The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians.

Device Description

Carestream PACS, a multi-modality radiology reading and reporting station, provides support for 3D registration of studies taken at different times or by different modalities (CT and MRI), and for reading PET-CT images. The volumetric data sets are synchronized allowing the user to view reformatted series side by side and superimposed images. In all methods the algorithm is only using a rigid space transformation.

The registration in the "Volume Matching" application can be created by these methods:

. Register Studies

Full Automatic registration: The user is able to register two datasets by simply clicking on the windows that present these datascts, with no other additional input. The algorithm will not take into account the exact clicking points.

Manually Register Studies .
The user is able to "manually" register two datasets by providing additional inputs to the registration algorithm. The matching of the two volumes is done based on the planes of the two studies and on the position of the two clicking points. This input should be enough to match the two dataset. The user should try to click on the same anatomical location in both studies. while both planes are already swiveled to represent the same anatomical plane.
. Refine Registration
The user is able to adjust the registration. The refine algorithm is actually a local registration algorithm that tries to match two volumes based on local, rather than global, similarity. Practically, it can serve the user when he/she wants to focus on a certain region and to compare it in the two datasets. In such cases, local registration is preferable, even if it means that the global registration will be of a poorer quality.
Treat Studies as Registered .
The application supports the "treat studies as registered" feature - the ability for the user to select datasets / all datasets for which the system should treat as if they are fully registered to one another. This is needed to support places where although the data doesn't have the same frame of reference, they were registered in a "black-box" and only then copied to the PACS. The algorithm is ignoring the exact clicking point.

Reading PET-CT images require both specific image-manipulation capabilities and standardized uptake value presentation. PET scanning utilizes a radioactive molecule that is similar to glucose, called fluorodeoxyglucose (FDG). FDG accumulates within malignant cells because of their high rate of glucose metabolism, and is currently the radiotraccr most commonly used for PET' imaging.

The standardized uptake value (SUV) is a scmi-quantitative value that allows expression of FDG untake in a lesion relative to the injected dose. The standardized uptake value (SUV) is defined as the ratio of activity in tissue per millimeter to the activity in the injected dose per patient body weight.

AI/ML Overview

Here's an analysis of the provided text regarding the Carestream PACS, focusing on acceptance criteria and study details.

The provided document K083673 for Carestream PACS is a 510(k) summary, which for this particular device, focuses on substantial equivalence to a predicate device rather than a detailed clinical effectiveness study with specific performance metrics and acceptance criteria for a novel AI algorithm. The device, described as a multi-modality radiology reading and reporting station supporting 3D registration and PET-CT image reading, is a software modification to an existing PACS system.

Therefore, many of the requested points regarding acceptance criteria, AI performance, ground truth, and extensive study details typically associated with AI-driven diagnostic devices are not explicitly present in this type of submission. The focus is on verifying that the modified software performs as safely and effectively as the predicate device (Mirada Solutions Ltd, Fusion 7D).

Here's an attempt to extract the information based on the provided text, noting where information is absent:

Acceptance Criteria and Study Overview for Carestream PACS (K083673)

Summary:
The Carestream PACS device (K083673) is a modified PACS software, not a novel AI diagnostic algorithm. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Mirada Solutions Ltd, Fusion 7D) through performance testing under simulated use conditions. Explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) are not defined for the software's functionalities as a primary endpoint in this document. Instead, the acceptance criterion revolved around meeting design input requirements and conforming to user needs, demonstrating comparable safety and effectiveness to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Meet design input requirements and conform to defined user needs and intended uses.	"Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device."
Demonstrate comparable safety and effectiveness to the predicate device (Mirada Fusion 7D).	The modifications to the Carestream PACS, specifically software changes supporting 3D registration and PET-CT image reading, "do not alter the fundamental scientific technology" and "raise no new issues of safety or effectiveness." This implies that the new functionalities performed comparably to, or within the expected range of, the predicate device's capabilities for similar functions (though direct quantitative metrics are not provided in this summary). The new functionality's support for rigid space transformation, auto/manual registration, refinement, and "treat studies as registered" were verified. PET-CT image manipulation and SUV presentation were also verified.

Acceptance Criteria (Implied)

Reported Device Performance

Meet design input requirements and conform to defined user needs and intended uses.

"Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device."

Demonstrate comparable safety and effectiveness to the predicate device (Mirada Fusion 7D).

The modifications to the Carestream PACS, specifically software changes supporting 3D registration and PET-CT image reading, "do not alter the fundamental scientific technology" and "raise no new issues of safety or effectiveness." This implies that the new functionalities performed comparably to, or within the expected range of, the predicate device's capabilities for similar functions (though direct quantitative metrics are not provided in this summary). The new functionality's support for rigid space transformation, auto/manual registration, refinement, and "treat studies as registered" were verified. PET-CT image manipulation and SUV presentation were also verified.

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

Sample Size: Not specified in the provided text. The document refers to "nonclinical testing was conducted under simulated use conditions," but provides no details on the number of cases or studies used for testing.
Data Provenance: Not specified. It's likely simulated or internal test data given the "simulated use conditions" and non-clinical nature of the testing mentioned.

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

This information is not provided in the summary. For this type of 510(k) for a PACS workstation modification, it's less likely that a formal expert-adjudicated ground truth dataset was created, as the focus is on software functionality and comparability rather than diagnostic accuracy of a new clinical claim. Technical experts and software testers would have been involved in verifying functionality.

