Improvis Imaging is a Windows-based software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intra-oral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Features include resizing, rotating, embossing and sharpening of images.

Improvis Imaging is written using three programming languages (C++, C#, TSQL) and is designed to work with standard personal computers capable of running Windows 2000 or higher.

Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.

Device Description

Improvis Imaging is a software package that allows dental clinicians to acquire images from standard dental imaging devices and commercially available scanners, digital cameras and intraoral cameras. It is designed to be used as an imaging database for storage and organization of patient digital images and radiographs. Once acquired, images can be enhanced for viewing by applying image processing functions which include resizing, rotating, embossing and sharpening of images. All images are compressed using lossless compression and stored in a shared relational database.

The Improvis software interacts with the medical device software drivers, not the medical devices themselves. This interaction allows the computer system to acquire images captured via webcams, intraoral video cameras, panoramic x-rays, and other solid state sensors. These images are digitized by the outside vendor supplied medical devices, and then communicated via Improvis to the patient record. Once the images have been received by the system, they are embedded within the patient's dental record and can be accessed from any associated practice location.

Radiographic images are compressed via a lossless system and can be manipulated and enhanced to suit the dental care provider's needs. Non-diagnostic images, such as scanned documents, may be compressed using non-lossless methods which optimize image quality and storage requirements. Original compressed images are stored prior to application of any image processing algorithms.

Image processing by Improvis Imaging utilizes industry standard algorithms that do not result in the alteration of an image's or radiograph's content and will not introduce false data or modification into the acquired image. Improvis Imaging does not control the x-ray taking system and does not generate x-ray images directly from the physical device, but does provide the tools that permit the user to enhance images for diagnostic purposes.

Improvis Imaging is a three tier application consisting of user interface, business objects (which provide communication between the user interface and database tiers), and database. The top two tiers of the program are written in Microsoft Visual Studio .NET C#, while the database components are written in Microsoft T-SQL. Improvis Imaging is a Microsoft Windows Forms (non-browser based) 32 bit application designed to run on Windows-compatible personal computers running the Microsoft Windows XP (or higher) operating system. Imaging processing functions are provided through the integration of a third party software development toolkit from Lead Technologies, Inc.

Improvis Imaging is designed for use in a client-server environment in which the user interface portion of the application runs on an individual user's computer workstation as a Windows executable application. The Improvis Imaging shared database is installed on a single or clustered server running Microsoft SQL Server. The workstations and server are connected by a network using Microsoft Windows IP protocols. The application is designed for use in a Microsoft Windows Active Directory domain for authentication and access control, but can also run in non-Active Directory workgroups using internal Improvis access control.

Improvis Imaging is not compliant with DICOM standards.

AI/ML Overview

The request asks for specific details regarding acceptance criteria and a study proving a device meets these criteria. However, the provided document is a 510(k) Summary for the IMPROVIS® Imaging System, which is a dental imaging software. This document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria for a new algorithmic function.

Therefore, many of the requested details, such as specific acceptance criteria for algorithmic performance, effect size of AI assistance on human readers, details of ground truth establishment for a test set, and sample sizes for training/test sets in the context of an algorithm's performance evaluation, are not available in the provided text. The document describes the software's functionality and its comparison to existing devices.

Here's an analysis of the information that can be extracted or inferred from the provided text, along with a clear indication of what is missing:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in the context of quantitative performance metrics for a specific algorithmic function. Instead, its primary "acceptance criteria" for the 510(k) submission is substantial equivalence to predicate devices in terms of intended use and technological characteristics. The reported "performance" relates to the similarity of features rather than measurements against a threshold.

