Use as a software for the display and 3D visualization of dental image files from scanning devices such as CT, MRI for radiologists, dental clinicians and practitioners to acquire, process, render, review, store, print and distribute DICOM 3.0 complaint image studies, utilizing standard PC hardware.

Device Description

Accurex™ is a dental imaging software which loads DICOM images taken from CT. MR and provides 3D visualization, 2D image reformation and various diagnosis tools for dentists on PC, laptop or PACS Workstation. Dentists can do further precise and accurate pre/post-operative diagnosis by using advanced image reformation and generation functionality of Accurex™ such as Panoramic image and Cephalometric x-ray imaqe as well as 3D volume rendering image.

AI/ML Overview

The provided 510(k) summary for CyberMed, Inc.'s Accurex device (K061126) focuses on demonstrating substantial equivalence to predicate devices (V-works and Vimplant) based on its functional description and intended use. It does not contain information about specific acceptance criteria, a formal study design the proves the device meets the acceptance criteria (beyond functional testing), reader performance, or detailed ground truth establishment for a test set.

Therefore, I cannot populate the requested table and details regarding a specific study proving acceptance criteria. The document primarily describes the device's features and its compliance with DICOM 3.0 standards, comparing it generally to predicate devices in terms of functionality for image processing and visualization in a dental context.

However, I can extract information related to the device's capabilities and its intended use, which inherently imply certain functional acceptance.

Here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no specific quantitative acceptance criteria or reported performance metrics (like sensitivity, specificity, accuracy, or reader agreement statistics) are provided in the document. The document asserts the device's functionality and substantial equivalence to previously cleared devices.

Acceptance Criteria Category (Inferred)	Specific Criteria (Inferred/Missing)	Reported Device Performance (Missing/Inferred)
DICOM 3.0 Compliance	Ability to load, store, display DICOM 3.0 data	"The Accurex™ 2.0 is adaptable technically for all data of DICOM 3.0."
Image Display & Manipulation	Correct display of 2D/3D images, basic operations (pan, zoom, rotate, WL)	Functionality described: CINE player, 2D/3D manipulation tools. Implied to perform correctly.
Image Reconstruction & Generation	Accurate Panoramic, Cross-sectional, MPR, 3D volume rendering, MIP/MinIP, Cephalometric x-ray image generation	Functionality described. Implied to perform as intended for "accurate anatomical knowledge."
Nerve Creation & Display	Ability to draw nerve lines and display intersections	Functionality described. Implied to perform correctly.
Reporting & Measurement	Capability to generate reports, perform 2D/3D measurements	Functionality described. Implied to perform correctly.
File Format Support	Load DCM, save as DCM, BMP, JPG	Specified.
Safety & Effectiveness	General safety and effectiveness for intended use.	Concluded to be "safe and effective and substantially equivalent to predicate devices."

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

Sample Size: Not specified.
Data Provenance: Not specified. The document mentions loading DICOM images from CT/MR devices, but does not detail the origin or nature of data used for any testing.
Retrospective/Prospective: Not specified.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No, an MRMC study is not mentioned or implied. The device is described as an image processing and visualization tool, not an AI diagnostic aid that would directly assist human readers in interpretation or improve their performance. The purpose is to provide "further precise and accurate pre/post-operative diagnosis" by enabling the practitioner to view and manipulate images.

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

Standalone Performance: Not explicitly detailed with performance metrics. The document describes the algorithm's capabilities (e.g., 3D image construction via Volume Rendering) and states that "3D Algorithm was cleared in Vworks((K013878)." This implies that the core 3D processing algorithms underwent some form of validation in the predicate device, but specific standalone performance metrics for Accurex are not provided.

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

Type of Ground Truth: Not specified in relation to any formal testing or validation within this document. The device is a display and processing software, implying that the "ground truth" would relate to the accuracy of image rendering, measurements, and reformations compared to the source DICOM data and established imaging principles, rather than a diagnostic outcome.

8. The sample size for the training set

Training Set Sample Size: Not applicable. The document describes image processing software, not a machine learning or AI algorithm that would typically require a "training set" in the conventional sense for a diagnostic model. While algorithms might have been developed using data, a dedicated "training set" for a submitted AI model is not indicated.

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

Ground Truth Establishment for Training Set: Not applicable, as no training set for an AI model is indicated.

Summary

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K061126

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: _ Mar. 15, 2006

PAY - 9 1005

Company and Correspondent making the submission:

Name - CyberMed, Inc.

Address - #504 SJ Technoville, Gasan-dong 60-19, Geumcheon-gu, Seoul, 153-710, Korea

Telephone -- +82-2-3397-3970

Fax - +82-2-3397-3971

Contact - Mr. Song Nak Choi/ Manager

Device :

Trade/proprietary name	: Accurex
Common Name	: 3D dental image processing software
Classification Name	: Picture archiving and communications system

Predicate Devices :

Manufacturer:	CyberMed, Inc.
Device:	V-worksTM
510(k) Number:	K013878 (Decision Date - 12/07/2001)

Manufacturer:	CyberMed, Inc.
Device:	Vimplant
510(k) Number:	K053155 (Decision Date - 11/23/2005)

1. Classifications Names & Citations :
  21CFR 800.2050, LLZ, Picture archiving and communications system, Class2

CyberMed, Inc.

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1. Description :
- 1. General Description

Dentists can do further precise and accurate pre/post-operative diagnosis by using advanced image reformation and generation functionality of Accurex™ such as Panoramic image and Cephalometric x-ray imaqe as well as 3D volume rendering image.

