GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.

Device Description

GALILEOS Implant is a pure software device. GALILEOS Implant is an Add-On to the 3D-viewing software Sirona GALAXIS. GALILEOS Implant adds features for pre-operative simulation / evaluation of dental implant placement and surgical treatment options. GALILEOS Implant allows to name, position, move, rotate, resize and visualize generic dental implants and other planning objects (i.e. nerve canals) within the 3D volume data visualized by Sirona GALAXIS. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.

AI/ML Overview

The GALILEOS Implant 510(k) summary does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks a dedicated section outlining acceptance criteria, a detailed study design, sample sizes for training or test sets, expert qualifications, or adjudication methods.

This document describes the device as substantially equivalent to a predicate device (SimPlant System K033849) based on intended use, features, and technical characteristics. It mentions "Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions," but provides no details of these tests, their results, or the criteria used to judge them.

Here's a breakdown of what information is not available in the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The submission claims substantial equivalence to the predicate device, implying that its performance is comparable and acceptable for its intended use.	"Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions." (No specific metrics or results are provided, nor are the 'acceptance criteria' for these tests.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. It can be inferred that the software processes 3D volume data from the Sirona GALILEOS medical cone beam scanner, but the origin of data used for testing (e.g., country, retrospective/prospective) is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The device is intended for "qualified dental professionals," but whether these professionals were involved in establishing ground truth for testing is not detailed, nor are their credentials.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? Not mentioned. The document focuses on demonstrating substantial equivalence of the software rather than a comparative effectiveness study involving human readers with and without AI assistance.
Effect Size: Not applicable, as no MRMC study is reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Yes, implicitly. The "validation testing and bench tests of the software functions" would fall under standalone performance assessment. However, no specific metrics or results from such a study are provided. The device itself is described as "pure software," thus any "performance testing" would inherently be standalone.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified. Given the nature of dental implant planning software, it's possible that ground truth could involve:
- Expert consensus on optimal implant placement.
- Comparison to physically planned models or surgical outcomes (though outcomes data is less likely for initial software validation).
- Pathology (e.g., histological verification) is highly unlikely for this type of software.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. (It's possible, given the time frame of the submission (2006) and the nature of "pure software" for planning, that traditional machine learning 'training' data in the modern sense might not have been a primary component of its development or validation. It might have been rule-based or algorithmic.)

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established (Training Set): Not specified. (As above, if traditional machine learning was not the primary methodology, then a 'training set' ground truth might not be applicable in the same way.)

Summary of what is known/inferred:

Device Name: GALILEOS Implant
Intended Use: Planning and simulation software to aid qualified dental professionals in placing dental implants and planning surgical treatments, based on medical imaging from Sirona GALILEOS 3D viewer.
Regulatory Clearance: 510(k) (K061472) based on substantial equivalence to SimPlant System (K033849).
Performance Claim: "Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions."
Nature of Software: Pure software device, an add-on to Sirona GALAXIS 3D-viewing software.

The provided 510(k) summary is typical for this type of submission from that era, focusing on substantial equivalence rather than detailed performance study reports with specific metrics, acceptance criteria, and ground truth methodologies that are common in more recent AI/ML device submissions.

Summary

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Kob 1472

510(k) Summary

for

GALILEOS Implant

1 Company Name and Address

(JUN - 9 2006

1.1 Sponsor

siCAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany

Manufacturer

siCAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany

1.2 Contact

siCAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany

Telephone: +49-228/854 697 84 Facsimile: +49-228/854 697 99

Primary Contact: Mr. Markus Pfister Secondary Contact: Mr. Dr. Manfred Breuer

2 Device Name

Proprietary Name: GALILEOS Implant Common/Usual Name: Preoperative Dental Implant Planning Software Classification Name: System, Image Processing, Radiological Regulation Description: Picture archiving and communications system

3 Predicate Device

The GALILEOS Implant is claimed to be substantially equivalent in material, design and function to the SimPlant System product which was cleared by FDA under 510(k) K033849 on May 25, 2004.

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য Device Classification

Picture archiving and communications systems (21 CFR 892.2050, Product Code LLZ) have been classified as Class II devices and are reviewed by the Radiology Panel.

5 Device Description

GALILEOS Implant is a pure software device.

GALILEOS Implant is an Add-On to the 3D-viewing software Sirona GALAXIS. GALILEOS Implant adds features for pre-operative simulation / evaluation of dental implant placement and surgical treatment options. GALILEOS Implant allows to name, position, move, rotate, resize and visualize generic dental implants and other planning objects (i.e. nerve canals) within the 3D volume data visualized by Sirona GALAXIS. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.

ર Intended Use

GALILEOS Implant is intended for use as planning and simulation software to aid gualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.

7 Substantial Equivalence

The GALILEOS Implant system is substantially equivalent to the SimPlant System (K033849) based on the equivalence of the intended use, similar features and technical characteristics. Performance testing to validate the safety and effectiveness of the GALILEOS Implant system included validation testing and bench tests of the software functions.

8 Conclusion

GALILEOS Implant is considered to be substantially equivalent in design, material and function to the SimPlant System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 9 2006

siCAT GmbH & Co. KG % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K061472

Trade/Device Name: GALILEOS Implant Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 26, 2006 Received: May 30, 2006

Dear Mr. Preiss:

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/2/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial of the FDA from 1906-2006. The letters FDA are in bold in the center of the logo. The word Centennial is written below the letters FDA.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act thany Federal statutes and regulations administered by other Federal agencies. You must or uny 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) I ms letter witification. The FDA finding of substantial equivalence of your device to a legally premated 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)(Radiology)	240-276-0115
21 CFR 894.xxx		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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Chrogdon

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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INDICATIONS FOR USE STATEMENT 2

for GALILEOS Implant

510(k) Number (if known): Ko 6 1 4 7 2

ﮯ

Device Name: GALILEOS Implant

Indications for Use:

GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALLEOS Implant and used as input data for CAD or Rapid Prototyping Systems.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram

(Division Sign-Off) Division of Reproductive Andomina and Radiological Devices 510(k) Number

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).