Comparison Areas	IMPROVIS Imaging Performance (Reported)	Acceptance Criteria (Inferred from Substantial Equivalence Goal)
Intended Use (Acquisition, viewing, editing, storage of dental radiographs and patient image records)	Same as predicate devices	Must be "Same" as predicate devices
Intended Users (Trained dental professionals)	Same as predicate devices	Must be "Same" as predicate devices
Operating System Support	Microsoft Windows XP or higher (32 & 64 bit)	Must be comparable or superior to predicate devices (Win 2000+ for Visix, Win 98+ for TigerView)
Network Compatibility	Ethernet IP 100 mbps or greater	Must be "Same" as predicate devices
Monitor Resolution	800 x 600 or greater	Must be comparable or superior to predicate devices (1024x768 for Visix, 800x600 for TigerView)
User Interaction	Keyboard/Mouse	Must be "Same" as predicate devices
CPU	2 GHz Pentium or higher	Must be "Same" as predicate devices
RAM	1 GB or higher	Must be "Same" as predicate devices
Multi-User Capability	Yes	Must be "Same" as predicate devices
Image Import/Export	Yes (BMP, TIFF, JPG)	Must be comparable or superior to predicate devices (TIFF, JPG for predicates)
Acquisition Devices	Sensor, Camera, Scanner, File Import	Must be "Same" as predicate devices
Imaging Interfaces	Microsoft DirectX Version 9.0+, TWAIN 2.0+	Must be comparable or superior to predicate devices (Proprietary, DirectX, TWAIN for predicates)
Image Organization	Create Series, Move Images, Create Series Template	Must be comparable to predicate devices (Mount Images, Move within Mount, Create a Mount)
Image Search Available	Yes	Must be "Same" as predicate devices
Image Storage (Original data unaltered)	Yes	Must be "Same" as predicate devices
Image Storage (Lossless compression of radiographic images)	Yes	Must be comparable (Predicates show Lossless/lossy compression)
Image Storage (Full history of enhancements recorded)	Yes	Must be comparable to predicate devices (History of operations)
Database Storage	Microsoft SQL Server database	Must be robust and comparable to predicate devices (Filesystem for predicates)
Database Software	SQL Server 2005 or higher	Must be robust and comparable to predicate devices (Filesystem for predicates)
Image Viewing Features	Zoom, Full Screen, Scale, Rotate, Flip, etc.	Must be "Same" as predicate devices
Image Measurement Features	Line, Angle, Calibrate, Line Color/Show/Hide	Must be "Same" as predicate devices
Image Annotation Features	Line, Free Line, Circle, Rectangle, Arrows, Text, Color, Width, Show/Hide	Must be comparable to predicate devices (Lines, Freehand, Circle, Square, Arrows, Text, Color, Width, Show/Hide)
Image Operations (Enhancement & Manipulation)	Magnifier, Print, Negative, Colorize, Emboss, Sharpen, Original Image, Brightness, Contrast, Gamma	Must be comparable or superior to predicate devices (Magnifying Glass, Print, Negate, Colorize, Pseudo 3D, Sharpen Edge, Original Image, Brightness, Contrast, Gray Shift (Gamma))
Security	Login, admin, and feature access	Must be comparable or superior to predicate devices (Login and admin)

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

Not applicable / Not provided. The document is for a general-purpose dental image management and enhancement software. It does not describe a clinical study focused on the diagnostic performance of an algorithm that would require a test set of medical images. The software provides tools for image manipulation (e.g., sharpening), but these are standard and not presented as novel AI algorithms requiring validation with a specific test set.

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 test set performance study is described.

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

Not applicable / Not provided. No test set performance study 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. The document does not describe an MRMC study. The software provides image enhancement tools, but not "AI assistance" in the sense of a diagnostic algorithm being evaluated for its impact on reader performance.

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

No. This device is a software package for managing, viewing, and enhancing images by human users. It is not a standalone algorithm providing diagnostic outputs. The image processing functions use "industry standard algorithms that do not result in the alteration of an image's or radiograph's content and will not introduce false data or modification into the acquired image."

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

Not applicable / Not provided. No specific ground truth for an algorithmic diagnostic function is relevant or discussed in the document. The "ground truth" for the software's functionality is its ability to perform the stated image management and manipulation tasks as intended and as demonstrated by its feature list, which is compared to predicate devices.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/ML diagnostic algorithm that requires a training set.

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

Not applicable / Not provided. This is not an AI/ML diagnostic algorithm that requires a training set.

Summary

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American Dental Partners, Inc. 401 Edgewater place Suite 430 Wakefield, MA 01880

MQW 1: 0 2010

510(k) Summary

IMPROVIS® Imaging System

The following information is presented as required by 21 C.F.R. § 807.92:

Date Prepared:	September 29, 2010
Submitter:	American Dental Partners, Inc.401 Edgewater Pl., Ste. 430Wakefield, MA 01880-6225
EstablishmentRegistration Number:	To be obtained
Manufacturing Site:	American Dental Partners, Inc.3000 Bethesda Place, Suite 501Winston-Salem, NC 27103Phone: 336-765-3900
Contact Person:	Timothy RodenbergerGeneral CounselAmerican Dental Partners, Inc.Tel: 781-213-0255Fax: 781-224-4216Email: TRodenberger@amdpi.com
Device Trade Name:	IMPROVIS® Imaging System
Common Name:	Dental Imaging Software
Device Classification:	Picture Archiving and Communications System
Product Code:	LLZ
Regulation:	21 C.F.R. § 892.2050
Device Classification:	Class II

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Predicate Devices:

Televere Systems	Visix Imaging	K082623
Televere Systems	TigerView Professional	K061035

Device Description

Improvis Imaging is designed for use in a client-server environment in which the user interface portion of the application runs on an individual user's computer workstation as a Windows

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executable application. The Improvis Imaging shared database is installed on a single or clustered server running Microsoft SQL Server. The workstations and server are connected by a network using Microsoft Windows IP protocols. The application is designed for use in a Microsoft Windows Active Directory domain for authentication and access control, but can also run in non-Active Directory workgroups using internal Improvis access control.

Improvis Imaging is not compliant with DICOM standards.

