Maven Pro is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants and surgical treatment.

Device Description

Maven Pro Graphic Station is a fully-featured 3D imaging application in medicine. Its unique open architecture and modular framework make customization and integration options trivial. On demand, nSequence will create a fully customized 3D medical imaging solution.

Maven Pro Graphic Station supports all the common 3D medical imaging functionalities used by professional doctors to support their diagnosis. It includes various Volume and IsoSurface rendering, segmentation tools, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. Since 2D imaging is still an important feature, it is possible to switch with a single click to a 2D view, use an even more sophisticated MPR view or switch back to the 3D view.

Maven Pro software is characterized by its intuitive user interface, 2D, MPR and 3D imaging, prime image quality and extensive visualization options, fast image rendering, measurement and analysis tools, and easy integrated reporting.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria. The 510(k) summary focuses on establishing substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than presenting a performance study with acceptance criteria.

The document states:

"A comparison of the predicate device and Maven Pro shows that many of technological characteristics of the two devices are similar. The differences between the two devices do not raise new questions of safety and effectiveness."
"Maven Pro is substantially equivalent to a legally marketed device. Although it has some technological characteristics that differ from that of predicate, it has the same intended use as the predicate and raises no new questions of safety and effectiveness."

This indicates that the regulatory clearance was based on a comparison to a predicate device, rather than a separate performance study with defined acceptance criteria for the Maven Pro itself.

Therefore, I cannot extract the following information because it is not present in the provided text:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The document primarily describes the device's features, intended use, and its claim of substantial equivalence to a predicate device (Invivodental, K070803). It does not outline a specific performance study dataset, expert reviews, ground truth establishment, or statistical metrics against acceptance criteria.

Summary

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K130242
Page 1 of 2

510(k) Summary

Date of Submission: October 9, 2012

Submitter: nSequence 5420 Kietzke Lane, Suite 205 Reno, NV 89511

Contact Person:	Daniel Llop, President/CEO
Phone :	775-827-6645
Fax :	775-827-6650

Subject Device:

Proprietary Name:	Maven Pro
Classification Name:	System, Image Processing, Radiological
Regulation:	892.2050
Product Code:	LLZ

Predicate Devices:

Name of device	Invivodental
Manufacturer:	Anatomage, Inc.
K number:	K070803
Product Code:	LLZ

AUG 2 9 2013

Device Description:

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K130242
Page 2 of 2

Intended Uses:

Risk Analysis Method:

The risk analysis for the device was conducted according to EN ISO 14971:2009.

Summary of Technological Characteristics:

A comparison of the predicate device and Maven Pro shows that many of technological characteristics of the two devices are similar. The differences between the two devices do not raise new questions of safety and effectiveness.

Conclusion:

Maven Pro is substantially equivalent to a legally marketed device. Although it has some technological characteristics that differ from that of predicate, it has the same intended use as the predicate and raises no new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

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

August 29, 2013

nSequence % Rhonda Alexander, MS, MPA Senior Regulatory Specialist Registrar Corp 144 Research Drive HAMPTON VA 23666

Re: K130242

Trade/Device Name: Maven Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 16, 2013 Received: July 17, 2013

Dear Ms. Alexander:

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 for use stated in the enactment date of 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 I va may, morelor, manel of the Act include requirements for annual registration, listing of general connels proficioning 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 or any I ouvar statution and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Rhonda Alexander, MS, MPA

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.

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

http://www.fda.gov/MedicalDevices/Resources.forYou/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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smhi

for

Janine M. Morris 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

K130242 510(k) Number (if known):

Maven Pro Device Name:

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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).