Xelis DENTAL is a software device that is intended to provide tools for the reading and review of a DICOM compliant series of medical imagers which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.

Xelis DENTAL is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction). These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.

Xelis DENTAL is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Device Description

Xelis Dental is a PC-based application used for storing and displaying medical images. The application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems. The implementation of Xelis Dental DICOM interface has been carefully tested to assure compliance with the DICOM Conformance Statement. However, the Conformance Statement and the DICOM standard do not guarantee interoperability of INFINITT's products and products of other vendors. The user must compare the relevant Conformance Statements and if a successful interconnection should be possible, the user is responsible to specify an appropriate test suite and to validate the required interoperability. A network environment may need additional functions out of the scope of DICOM.

Xelis Dental provides viewing of optimized images for 3D dental CT images. It comprises the following features.

3D VR, MPR, MIP, minIP .
MPR rotating, curve, 3D zoom .
Nerve (canal) drawing .
Dental implant simulation and bone-density analysis .
The subject device and the predicate devices are supplied to end users in both Windows 32 bit and 64 bit operations systems. XELIS DENTAL software can connect to other workstations, PACS server/software, and modalities, through the DICOM communication standard.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called XELIS DENTAL. However, it does not include information about acceptance criteria or specific studies to prove device performance against such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, general function, application, and intended use. It mentions nonclinical testing and validation but does not provide details on specific acceptance criteria or performance metrics.

Therefore, for most of your requested points, the information is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

Not Available: The document states that "predetermined acceptance criteria were met" during validation testing, but it does not specify what those criteria were or provide a table of performance results against them.

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

Not Available: The document mentions "nonclinical testing" and "validation testing" but does not describe any specific test set, its sample size, or data provenance.

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 Available: Since no specific test set or clinical study is described, there's no information on experts establishing ground truth for a test set. The device is a viewing and analysis tool, and diagnosis is performed by medical professionals, not the software.

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

Not Applicable / Not Available: No test set or clinical study with adjudication 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

Not Available: The document states, "Note: The subject device does not include any automated or semi-automated process for the detection of nodules or other shapes." This indicates that it's a visualization and analysis tool rather than an AI-driven diagnostic aid that would typically undergo MRMC studies to evaluate reader improvement.

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

Not Applicable / Not Available: Given the device's function as a viewing and analysis tool for medical professionals, and the explicit statement that it does not perform diagnosis or automated detection, a standalone performance study in the context of an "algorithm only" is not relevant or described. The device is intended to be used by humans.

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

Not Applicable / Not Available: As no specific performance study against a ground truth is reported, this information is not present. The device processes existing DICOM images; it does not generate diagnostic outputs requiring a ground truth for validation in the typical sense of a CAD system.

8. The sample size for the training set

Not Applicable / Not Available: The device is described as a software application for storing, displaying, and analyzing medical images. It does not appear to be an AI/machine learning model that would require a "training set."

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

Not Applicable / Not Available: As there's no indication of a training set, this information is not relevant or provided.

In summary: The provided document is a 510(k) summary focused on substantial equivalence demonstration for a medical image viewing and analysis software. It attests to internal nonclinical testing and validation meeting acceptance criteria, but it does not detail those criteria or the specific performance studies that would address most of your questions, which are typically relevant for AI/CAD devices or devices with specific diagnostic claims.

Summary

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510(k) Summary of Safety

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: May 17, 2010

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Submitter's Information: 21 CFR 807.92(a)(1) Mr. Tristan Choi, Program Manager INFINITT Co., Ltd. 12F Daerung Post Tower III, 182-4 Guro-dong, Guro-gu, Seoul, 152-050, Korea Tel: +82.2.2.2194.6673 Fax: +82.2.2194.1698

OCT * 1 2010

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) XELIS DENTAL™ Trade Name: Common Name: Picture Archiving Communications System system, image processing, radiological Classification Name: Product code: LLZ 892.2050 Device Classification:

Predicate Device: 21 CFR 807. 92(a)(3)

510(k) Number John Berg Bear Barry	K070464	K082990
evice Classification Name	system, imageprocessing, radiological	system, image processing,radiological
Device Name - 1 - 1 - 1 - 1 - 1 - 2 -	ONDEMAND3D	INFINITT XELIS
Applicant 3 3 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1	CYBERMED, INC.	INFINITT CO., LTD.
Regulation Number - - - - - - - -	892.2050	892.2050
Classification Product Code Sise	LLZ	LLZ
Decision Date - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1	03/16/2007	11/20/2008
Classification Advisory Committee	Radiology	Radiology
Type and the first to the country would be	Traditional	Traditional

Device Description: 21 CFR 807 92(a)(4)

Xelis Dental provides viewing of optimized images for 3D dental CT images. It comprises the following features.

3D VR, MPR, MIP, minIP .
MPR rotating, curve, 3D zoom .
Nerve (canal) drawing .

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Dental implant simulation and bone-density analysis .
The subject device and the predicate devices are supplied to end users in both Windows 32 bit and 64 bit operations systems. XELIS DENTAL software can connect to other workstations, PACS server/software, and modalities, through the DICOM communication standard.

Image /page/1/Figure/3 description: The image shows a diagram of a medical imaging network. The network includes several components, such as acquisition, storage, display, and network. The acquisition component includes CT and MR scanners. The display component includes Xella Workstation.

Indications for Use: 21 CFR 807 92(a)(5)

The Xelis DENTAL is a software device that is intended to provide tools for the reading and review of a DICOM compliant series of medical imagers which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.

Xelis DENTAL is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Technological Characteristics: 21 CFR 807 92(a)(6)

XELIS DENTALis a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Note: The subject device does not include any automated or semi-automated process for the detection of nodules or other shapes.

Nonclinical Testing:

The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the XELIS DENTAL software in each operational mode and followed the process documented in the System Validation Test Plan. The nonclinical testing results are provided in the 510(K).

Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by INFINITT Co., Ltd, integration and installations verification tests are conducted against acceptance criteria prior to release to the client.

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Conclusion: 21 CFR 807 92(b)(1)

The Pre-Market Notification for XELIS DENTALcontains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Any differences between the predicate devices and the subject device are not significant since they do not raise any new or potential safety risks to the user or patient and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate devices. Therefore, XELIS DENTAL is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring an abstract eagle-like figure with three curved lines extending from its body.

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

Infinitt Co., Ltd. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747

IOCT 1 2010

Re: K102684

Trade/Device Name: Xelis DENTAL Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 16, 2010 Received: September 17, 2010

Dear Mr. Conry:

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):

K102684

Device Name: Xelis DENTAL

Indications for Use:

Xelis DENTAL is not intended for use with or for the primary diagnostic interpretation of Mammography images.

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)

hul D. Thum G. David Brown

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K102684

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).