CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.

Device Description

CephSimulation is an interactive imaging software device. It is used for the visualization of patient image files from scanning devices such as CT scanners, and for assisting in case diagnosis and review, treatment planning and simulation for orthodontic and craniofacial applications. Doctors, dental clinicians, medical surgeons and other qualified individuals can render, review and process the images, perform measurement, analysis and surgery simulation. The software runs with standard PC hardware and visualizes imaging data on standard computer screen. CephSimulation is designed as a plug-in component for InVivoDental software. It is seamlessly integrated into InVivoDental for extended capabilities. The key functionality includes image visualization, cephalometric tracing and measurements and 3D surgery simulation.

AI/ML Overview

The CephSimulation device is a software application intended for storing and visualizing patient images, assisting in case diagnosis, and surgical treatment planning.

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

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a general approach to performance validation. However, based on the narrative, the implicit acceptance criterion is that the software is "as effective as its predicate in its ability to perform essential functions."

Acceptance Criteria (Implied)	Reported Device Performance
Software is stable and operates as designed.	Confirmed by performance testing, usability testing, and final acceptance testing.
Software has been evaluated for hazards and risk is reduced to acceptable levels.	Confirmed by risk analysis and traceability analysis.
CephSimulation is as effective as its predicate in its ability to perform essential functions.	Confirmed by bench testing against predicate software, evaluated by an expert radiologist.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify the exact sample size (number of cases or images) used for bench testing. It only mentions "evaluation of major function outputs from CephSimulation and predicate software."
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: "an expert" (singular) was used.
Qualifications of Experts: The expert was "in the field of radiology." No further details on years of experience or sub-specialization are provided.

4. Adjudication method for the test set:

The document does not describe a formal adjudication method (like 2+1 or 3+1). It states that the bench testing result "was evaluated by an expert in the field of radiology," implying a single-expert assessment rather than a consensus-based adjudication.

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, evaluating human reader improvement with vs. without AI assistance, was not conducted or reported in the provided document. The testing focused on the standalone performance of the CephSimulation software compared to a predicate.

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

Yes, a standalone performance assessment was done. The "bench testing of the software with predicate software" compared the outputs of CephSimulation directly against those of the predicate software, essentially evaluating the algorithm's performance without the user interface being the primary focus of comparison. The expert reviewer evaluated "major function outputs from CephSimulation and predicate software."

7. The type of ground truth used:

The ground truth for the bench testing was the "major function outputs" of the predicate software. This implies that the predicate's performance or outputs were considered the reference truth for comparison, rather than an independent expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

The document does not provide any information regarding the sample size used for the training set, as it describes validation testing (benchmarking) rather than development or training details.

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

Since no information on a training set is provided, there is no mention of how its ground truth was established.

Summary

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

January 4, 2017

Anatomage, Inc. % Mr. Changxin Xu Program Director 303 Almaden Blvd., #700 SAN JOSE CA 95110

Re: K161270 Trade/Device Name: CephSimulation

Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 23, 2016 Received: November 29, 2016

Dear Mr. Xu:

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 either 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.

Michael D'Hara

For

Robert Ochs, Ph.D. 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) K161270

Device Name CephSimulation

CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC.

This device is not indicated for mammography use.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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510K Summary

I. Submitter

Anatomage Inc. 303 Almaden Blvd #700 San Jose, CA 95110 Phone: (408) 885-1474 Fax: (408) 295-9786 Contact Person: Changxin Xu, Program Director Preparation Date: 4/29/2016

II. Device

Device Name	CephSimulation
Common Name	Radiological Image processing System
Classification	Class II
Classification Name	Radiological Imaging Processing System, 21 CFR 892.2050
Product Code	LLZ

III. Predicate Device

Primary Predicate Device: K110430, Dolphin Imaging Reference Device: K123519, InVivoDental

IV. Device Description

CephSimulation is designed as a plug-in component for InVivoDental software. It is seamlessly integrated into InVivoDental for extended capabilities. The key functionality includes image visualization, cephalometric tracing and measurements and 3D surgery simulation.

V. Indication for Use

The indication for Use statement for CephSimulation is not identical to the primary predicate

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device. However, the difference is CephSimulation is not indicated for mammography use. This restriction does not affect the safety and effectiveness of the device relative to the predicate.

VI. Technical Characteristics and comparison with the predicate device

CephSimulation is a software only device that handles digital medical images. This device does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by this software but by doctors, surgeons and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

CephSimulation is installed on standard off-the-shelf x86 processor based computers.

