Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US. PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.

Device Description

XELIS 3D is a software package intended for viewing and manipulating DICOMcompliant medical images from CT (computerized tomography), PET (positron emission tomography) or MRI (magnetic resonance imaging) scanners and other imaging modalities. XELIS 3D can be used for real-time viewing, 3D volume rendering, segmentation, registration, and reporting.

XELIS 3D application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990.

XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes.

XELIS 3D is supplied to end users in both Windows 32 bit and 64 bit operating systems. The device software can connect to other workstations, PACS server/software, and modalities, through DICOM communication standard.

AI/ML Overview

The provided text describes the XELIS 3D software, a picture archiving and communications system, and its substantial equivalence to predicate devices. However, it does not contain specific details regarding acceptance criteria and a structured study with quantifiable performance metrics. Instead, it focuses on demonstrating that XELIS 3D performs as intended and is as safe and effective as its predicate devices.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance Study for XELIS 3D

The XELIS 3D is a software package intended for viewing and manipulating DICOM-compliant medical images. The submission for its 510(k) clearance emphasizes its substantial equivalence to predicate devices rather than presenting a comparative effectiveness study with specific quantified acceptance criteria and performance metrics against a defined ground truth.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific, quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or any task-specific performance measures. Instead, the acceptance criteria are described in more general terms related to system functionality and safety.

Acceptance Criteria Category	Reported Device Performance Summary
Functional Verification	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 3D software in each operational mode. Validation testing indicated that all verification and validation activities were performed by designated individuals, and the results demonstrated that the predetermined acceptance criteria were met.
Integration & Installation	When installed by INFINITT CO., LTD, integration and installation verification tests are conducted against acceptance criteria prior to release to the client. The results are provided in the 510(k) submission.
Safety and Effectiveness	The device is described as "as safe, as effective, and performs as well as the predicate devices." It does not contact the patient, nor does it control any life-sustaining devices. Diagnosis is performed by Radiologists, Clinicians, and referring Physicians, with ample opportunity for competent human intervention. It is deemed not to raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.
DICOM Conformance	The XELIS 3D application conforms to the DICOM 3.0 standard. (Ensures interoperability with other DICOM compliant systems).
Operating Systems	Supplied to end users in both Windows 32-bit and 64-bit operating systems.
Clinical Limitations	Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis. For primary diagnosis, post-process DICOM "for presentation" images must be used. Mammographic images should only be viewed with an FDA-approved monitor for mammographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application. (These are conditions of use rather than performance metrics, but they define acceptable clinical performance boundaries).

2. Sample Size and Data Provenance (Test Set)

The document does not provide specific details on the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data. The testing described is "in-house testing criteria" and "validation testing" which seem to refer to internal software quality assurance rather than a clinical performance study with a distinct test set of patient cases.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

This information is not provided in the document. The text indicates that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians," implying that human experts are responsible for interpretation, but it does not specify how ground truth was established for any performance evaluation in the context of the device's 510(k) submission.

4. Adjudication Method (Test Set)

An adjudication method (e.g., 2+1, 3+1) for establishing ground truth on a test set is not mentioned in the provided text, as a specific clinical test set for performance evaluation is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information regarding the effect size of how much human readers might improve with or without AI assistance, as the device primarily functions as a viewing and processing tool, not an AI-assisted diagnostic aid for detection. The text explicitly states: "XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes."

6. Standalone Performance Study (Algorithm Only)

A standalone performance study of the algorithm without human-in-the-loop performance is not described. Given the device's function as an imaging workstation and its statement that "Diagnosis is not performed by the software," a standalone study for diagnostic performance would not be applicable or expected. The testing described focuses on functional verification of the software.

7. Type of Ground Truth Used

The type of ground truth used (e.g., expert consensus, pathology, outcomes data) for any performance evaluation is not specified. The regulatory submission focuses on demonstrating functional equivalence and safety rather than a diagnostic performance study against a clinical ground truth.

8. Sample Size for the Training Set

The document does not provide information on a training set size. As the XELIS 3D does not perform automated detection or analysis (i.e., it doesn't describe AI/ML functionality requiring a training set), this information would not be relevant in this particular submission.

9. How Ground Truth for Training Set Was Established

Similarly, since there's no mention of a training set for an AI/ML algorithm, the method for establishing ground truth for a training set is not discussed.

In summary, the 510(k) submission for XELIS 3D demonstrates substantial equivalence primarily through functional verification, safety assessments, and conformance to standards (like DICOM 3.0), rather than through a clinical performance study with defined quantifiable acceptance criteria against a clinical ground truth. The device is presented as an image viewing and manipulation tool, not an automated diagnostic system, hence many of the requested elements pertaining to AI/ML performance studies are not present or applicable in this context.

Summary

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JUL 28 2011

103130

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

Date Prepared: June 1, 2011

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: +82-2-2194-6673 Fax: +82-2-2194-1698

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	XELIS 3D
Common Name:	Picture Archiving Communications System
Classification Name:	system, image processing, radiological
Product code:	LLZ
Device Classification:	892.2050

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

510(k) Number	K082990	K070831
Device Classification Name	System, imageprocessing, radiological	System, imageprocessing, radiological
Device Name	INFINITT XELIS	Voxar 3D Enterprise withColonMetrix and PET/CTPerfusion
Applicant	INFINITT CO., LTD	BARCOVIEW MISEDINBURGH
Regulation Number	892.2050	892.2050
Classification Product Code	LLZ	LLZ
Decision Date	11/20/2008	05/22/2007
Classification AdvisoryCommittee	Radiology	Radiology
Type	Traditional	Traditional

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

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510(k) Summary of Safety

XELIS 3D application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems and is based upon the predicate device software used in Infinitt Xelis K082990.

XELIS 3D does not include any automated or semi-automated process for the detection of nodules or other shapes.

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

Xelis 3D™ is a software device intended for viewing of images acquired from various imaging modalities: CT. MR. CR. DR. US, PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

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

XELIS 3D is 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.

A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.

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 3D software in each operational mode and followed the process documented in the System Validation Test Plan.

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.

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510(k) Summary of Safety

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. results are provided in the 510(k)

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

The 510(k) Pre-Market Notification for XELIS 3D contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The subject device 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 does not raise any new potential safety risks 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 3D is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.

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 1285 Walt Whitman Rd. MELVILLE NY 11747

JUL 2 8 2011

Re: K103130

Trade/Device Name: Xelis 3DTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 29, 2011 Received: July 1, 2011

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,

Mary Patel

Mary S. Pastel. Sc.D. 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): K / / 3 / 30

Device Name: Xelis 3D™

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 In Vitro Diagnostic Devices (OIVD)

Mohd. O'Khas

Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K103130
Page 1 of

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).