collision detection
printing images, image sets, implant list, drilling template plan

5.10. Safety Information

coDiagnostX® is a software product that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices.

All potential hazards have been studied and controlled as part of the product development process according to written procedures, including risk analysis, test and design considerations, verification and validation testing processes. The results of the hazard analysis indicate that the device is of moderate level of concern as per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

5.11. Conclusion

coDiagnostiX® has similar intended use, operational and functional features as the predicate devices. Any differences between the devices do not raise new issues of safety and effectiveness. That indicates, that coDiggnostiX® is substantially equivalent to and performs as good as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. The text is centered in the image.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 9 2007

Mr. Frank Stockmann Chief Executive Officer IVS Solutions AG Annaberger Strasse 240 Chemnitz, Saxony 09125 GERMANY

Re: K071636

Trade/Device Name: coDiagnostix® Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 24, 2007 Received: June 15, 2007

Dear Mr. Stockmann:

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 (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is a large, bold "PA" and the word "Centennial" underneath. The letters "USA" are at the bottom of the logo. The logo appears to be a centennial celebration emblem, possibly for an organization or event.

Protecting and Promoting Public Health

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Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows a black and white graphic of a brain inside of a skull. The brain is highly detailed with many curves and lines. The skull is also detailed, with the eye socket and nasal cavity clearly visible. At the bottom of the image, the text "Solutions AG" is visible.

IVS Solutions AG

Annaberger Straße 240, 09125 Chemnitz, Germany +49-371-5347 380 ivs@ivs-solutions.com X +49-371-5347 428

www.ivs-solutions.com

4. Indications for Use Statement

510(k) Number (if known):	K071636
Device Name:	coDiagnostiX®

Indications for Use:

coDiagnostix® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software.

The patient population will be the general public.

coDiagnostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helus Remen

Division Sign-Off)
ivision of Reproductive, Abdominal,
and Radiological Devices K071636
10(k) Number

Page 1 of 1

coDiagnostiX_510(k)_ Premarket Notification.doc

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).