IPS is prescription use software used by dentists and dental lab technicians for the visualization and image segmentation of DICOM data from medical scanners such as CT. The software aids the user in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants.

Device Description

IPS is a Dental 3D Planning Software that aids dentists and dental lab technicians in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants. The data used for planning the treatment course is obtained from radiological devices (e.g., CT) complying with DICOM format. IPS provides dentists with various visualization and measurement tools which facilitate in generating dental panoramic view, segmenting of the dental anatomical structures and measuring bone density and distance between the dental implants.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dental 3D Planning Software IPS:

Summary of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Type
DICOM Conformance: - Importing DICOM Data. - Sorting DICOM data. - Grouping multiple DICOM cases.	Results of all testing demonstrate that IPS does not raise any new issues of safety, effectiveness or performance when compared to the existing predicate devices. The software conforms to DICOM standard and it has been verified and validated for it.	Validation and verification study (DICOM Conformance Testing)
Safety, Effectiveness, and Performance (implicitly, based on substantial equivalence to predicates)	No new issues of safety, effectiveness, or performance compared to predicate devices.	Comparison to predicate devices, supported by DICOM conformance testing.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of DICOM cases or patient data used for the "Validation and verification was performed to demonstrate DICOM conformance." It mentions "These test cases are performed on the patient's DICOM images," but the quantity is not specified.
- Data Provenance: Not specified. It's unclear if the data was retrospective, prospective, or its country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study described is a technical validation of DICOM conformance, not a clinical study involving expert assessment of diagnostic accuracy or treatment planning outcomes. Ground truth in this context would likely be the expectation of proper DICOM data handling, rather than clinical interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As this was a technical validation of DICOM conformance, an adjudication method for clinical agreement is not relevant.
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 comparative effectiveness study was performed or described. This submission focuses on establishing substantial equivalence based on intended use, technology, and DICOM conformance, not on the comparative clinical performance of human readers with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "Validation and verification was performed to demonstrate DICOM conformance" is implicitly a standalone performance test of the software's ability to handle DICOM data. The software is described as a "pure software device" for "visualization and planning simulation," indicating its primary function is independent image processing and display. However, it's not a standalone diagnostic algorithm in the sense of making a diagnosis without human input; it's a tool for human planning.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the DICOM conformance testing would be the DICOM standard itself. The test cases were designed to verify that the software correctly imports, sorts, and groups DICOM data according to the established rules and specifications of the DICOM standard.
The sample size for the training set:
- Not applicable. This device is a dental 3D planning software and the provided text does not describe an AI/machine learning model that would require a "training set." The validation described is for DICOM conformance, which is a functional test, not a learning algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device.

Summary

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510k Summary

DEC - 6 2011

Device Owner Address:

Telephone: Fax:

Official Correspondent

Telephone: Email:

Symbvo Dental, LLC, 15310 Amberly Drive suite#250 Tampa FL 33647 (877) 479-6296 (866) 697-8559

Amberry Drive suite#250
FL 33647
479-6296
697-8559

Parul Chansoria 87 Hulme Ct Apt. 216 Stanford CA 94305 877-479-6296 parul@symbyo.com

Device Name and Classification

Trade Name/Product Name:	IPS	Areas ofComparison	Simplant systemK033849	Sicat implantK090119	IPS
Common/Usual Name:	Dental 3D Planning Software	Description	Pure software device	Pure software device	Pure software device
Classification Name:	System, Image Processing, Radiological; 21CFR892.2050	Input source	CT scanners, MRImachines	CT scanners, DVTscanners	Cone beam CTmachines, CTscanners
Product Code:	LLZ	Data conformance	DICOM	DICOM	DICOM
Regulation Number:	Picture Archiving and Communication System, 21CFR892.2050	Regulationdescription	Picture archiving andcommunication system	Picture archiving andcommunication system	Picture archiving andcommunication system
Panel:	Radiology	Intended use	Visualization andplanning simulation thataids the user in theplacement of dentalimplants and planningfor surgical treatments	Visualization and planningsimulation that aids theuser in the placement ofdental implants andplanning for surgicaltreatments	Visualization andplanning simulationthat aids the user in theplacement of dentalimplants and planningfor surgical treatments
Class	2	Intended user	Well trained dentist <br>dental technicians	Well trained dentist	Dentists, dentaltechnician
Substantial Equivalence claimed to:	MATERIALISE N.V. Simplant system (K033849)	Main tools	Visualization, implantplacement,measurement ofdistance, anglemeasurement, densitydetermination,segmentation tool	Visualization, implantplacement, measurementof distance, anglemeasurement, densitydetermination	Visualization, implantand nerve placement,measurement ofdistance, anglemeasurement, densitydetermination,segmentation tool
	siCAT GmbH & Co. KG Sicat implant (K090119)	Host platform	PC	PC	PC
Operating system	Not specified	Not specified	Windows XP, vista, 7
Outputcompatibility	CAD, rapid prototypingmachines	CAD, rapid prototypingmachines	CAD, rapidprototyping machines
Operating systemcompatibility	- Windows XP or vista- Intel based MAC(computer should bebooted from windowsnot MAC OS)	- Windows XP- Windows Vista- WINDOWS 7	- Windows XP- Windows Vista- WINDOWS 7

Device Description

Indications for Use

Substantial Equivalence

Symbyo Dental LLC. wishes to use the following devices as a predicates: MATERIALISE N.V. Simplant system (K033849) siCAT GmbH & Co. KG Sicat implant (K090119)

The claim of substantial equivalence to the predicate devices is based on both intended use and technology used.

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Predicate Comparison Table

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Based Upon Intended Used:

IPS and its predicate devices have intended use; which is Visualization and planning simulation that aids the user in the placement of dental implants and planning for dental surgical treatment.

Based Upon Technology Used:

IPS, like the predicate devices, is a pure software device with DICOM data conformance.

The technological characteristics of IPS vs. the predicate devices are summarized below.

Our software conforms to DICOM standard and it has been verified and validated for it.

Validation and verification was performed to demonstrate DICOM conformance

Following test cases were used to validate DICOM conformance:

Importing DICOM Data.
Sorting DICOM data.
Grouping multiple DICOM case

These test cases have been adopted to perform a validation process according to the IPS DICOM Conformance statement. These test cases are performed on the patient's DICOM images to ensure that the IPS application's modules are fully compliant with the DICOM conformance.

Conclusion

The results of all testing demonstrate that IPS does not raise any new issues of safety, effectiveness or performance when compared to the existing predicate devices.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

Symbyo Dental, LLC. % Mr. Mark Job -- Official Correspondent 1394 25th Street NW Buffalo MN 94305

Re: K113404 Trade/Device Name: Dental 3D Planning Software IPS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2011 Received: November 18, 2011

Dear Mr. Job:

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

DEC - 6 2011

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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/ReportalProblem/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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Device Name: Dental 3D Planning Software IPS

Indications for Use:

Prescription Use × (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 Diagnostic Devices (OIVD)

.l.O.D.R.

ostic Device

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).