Comparison of the proposed devices with the primary predicate device and reference device is summarized in the following table:

Characteristic	Proposed Device (CephSimulation)	Primary Predicate Device (Dolphin Imaging)	Reference Device (InVivoDental)
501(k) number	Pending	K110430	K123519
Indication for use	CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.	Dolphin Imaging software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.	InVivoDental is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRJ, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, InVivoDental is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. This device is not indicated for mammography use.
Operation system	Windows	Windows or Mac OS	Windows
User interface	Mouse, Keyboard	Mouse, Keyboard	Mouse, Keyboard
TechnologyPlatform	PC based	PC and MAC	PC based
Standalonesoftware	Plug-in view ofInVivoDental (K123519)	Yes	Yes
Imagerendering	2D and 3D	2D and 3D	2D and 3D
Imagemanipulation	Preview, Rotate,Enhance, Zoom,Brightness, Contrast	Preview, Rotate, Enhance,Zoom, Brightness,Contrast, Sharpness	Preview, Rotate, Enhance,Zoom, Brightness, Contrast,Sharpness
Basic Imagemeasurement	Distance, angle	Distance, angle	Distance, angle
Cephalometricmeasurement	Distance, angle, ratio,difference	Distance, angle, ratio,difference	None
Cephalometrictracing	Manual point pickingand structure drawing,Software providespredefined landmarks,structures and allowsuser to define their own.Can trace on 3D volume.	Manual point picking andautomatic structuretemplatesSoftware providespredefined landmarks andtracing structures.Can trace on 3D volumeand 2D photo.	None
Cephalometricanalysis	Provides both 3D and2D analysis. Allmeasurements arecreated in 3D. 2Danalysis is created byprojecting 3Dmeasurements ontoplane (mid-sagittalplane).Standard orthodontictracing analyses anduser-configurableanalysis:Lateral Analyses:- ABO- Alabama- Steiner- Alexander- Downs	Provide both 3D and 2Danalysis. 3D analysis isperformed on 3D volume.2D analysis is performedon 2D photo or x-ray.Standard orthodontictracing analyses and user-configurable analysis:Lateral Analyses:- Ricketts- McNamara- Steiner (Tweed)- Jarabak- Roth- Sassouni- McLaughlin- Downs-Northwestern- Bjork- Alexander (Vari-	None

	- Iowa- McLaughlin	Simplex)- Holdaway
	- McNamara	- Alabama
	- Summary	- Burstone
	- Tweed	- ... more than 400 in all
	- Univ. of Pacific
	- Ricketts	Frontal Analyses:
	- Bjork	- Ricketts
	- Sassouni BottomLine	- Van Arsdale
		- Grummons
	Frontal Analyses:	- Grummons Simplified
	- Grummons SimplifiedFrontal
	- Grummons SimplifiedMidline	Arch Analysis (ModelsStudy)
	- Grummons PlusFrontal	- Bolton- Schwarz
	- Grummons PlusHeight, Angle, Ratio

	3D Analyses:
	- Cranial Skeletal
	- Cranial Dental

Tracingsuperimposition	Yes	Yes	No
Wigglegram	Yes. Allow user to enternorms and standarddeviations.	Yes. Allow user to enternorms and standarddeviations.	No
Profilogram	Yes	No	No
Occlusal gram	Yes	No	No
2D growthsimulation	No	Yes. Growth forecast ontraced x-ray or tracingoverlaid on photo	No
Treatmentplanning andsimulation	Orthodontic andcraniofacial applicationsusing predefinedmaxillary, mandible,chin, and cheek cuts.User can translate, rotatethe cuts.	Orthodontic andorthognatic applicationsusing maxillary, mandible,and chin cuts.User can translate, rotatethe cuts.	No surgery cut functions.
Soft tissuedeformation	Yes. 3D only.	Yes. 2D and 3D	No
	photos on volume image	photos on volume image
Implant module	Not in this device	Yes (IMPLANNER)	Yes
Scannerconnection	No	Yes	No
DICOMsupport	Yes (through hostdevice: InVivoDentalK123519)	Yes	Yes

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VII. Performance Data

The following quality assurance measures were applied to the development of the system:

· Risk Analysis
· Traceability Analysis
· Design Reviews
· Performance testing
· Usability testing
· Final acceptance testing
· Bench testing to compare with predicate software

Testing confirmed that the software is stable and operating as designed. Testing also confirmed that the software has been evaluated for hazards and that risk has been reduced to acceptable levels.

Bench testing of the software with predicate software was performed by evaluation of major function outputs from CephSimulation and predicate software. The testing result was evaluated by an expert in the field of radiology. This testing confirms that CephSimulation is as effective as its predicate in its ability to perform essential functions.

VIII. Conclusions

Based on the intended use, product, performance, and testing information provided in this notification, the subject device has been shown to be substantially equivalent in the area of technical characteristics, general functionality, and indicated use to the currently marketed predicate device and does not introduce any new potential risks.

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).