Imagecast™ PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

Device Description

The Imagecast™ PACS is a modification of the iSite PACS that replaces the iSite worklist software with the Imagecast™ Worklist software. The Imagecast™ PACS is designed to optimize the clinician's workflow, and targets activities fundamental to their work: organizing, finding, reading, sharing and reporting. The Imagecast™ PACS trade name is also currently in use by IDX to resell the iSite PACS product.

AI/ML Overview

The provided text describes the Imagecast™ PACS (Picture Archiving and Communication System), a modification of the iSite PACS. However, it does not contain a study with detailed acceptance criteria and performance metrics in the way a clinical superiority or non-inferiority study would.

Instead, the document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, not on proving new performance claims with specific acceptance criteria and detailed study results.

Here's an analysis based on the available information, noting what isn't present based on your request:

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

Acceptance Criteria: The document states, "Prospectively defined verification and validation activities for the Imagecast™ PACS assure that the Imagecast™ PACS is substantially equivalent to the cleared iSite PACS and meets design and performance specifications as well as user needs when operated according to the operating instructions."
- Interpretation: The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to the predicate device (iSite PACS, K042292) in terms of intended use, indications for use, technological characteristics, and operational characteristics. Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task) are not provided nor required for this type of clearance, as it's not a new diagnostic algorithm.
Reported Device Performance: No specific numerical performance results (e.g., sensitivity, specificity, or image quality metrics) are reported in this document. The "performance testing" section broadly refers to "verification and validation activities" that assure substantial equivalence and meeting design/performance specifications.

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

Not provided. The document does not describe a clinical test set or data specific to evaluating the Imagecast™ PACS's diagnostic performance. The "performance testing" mentioned is likely focused on system functionality, integration, and user interface, demonstrating that the modifications (replacing iSite worklist with Imagecast™ Worklist) do not negatively impact the system's core PACS functionality or safety.

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 provided. Since there's no diagnostic performance study described, there's no mention of experts establishing ground truth for a test set.

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

Not applicable/Not provided. (See point 3).

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, an MRMC study was NOT done. The Imagecast™ PACS is described as an "image management system," a Picture Archiving and Communication System (PACS) with a modified worklist software. It is not an AI diagnostic tool or an AI-assisted reading system designed to improve human reader performance. Therefore, an MRMC study for AI assistance is not relevant to this device's clearance.

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

No, a standalone algorithm performance study was NOT done. The Imagecast™ PACS is a system for image management, transmission, processing, and storage, not a standalone diagnostic algorithm.

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

Not applicable/Not provided. (See point 3).

8. The sample size for the training set

Not applicable/Not provided. This device is an image management system with modified worklist software, not an AI algorithm that requires a training set of medical images.

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

Not applicable/Not provided. (See point 8).

Summary of what the document does state regarding performance:

The core of the "Performance Testing" section (Section 7) is a statement of assurance:

"Prospectively defined verification and validation activities for the Imagecast™ PACS assure that the Imagecast™ PACS is substantially equivalent to the cleared iSite PACS and meets design and performance specifications as well as user needs when operated according to the operating instructions."

This indicates that the manufacturer performed internal testing (verification and validation) to ensure the modified PACS system functions as intended and safely, and that these activities supported the claim of substantial equivalence to the predicate device. For a PACS system, such testing would typically cover aspects like:

Image acquisition and display integrity
Data transmission reliability and speed
Storage and retrieval functionality
Worklist management functionality and integration
System security
Compliance with standards (e.g., DICOM)
User interface functionality and usability

However, the specific metrics or detailed results of these verification and validation activities are not included in this high-level 510(k) summary. The FDA's clearance is based on the determination that these activities were sufficient to demonstrate substantial equivalence, not on a clinical performance study with specific diagnostic outcomes.

Summary

{0}------------------------------------------------

NOV 1 7 2005

510(k) Summary for the IDX Systems Corporation Imagecast™ PACS

1. SUBMITTER/HOLDER

K052618

IDX Systems Corporation 40 IDX Drive P.O. Box 1070 Burlington, VT 05402

Contact Person: Dan McKibben Telephone: 802-859-6003

Date Prepared: September 6, 2005

2. DEVICE NAME

Proprietary Name: Imagecast™ PACS Common/Usual Name: PACS Picture archiving and communication system Classification Name:

PREDICATE DEVICE 3.

iSite PACS System, K042292, Stentor, Inc.

4. DEVICE DESCRIPTION

ડ. INTENDED USE

Imagecast™ PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical

{1}------------------------------------------------

technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Imagecast™ PACS is substantially equivalent to the iSite PACS in intended use, indications for use, technological characteristics and operational characteristics.

7. PERFORMANCE TESTING

Prospectively defined verification and validation activities for the Imagecast™ PACS assure that the Imagecast™ PACS is substantially equivalent to the cleared iSite PACS and meets design and performance specifications as well as user needs when operated according to the operating instructions.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan McKibben Executive Quality Management Representative IDX IMAGECAST DIVISION 40 IDX Drive PO Box 1070 BURLINGTON VT 05402

Re .: K052618

Trade/Device Name: Imagecast PCS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: November 8, 2005 Received: November 9, 2005

Dear Mr. McKibben:

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 (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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

NOV 1 7 2005

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter natification. The FDA finding of substantial equivalence of your device to a legally premated 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 If you don't specifice 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 Alloy, production other general information on your responsibilities under the Act from the 601:37): " For may overnin sturers, 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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

KOSZ618

Imagecast™ PACS Device Name:

Indications For Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

Image /page/4/Picture/8 description: The image shows the text "AND/OR" with a line drawn through the word "AND". The text is in a simple, sans-serif font and is horizontally aligned. The slash between the words "AND" and "OR" is clearly visible. The line through "AND" suggests a negation or cancellation of that option.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Syverson

Page 4-1

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).