The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

Device Description

The DEXIS Software is a software program for general dental and maxillo-facial diagnostic imaging. It controls capture, display, enhancement and saving of x-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intraoral or extraoral dental cameras. DEXIS Software allows the following functionality:

Control scanning and intake of x-ray images from imaging plates with the DenOptix scanner.
Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S. KaVo Dig eXam, Orthoralix DPI & DDE series systems.
View and capture color images from certain cameras, such as dental camera, via a suitable video capture card.
Export and import digital images (such as those obtained by scanning a film) in several standard file formats.
Process images with dental specific tools, to enhance their diagnostic value.
Analyze and manipulate images in order to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
Create a database of patients and easily store images in patient folders.

AI/ML Overview

This document is a 510(k) summary for the DEXIS Software, dated February 4, 2009. It describes the software's functionality and its intended use as a dental imaging device. The submission claims substantial equivalence to two predicate devices: DEXIS Model 601 (K962631) and Gendex Dental Systems, VixWin Pro (K060178).

Based on the provided text, there is no specific study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics. This 510(k) submission is for a software update to an already cleared device, focusing on technical changes (rewritten in 32-bit code for newer Windows versions) rather than a novel diagnostic algorithm. The acceptance criteria and "device performance" in this context are related to demonstrating that the modified software maintains the same intended use and technical characteristics as the predicate devices and the original cleared version of DEXIS Software.

Here's an attempt to extract the requested information, noting where details are not present in the provided document:

Acceptance Criteria and Device Performance for DEXIS Software (K090431)

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission as a software update and re-affirmation of substantial equivalence, the "acceptance criteria" are implied by the claim of maintaining the same intended use and technical characteristics as predicate devices. The "reported device performance" is the statement that these characteristics have been retained despite the software rewrite.

Acceptance Criterion (Implied)	Reported Device Performance
Intended Use Equivalence: The modified software performs the	"There will be no change to the intended use..."
same functions for general dental and maxillofacial diagnostic	"The DEXIS Software is substantially equivalent in
imaging as the predicate devices. This includes controlling	intended use...as the VixWin Pro software..."
capture, display, enhancement, and saving of X-ray digital images,
and handling other image types.
Technical Characteristic Equivalence: The modified software	"...no change to the technical characteristics."
maintains the core functionalities related to image acquisition,	"The DEXIS Software is substantially equivalent in
processing, analysis, manipulation, and database management	...technical characteristics as the VixWin Pro software."
as the predicate devices.
Backward Compatibility: The modified software retains	"The modified device also retains 'backward
compatibility with earlier versions.	compatibility' with earlier versions including
	Windows® 98, NT and non-upgrade versions of ME."
Operating System Compatibility: The software is compatible	"The modified DEXIS Software has been rewritten in
with specified operating systems.	32-bit code and will now run in 'native' format with
	Microsoft® Windows XP® (home or professional) and
	Windows® 2000."

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

The document does not specify a test set sample size or data provenance for any performance evaluation directly related to this 510(k) submission. As this is a software update for an already cleared device, the submission focuses on compatibility and equivalence rather than new performance data from a specific test set.

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

The document does not mention using experts to establish ground truth for a test set, as no specific performance study is detailed.

4. Adjudication method for the test set

The document does not mention any adjudication method, as no specific performance study is detailed with a test set.

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 MRMC comparative effectiveness study was done or reported in this 510(k) submission. The DEXIS Software, as described, is a dental imaging management system, not an AI-assisted diagnostic tool providing interpretations that would typically be evaluated in an MRMC study comparing human performance with and without AI.

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

No standalone algorithm performance study was mentioned or reported. The software's function is to control, display, enhance, and save images for human interpretation, not to provide independent diagnostic outputs.

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

The document does not describe the use of ground truth data for performance evaluation in this 510(k) submission. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that their prior clearance (which would have involved demonstrating performance appropriate for their intended use) serves as the "ground truth" for the current device's capabilities.

8. The sample size for the training set

The document does not mention a training set sample size. As this primarily describes an update to an existing imaging software, not a machine learning or AI algorithm development, a "training set" in that context would not be applicable.

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

Not applicable, as no training set (in the context of machine learning/AI) is mentioned.

Summary of Filing Focus:

This 510(k) submission (K090431) for the DEXIS Software primarily serves as an update to an already cleared medical device (K962631). The key points for its clearance are:

The software has been rewritten into 32-bit code for compatibility with newer operating systems (Windows XP, 2000).
It retains "backward compatibility" with earlier Windows versions.
Critically, it asserts "no change to the intended use or technical characteristics" compared to its previously cleared version and the identified predicate devices (DEXIS Model 601 and Gendex VixWin Pro).

The FDA's review and clearance of this 510(k) is based on the claim of substantial equivalence, meaning the updated software is as safe and effective as the predicate devices, without requiring new clinical or performance studies that would typically involve specific acceptance criteria, test sets, experts, or ground truth establishment for novel diagnostic claims.

Summary

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K090431
Page 1 of 2

Image /page/0/Picture/1 description: The image shows a logo for Sydron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYDRON DENTAL SPECIALTIES' are written in a smaller font. The logo appears to be for a dental company.

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

JUN 2222009

Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person

Date Summary Prepared: February 4, 2009

Device Name:

Trade Name DEXIS Software .
Common Name Dental Imaging Device .
Classification Name Picture Archiving and Communication Systems, per 21 CFR § . 892.2050.

Devices for Which Substantial Equivalence is Claimed:

Fair Image, Inc., (now owned by DEXIS, LLC.), DEXIS Model 601 (K962631) .
Gendex Dental Systems, VixWin Pro (K060178) .

Device Description:

Control scanning and intake of x-ray images from imaging plates with the * DenOptix scanner.
Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-. S. KaVo Dig eXam, Orthoralix DPI & DDE series systems.
View and capture color images from certain cameras, such as dental camera, via a . suitable video capture card.
Export and import digital images (such as those obtained by scanning a film) in . several standard file formats.
Process images with dental specific tools, to enhance their diagnostic value. •
Analyze and manipulate images in order to gather additional diagnostic . information which may not be immediately apparent on initial visual inspection.
Create a database of patients and easily store images in patient folders. .

1717 West Cullins Avenue, Orange, CA 92867 800-537-7824 714-516-7400

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K890431
Page 2 of 2

Intended Use of the Device:

Substantial Equivalence:

The DEXIS Software is an existing device which was granted market clearance by the FDA following the submission of a 510(k) pre-market notification (K962631). The modified DEXIS Software has been rewritten in 32-bit code and will now run in 'native' format with Microsoft® Windows XP® (home or professional) and Windows® 2000. The modified device also retains 'backward compatibility' with earlier versions including Windows® 98, NT and non-upgrade versions of ME. There will be no change to the intended use or technical charactcristics.

The DEXIS Software is substantially equivalent in intended use and technical characteristics as the VixWin Pro software marketed by Gendex Dental Systems (K060178).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 222009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEXIS LLC

%Ms. Claudia Ortiz Compliance Director, Regulatory Affairs & Quality Assurance Sybron Dental Specialties 1717 West Collins Avenue ORANGE CA 92867

Re: K090431

Trade/Device Name: DEXIS Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 27, 2009 Received: June 2, 2009

Dear Ms. Ortiz:

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 (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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrb/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Acting 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

510(k) Number (if known):

Device Name: DEXIS Software

Indications for Use:

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 Device Evaluation (ODE)

fori mthey

f Reproductive, Abdominal,
ological Devices
Number: K090431

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રજુના

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).