Intended Use

Narrative Description of Substantial Equivalence:

The Improvis Imaging system is substantially equivalent to the predicate devices identified above. In particular, Improvis Imaging has the same intended use and similar technological features as the predicate devices. Like Visix Imaging and TigerView Professional, Improvis Imaging is a software application that supports the acquisition, viewing and editing of images and data from an imaging source. Images can be acquired from document scanners, intraoral video cameras, web cameras, digital cameras, and radiographic systems. Images are associated with patient records and presented using standard computer workstations and displays. The software is intended for use by dental professionals for diagnostic purposes, case documentation, and patient education. Users can overlay annotations on images, as well as calibrate and measure images. Methods such as brightness and contrast adjustment, sharpening, colorization, and reorientation are provided to allow images to be enhanced for optimal viewing. Images can also be printed and exported.

A comparison of the characteristics of the current device and the predicate devices is set forth in the charts below.

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Device Comparison

Table 1. Device Comparison

Comparison Areas	IMPROVIS Imaging	Visix Imaging	TigerView Professional
Intended Use	Acquiring, viewing, editing andstorage of dental radiographsand related patient imagerecords	Same	Same
Intended Users	Trained dental professional	Same	Same
DICOM Compatible	No	Optional	Optional
Operating System	Microsoft Windows XP or higher32 and 64 bit OS	Microsoft Windows2000 or higher32 bit OS	Microsoft Windows 98or higher32 bit OS
Network	Ethernet IP 100 mbps or greater	Same	Same
Monitor	800 x 600 or greater	1024 x 768 or greater	800 x 600 or greater
User Interaction/Input	Keyboard/Mouse	Same	Same
CPU	2 GHz Pentium or higher	Same	Same
RAM	1 GB or higher	Same	Same
Multi-User	Yes	Same	Same
Import/Export Images	Yes (BMP, TIFF, JPG)	Yes (TIFF, JPG)	Yes (TIFF, JPG)
Acquisition Devices	SensorCameraScannerFile Import	Same	Same
Imaging Interfaces	Microsoft DirectX Version 9.0and higherTWAIN 2.0 and higher	ProprietaryDirectXTWAIN	ProprietaryDirectXTWAIN
Image Organization	Create SeriesMove ImagesCreate Series Template	Mount ImagesMove within MountCreate a Mount	Mount ImagesMove within MountCreate a Mount
Image Search Available	Yes	Same	Same
Image Storage	Original data unaltered	Original data unaltered	Original data unaltered
	Lossless compression ofradiographic images	Lossless/lossycompression	Lossless/lossycompression
	Full history of enhancementsrecorded with each image	History of operations	History of operations
Database Storage	Microsoft SQL Server database	File System	File System
Database Software	Microsoft SQL Server 2005 orhigher	File System	File System
Comparison Areas	IMPROVIS Imaging	Visix Imaging	TigerView Professional
Image Viewing	Zoom In and Out	Zoom In and Out	Zoom In and Out
	Full Screen	Full Screen	Full Screen
	Scale to 100%	Reset Zoom	Reset Zoom
	Rotate 90 or 180 degrees	Rotate 90° or 180°	Rotate 90° or 180°
	Flip Left to Right	Flip Left to Right	Flip Left to Right
	Flip Top to Bottom	Flip Top to Bottom	Flip Top to Bottom
	Rotate 0 Degrees	Reset Orientation	Reset Orientation
Image Measurement	Line	Line	Line
	Angle	Angle	Angle
	Calibrate	Calibrate	Calibrate
	Line ColorShow/Hide	Line ColorShow/Hide	Line ColorShow/Hide
Image Annotation	Line	Line	Line
	Free Line	Freehand	Freehand
	Circle	Circle	Circle
	Rectangle	Square	Square
	Arrows	Arrows	Arrows
	Text	Text	Text
	Color	Color	Color
	Width	Width	Width
	Show/Hide	Show/Hide	Show/Hide
Image Operations	Magnifier	Magnifying Glass	Magnifying Glass
	Print	Print	Print
	Negative	Negate	Negate
	Colorize	Colorize	Colorize
	Emboss	Pseudo 3D	Pseudo 3D
	Sharpen	Sharpen Edge	Sharpen Edge
	Original Image	Original Image	Original Image
	Brightness	Brightness	Brightness
	Contrast	Contrast	Contrast
	Gamma	Gray Shift (Gamma)	Gray Shift (Gamma)
Security	Login, admin, and feature access	Login and admin	Login and admin

ﺮ ﺍ

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and the comments of the comments of the comments of

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Image /page/5/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an abstract image of an eagle.

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

American Dental Partners, Inc. % Mr. Timothy Rodenberger General Counsel 401 Edgewater Place, Suite 430 WAKEFIELD MA 01880-6225

NOV 1 0 2010

Re: K101654 Trade/Device Name: Improvis® Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 29, 2010 Received: September 29, 2010

Dear Mr. Rodenberger:

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,

Dan

David G. Brown, Ph.D. Acting 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

510(k) Number (if known): K101654

NOV 1 0 2010

Device Name: Improvis® Imaging System

Indications for Use:

Improvis Imaging is written using three programming languages (C++, C#, TSQL) and is designed to work with standard personal computers capable of running Windows 2000 or higher.

Intended users of this system are trained professionals, including but not limited to dentists, hygienists and clinical assistants.

Prescription Use X (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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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).