The software is an interface for imaging data that originates from medical scanners such as CT or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options.

Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

The planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning.

Device Description

Swissmeda Dental Planning System is a stand-alone software device.

It is a Windows® based software application for the visualization of imaging information of the patient's mandible/maxilla region. It is intended to be used for diagnostics and a precise and reproducible pre-operative planning of dental implants and surgical treatment by aid qualified dental professionals.

Imaging data from medical scanners such as CT or DVT scanners (DICOM Standard) will be read in. The software calculates a volumetric (3 dimensional) data set which will be displayed in different windows: One shows the data as volume data where every voxel of the data set is shown with a grey value that defines the density of the bone substance. Three other windows show a slice through the 3d data set as a flat image. During a planning session the data can be stored to pause the planning session and can be reloaded to continue the planning session.

By inspection of the 3d information of the bone the dental professional can deduct hints where to place what kind of implants. To support planning the user is enabled to predefine a dental occlusion spline and an occlusion plane. He can select implants from a given implant catalog and insert them into the 3d data set at the predefined position given by the dental spline and the tooth number. The implant catalog contains real geometry of several implants from several different vendors. Swissmeda Dental Planning System has no limitations regarding material or surface types of implants.

For each patient several versions of the plan can be created, restored and exported each time.

The final planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick Dental GmbH* for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning during the surgery.

AI/ML Overview

The provided text is a 510(k) K112251 submission for the Swissmeda Dental Planning System. This document focuses on establishing substantial equivalence to a predicate device based on intended use, features, and technological characteristics. It does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.

The document states, "The Swissmeda Dental Planning System is substantially equivalent to and performs as good as the predicate device coDiagnostiX® (K071636) based on the equivalence of the intended use, similar features and technological characteristics. Any differences between the devices do not raise new issues of safety and effectiveness." This implies that the 'study' for this submission is a comparison to a predicate device, rather than a de novo clinical trial with specific performance metrics defined by acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document as it relates to a different type of validation process.

However, I can extract the following based on the information provided:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as performance metrics in this document. The primary acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate device, coDiagnostiX® (K071636).
Reported Device Performance: The document claims the device "performs as good as the predicate device" based on "equivalence of the intended use, similar features and technological characteristics." No quantitative performance metrics like accuracy, sensitivity, or specificity are reported.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate	Substantially Equivalent (K071636), performs as good.
Similar Intended Use	Equivalent to predicate.
Similar Features	Similar features to predicate.
Similar Technological Characteristics	Similar technological characteristics to predicate.
No New Issues of Safety and Effectiveness	Differences do not raise new issues of safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable/not provided. This submission does not describe a clinical performance study with a test set of patient data. The evaluation is based on a comparison to a predicate device's features and intended use.
Data Provenance: Not applicable/not provided.

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 provided. No ground truth establishment for a test set is described in this substantial equivalence submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not provided. No test set or adjudication is described.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a "Dental Planning System," not an AI-assisted diagnostic tool for human readers in the typical sense of MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as a "stand-alone software device" intended for use by "qualified dental professionals." While it operates independently in terms of processing imaging data, its output is for professional planning, implying human-in-the-loop decision making. However, no "standalone performance" study in the sense of a medical diagnostic algorithm's accuracy without a human is reported for this device's specific function (planning). The submission focuses on device features and equivalency.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/not provided. No clinical ground truth is established for a specific study in this document.

8. The sample size for the training set

Not applicable/not provided. The document does not describe a machine learning algorithm that requires a training set. It is a software system for visualization and planning.

9. How the ground truth for the training set was established

Not applicable/not provided. As no training set is mentioned, no ground truth establishment for it is relevant.

Summary

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K112251

JAN 2 5 2012

5. 510(k) Summary

5.1 Submitter

Swissmeda AG Technoparkstrasse 1 8005 Zürich Switzerland E-Mail: info@swissmeda.com, joerg.danzberg@swissmeda.com

5.2 Official Correspondent

Dr. Jörg Danzberg, Chief Executive Officer Swissmeda AG Technoparkstrase 1 8005 Zürich Switzerland Phone: +41 43 818 2515 Fax: +41 43 818 2517 E-Mail: joerg.danzberg@swissmeda.com

5.3 Date of Submission

07/01/2011

5.4 Device Information

Trade name:	Swissmeda Dental Planning System
Version:	2.4
Common Name:	Dental Planning System
Device Class:	Class II
Classification Name:	System, Image Processing System, Radiology
Regulation Description:	Picture archiving and communications system
Classification Number:	21 CFR 892.2050
Product Code:	LLZ

5.5 Predicate Device

Manufacturer: Germany Trade Name: 510(k) Number: Regulation Number: Product Code:

IVS Solutions AG, Annaberger Strasse 240, Chemnitz,

coDiagnostiX® K071636 892.2050 LLZ

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5.6 Device Description

Swissmeda Dental Planning System is a stand-alone software device.

For each patient several versions of the plan can be created, restored and exported each time.

The drilling device from company Georg Schick Dental GmbH is a high accuracy positioning table, which also can be used like conventional rotary tables for purposes of model making.

5.7 Intended Use

Swissmeda Dental Planning System is intended for use by qualified dental professionals for Windows® based diagnostics and implant planning.

The software is an interface for imaging data that originates from medical scanners such as CT or DVT scanners and it is also a pre-operative software for simulation and

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evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options.

Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

The planning data may be exported from Swissmeda Dental Planning System and used as input data for the mentioned drilling device for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning.

5.8 Safety Information

Swissmeda Dental Planning System is a stand-alone software device 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 identified and analyzed. The result of this analysis indicates that the device is of moderate level of concern as per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

5.9 Substantial Equivalence

The Swissmeda Dental Planning System is substantially equivalent to and performs as good as the predicate device coDiagnostiX® (K071636) based on the equivalence of the intended use, similar features and technological characteristics. Any differences between the devices do not raise new issues of safety and effectiveness.

5.10 Conclusion

Swissmeda Dental Planning System considered to be substantially equivalent to the coDiagnostiX® System.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. 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 emblem featuring three abstract shapes that resemble human figures or birds in flight. The emblem is rendered in black, providing a stark contrast against the white background.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JAN 2 5 2012

Dr. Jorg Danzberg Chief Executive Officer Swissmeda AG Technoparkstrase 1 8005 ZURICH SWITZERLAND

Re: K112251

Trade/Device Name: Swissmeda Dental Planning System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 6, 2011 Received: December 19, 2011

Dear Dr. Danzberg:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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

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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _(1112251

Swissmeda Dental Planning System Device Name:

Indications for Use:

Swissmeda Dental Planning System is intended for use by qualified dental professionals for Windows® based diagnostics and implant planning.

Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.

AND/OR Over-The-Counter Use Prescription Use _ × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

Division Sign-Øff Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112251

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).