1. Main Function
(1) DICOM 3.0 data Compliance and Management

Users can import DICOM 3.0 data taken from scanning devices such as CT, MRI to the Accurex™'s database. The Accurex™ supports to load different types of DICOM images such as 8/12/16 bits gray images and color images. The imported DICOM images can be stored in Master database, Local databases or Remote PACS servers on intuitive user interface such as Windows Explorer. The Accurex™ supports to make multiple Local databases so it is very convenient for multiple users on one system. Also the Accurex™ supports CD-R/RW to keep necessary DICOM images in CD directly.

(2) Image Display
The Accurex™ supports to load different types of DICOM images such as 8/12/16 bits gray images and color images. And Accurex™ provides "CINE Player to display multi-frame DICOM images and also supports a preview image on Window print and DICOM print screen.
(3) Basic Operation
The Accurex™ provides some tools for basic image operation. As 2D image operation tools, it provides Window Level adjusting, Panning, Rotation, Flip, Inverting and High-quality Plane zoom. And As 3D image operation tools, it provides Rotation, Panning, Zooming and High-quality 3D zoom.
(4) 2D image reformation
The Accurex™ has the capability of reformatting Panoramic images and Cross-

CyberMed, Inc.

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sectional images as well as basic MPR(Multi-Planar Reformation), thickness MPR, Oblique MPR. Also Accurex™ can generate some radiographic images such as Panoramic x-ray image and Cephalometric x-ray image. So dental practitioners can get the accurate anatomical knowledge of the patient on each view and it helps them to do precise diagnosis.

(5) 3D image construction

The Accurex™ has the capability of constructing 3D model from original axial images. The method of 3D image construction is Volume rendering. And multiple volume rendering is supported. The volume rendering image can be manipulated by CT value, Color, Opacity, Window Level and width value and also can be edited by CT value threshold and 3D cutting tool. And Virtual Endoscopy is supported. Also the Accurex™ supports high-quality zoom function for studying some subtle and fine structures with better quality of volume rendering model. 3D Algorithm was cleared in Vworks((K013878).

(6) Image projection

The Accurex™ can generate some projection images such MIP(Maximum Intensity Projection), MinIP(Minimum Intensity Projection), Ray-sum image.

(7) Nerve Creation and Display

The Accurex™ has nerve creation function. Users can draw a nerve line on crosssectional and panoramic images as well as axial images, And then users can see the intersection shape of nerve on each view.

(8) Report

The Accurex™ provides a report template. The report template makes it possible to help some results or opinion for diagnosis. Users can capture some necessary images on all screens with Pane-Capture or Region-Capture options and insert the captured images to their report. So users can make their unique report more quickly and easily as intuitive user-familiar interface. Also the report can be exported to HTML or XML format document.

(9) Measurement

The Accurex™ provides users needful measurement functions. Users can use 2D

CyberMed, Inc.

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measurement tools such as distance, and area, CT value profile and 3D measurement tools such as distance, angle.

(10) Capture and Print

The Accurex™ has a capability of image capture. The captured images can be print by Window printer and DICOM printer.

Information of the image format

The Accurex™ can load only DCM files and save results as DCM, BMP and JPG files.

DCM : DICOM (Digital Image Communication in Medicine) is a Standard Protocol to exchange and transfer the data acquired by Medical Image devices such as a CT, MR, 3D US, etc. It is designated as a Standard Protocol by ACR-NEMA (American College of Radiology-National Electrical Manufacturers Association) and now adopted by most Medical Imaging Devices. The Accurex™ 2.0 is adaptable technically for all data of DICOM 3.0.

Reference : Digital Imaging and Communications in Medicine (DICOM) ACR-NEMA Standards Publication PS 3.1~PS 3.16 2003.

BMP : The standard bit-mapped graphics format used in the Windows environment. By convention, graphics files in the BMP format end with a BMP extension. BMP files store graphics in a format called device-independent bitmap (DIB).
· JPG/JPEG : Short for "Joint Photographic Experts Group", the original name of the committee that wrote the standard. JPG is one of the image file formats supported on the Web. JPG is a lossy compression technique that is designed to compress color and grayscale continuous-tone images, but the Accurex™ does not compress original graphics any more, that is to say lossless compression.

JPG images support 16 million colors and are best suited for photographs and complex graphics.

Indication for use :

CyberMed, Inc.

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1. Comparison with predicate device :
  CyberMed, Inc., believes that the Accurex 3D dental image processing software is substantially equivalent to Vworks of CyberMed, Inc..
1. Conclusions :
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification CyberMed, Inc. concludes that Accurex is safe and effective and substantially equivalent to predicate devices as described herein.
1. CyberMed, Inc. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

CyberMed, Inc.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY - 9 2005

CyberMed, Inc. % Mr. Marc M. Mouser Senior Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WASHINGTON 98607

Re: K061126

Trade/Device Name: Accurex Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 5, 2006 Received: April 24, 2006

Dear Mr. Mouser:

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 (Premarket Approval), it may be subject to such 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.

Image /page/5/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular and contains the text "1906-2006" at the top and "FDA Centennial" in the center. The text "Protecting and Promoting Public Health" is written in a decorative font below the logo. The logo also includes three stars.

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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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon 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

KOGIIZE 510(k) Number(if known):

Device Name: Accurex

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

ー

AND/OR

Over-The-Counter Use_ (Part 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)

Page 1 of _1

David A. Seymour

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061126

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).