The Xeron PACS is a medical imaging software application intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.

Device Description

Xeron PACS is an image management system that allows authorized personnel to acquire, display, edit, review, store, print, and distribute standard Digital Imaging and Communications in Medicine (DICOM) medical images within a Picture Archiving and Communication System (PACS) environment. The Xeron PACS system consists of five software components:

· XP WebStation
· XP RadStation
· XP Site Administrator
· XP Data Router
· XP Server Manager
Xeron PACS supports DICOM network structures which allow for efficient medical image acquisition from any medical modality, including CT, MR, CR, and others. Distribution of images is provided to desktop computer systems, computer systems connected by intranet or internet, hardcopy devices, and Hospital Information Systems (HIS).

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document, K062757, is a 510(k) Premarket Notification for the "Xeron PACS" system. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a detailed clinical study with performance metrics.

Based on the information given, the document does not contain explicit acceptance criteria or a detailed study report that proves the device meets specific acceptance criteria in the manner typically seen for performance claims (e.g., sensitivity, specificity, or reader improvement).

Instead, the submission focuses on:

Device Description: What the device is and what it does.
Intended Use: The purpose and scope of the device.
Technological Comparison: How it is similar to the predicate device.
Testing: A very general statement that says "Xeron PACS has been demonstrated to perform as intended."
Conclusion: That it is substantially equivalent to legally marketed Image Processing Systems (PACS).

Therefore, many of the requested details about acceptance criteria and study parameters cannot be extracted from this specific 510(k) summary.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or quantitative performance metrics are provided in the document. The "performance" demonstrated is a general claim of "performing as intended" and being "substantially equivalent" to a predicate PACS system. PACS systems are infrastructure devices, and their "performance" often relates to data handling, display capabilities, and adherence to standards (like DICOM), rather than diagnostic accuracy metrics.

Acceptance Criteria	Reported Device Performance
Not specified in this document. The submission focuses on demonstrating substantial equivalence to a predicate PACS system (GE Centricity PACS) for its intended use of image display, editing, review, storage, printing, and distribution.	"Xeron PACS has been demonstrated to perform as intended." (General statement, no quantitative metrics).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

Given the nature of a PACS system, the "test set" would likely refer to a set of DICOM images used to verify its functionality (acquisition, display, storage, distribution). However, the document does not elaborate on this.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

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

Establishing "ground truth" with expert consensus is typically relevant for interpretative AI/CAD devices. For a general PACS system, ground truth would relate to the integrity and accurate display of the medical images themselves, which usually doesn't require expert consensus in the same way.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

This is not applicable as no expert-adjudicated test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC study was not done (or at least not reported in this summary). The document does not describe any studies involving human readers or comparative effectiveness with or without AI assistance.
Effect Size of Human Reader Improvement: Not applicable, as no such study was conducted.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Study: Not explicitly described in terms of diagnostic performance metrics for an algorithm. The "testing" mentioned is likely functional and performance testing of the software system as a whole, addressing its ability to acquire, store, display, and distribute images, rather than a standalone diagnostic algorithm performance study.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For a PACS system, "ground truth" would generally refer to the correct and compliant handling of DICOM images and associated metadata, and the accurate representation of image data. This is typically verified through technical validation against DICOM standards and internal functional specifications. Medical "ground truth" from pathology or outcomes data is not relevant for a general PACS device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The Xeron PACS is described as an "image management system" and "software application," not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established for Training Set: Not applicable, as there is no apparent training set for an AI/ML algorithm.

Summary of Missing Information:

The provided 510(k) summary for Xeron PACS is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It does not provide the detailed performance study information common for AI/CAD devices or devices with specific diagnostic claims. The "testing" mentioned is a general statement, and no specific acceptance criteria, sample sizes for medical image sets, expert qualifications, or ground truth methodologies for diagnostic purposes are presented.

Summary

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K062757

510(k) Premarket Notification

Page 1 of 2

510(k) SUMMARY

NOV - 7 2006

General Information

Submitted by:	XERON Healthcare Corp.A-206 Hi-Tech Venture Center, 647-26Deungchon-Dong, Gangseo-GuSeoul, KoreaPhone: +82 2 3663 8424Fax: +82 2 3663 8426
Contact Person:	Mr. Douglas KimA-206 Hi-Tech Venture Center, 647-26Deungchon-Dong, Gangseo-GuSeoul, KoreaPhone: +82 2 3663 8424Fax: +82 2 3663 8426Email: douglas_kim@xeron.co.kr
Date Prepared:	September 11, 2006

Device Name

Trade Name:	Xeron PACS
Common Name:	Picture Archiving and Communications System
Classification Name:	System, Image Processing, Radiological,
	21 CFR 892.2050

Predicate Device

Manufacturer	Product Name	510(k) No.
GE Medical SystemsInformation Technologies	GE Centricity PACS	K043415

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Device Description

· XP WebStation
· XP RadStation
· XP Site Administrator
· XP Data Router
· XP Server Manager

Xeron PACS supports DICOM network structures which allow for efficient medical image acquisition from any medical modality, including CT, MR, CR, and others. Distribution of images is provided to desktop computer systems, computer systems connected by intranet or internet, hardcopy devices, and Hospital Information Systems (HIS).

Intended Use

Technological Comparison

Xeron PACS and GE Centricity PACS are software applications that have similar indications for use and overall function and perform in a similar manner with respect to image processing systems (i.e. PACS).

Testing

Xeron PACS has been demonstrated to perform as intended.

Conclusions

Xeron PACS is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three parallel lines that curve and merge together, forming a shape that could be interpreted as a stylized human figure or a flame.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

XERON Healthcare Corp. % Mrs. Melissa Mahall Director, Regulatory Affairs Bio-Reg Associates, Inc. 6304 Belmont Circle, Bldg 2 MOUNT AIRY MD 21771

NOV - 7 2006

Re: K062757

Trade/Device Name: Xeron PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 11, 2006 Received: September 20, 2006

Dear Mrs. Mahall:

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/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a circular border.

Protecting and Promoting Public Health

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Page 2 -

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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

510(k) Number (if known):

K1062757

Device Name: Xeron PACS

Sponsor Name: XERON Healthcare Corp.

Indications for Use:

Prescription Use XI (21 CFR 801 Subpart D)

Over-The-Counter Use | | (21 CFR 807 Subpart C)

Do Not Write Below This Line – Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

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).