4. Adjudication Method for the Test Set

Not applicable / Not specified. Given the nature of the device and testing, a formal adjudication method (like 2+1 or 3+1) for clinical performance metrics is not mentioned or implied. Testing likely involved verifying the correct output of the registration algorithms and display of PET-CT images against expected results, rather than interpreting a "positive" or "negative" clinical finding.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study comparing human readers with AI assistance versus without AI assistance was not done and is not mentioned. This submission pertains to a PACS software update, not an AI-driven interpretive algorithm designed to directly improve human reader performance or make clinical decisions.

6. If a Standalone (Algorithm Only) Performance Study was done

Partially applicable, but for functionality rather than diagnostic accuracy. The "Discussion of Testing" mentions "Performance testing was conducted to verify the design output met the design input requirements." This implies standalone testing of the software functionalities (3D registration, PET-CT display and SUV calculation) to ensure they worked as intended. However, this is distinct from a standalone diagnostic performance study (e.g., measuring sensitivity/specificity of an AI model). The summary points to the algorithm's ability to perform rigid space transformations, automatically register datasets, allow manual registration and refinement, and calculate SUV values, which were verified functionalities.

7. The Type of Ground Truth Used

Internal specifications and engineering verification. For the functionalities described (3D registration, PET-CT display, SUV calculation), the "ground truth" would likely be defined by the technical specifications for these features. For example, for 3D registration, "ground truth" would involve known transformations or successful alignment verified by technical means. For SUV calculation, it would be the correct application of the defined formula and display. It is not expert consensus, pathology, or outcomes data related to disease diagnosis.

8. The Sample Size for the Training Set

Not applicable / Not specified. This device is a PACS system with image manipulation tools, not a machine learning model that requires a "training set" in the conventional sense of AI development for diagnostic tasks. The algorithms (e.g., for rigid registration) are likely rule-based or optimized through engineering, not trained on large clinical datasets in a machine learning paradigm.

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

Not applicable. As a training set for an AI model is not indicated, the method for establishing ground truth for such a set is irrelevant in this context.

Summary

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

K083673

Carestream PACS

Traditional 510(k): Carestream Health, Inc.

"510(k) Summary"

	DEC 30 2008
510(k) Owner Name:	Carestream Health, Inc.
510(k) Owner Address:	150 Verona StreetRochester, New York 14608
510(k) Owner Phone:	585 627-6543
510(k) Owner Fax:	585 454-1894
Contact Name & Info:	Linda StewartRegulatory Affairs Director, Medical Imaginglinda.stewart@carestreamhealth.com972-517-1481
Date Summary Prepared:	November 26, 2008
Device Trade Name:	Carestream PACS
Device Common Name:	PACS
Classification Name:	System, Image Processing, Radiological
Regulation Name:	Picture Archiving and Communication System
Device Class:	Class II
Device Code:	LLZ
Regulation Number:	21 CFR 892.2050
Predicate Device:	Mirada Solutions Ltd, Fusion 7DManufactured by Siemens Medical Solutions, Inc510(k) No. - K020546 (April 26, 2002)

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

Device Description:

The registration in the "Volume Matching" application can be created by these methods:

. Register Studies

Manually Register Studies .
The user is able to "manually" register two datasets by providing additional inputs to the registration algorithm. The matching of the two volumes is done based on the planes of the two studies and on the position of the two clicking points. This input should be enough to match the two dataset. The user should try to click on the same anatomical location in both studies. while both planes are already swiveled to represent the same anatomical plane.
. Refine Registration
The user is able to adjust the registration. The refine algorithm is actually a local registration algorithm that tries to match two volumes based on local, rather than global, similarity. Practically, it can serve the user when he/she wants to focus on a certain region and to compare it in the two datasets. In such cases, local registration is preferable, even if it means that the global registration will be of a poorer quality.
Treat Studies as Registered .
The application supports the "treat studies as registered" feature - the ability for the user to select datasets / all datasets for which the system should treat as if they are fully registered to one another. This is needed to support places where although the data doesn't have the same frame of reference, they were registered in a "black-box" and only then copied to the PACS. The algorithm is ignoring the exact clicking point.

The standardized uptake value (SUV) is a scmi-quantitative value that allows expression of FDG untake in a lesion relative to the injected dose. The

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

standardized uptake value (SUV) is defined as the ratio of activity in tissue per millimeter to the activity in the injected dose per patient body weight.

Intended Use:

Comparison of Technological Characteristics:

The modifications to the CARESTREAM PACS do not alter the fundamental scientific technology of the device. The only device modification was to the software. No new image manipulation tools are implemented that do not exist in the Fusion7D device. The device modifications raise no new issues of safety or effectiveness.

Discussion of Testing

Performance testing was conducted to verify the design output met the design input requircments and to validate the device conformed to the defined user needs and intended uses. Nonclinical testing was conducted under simulated use conditions. Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized eagle with three stripes extending from its back, representing health, human services, and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2008

Ms. Linda Stewart Regulatory Affairs Director, Medical Imaging Carestream Health, Inc. 150 Verona Street ROCHESTER NY 14608

Re: K083673

Trade/Device Name: Carestream PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 9, 2008 Received: December 11, 2008

Dear Ms. Stewart:

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 (PMA), 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.

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

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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

hope M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Statement of Intended Use

510(k) Number (if known):

Device Name:

Indications for Use:

083673

CARESTREAM PACS

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C.S.R. Pohank (acting)

Division Sign-Off Division of Reproductive, Abdominal. and Radiological Devi

TITLE: Statement of Intended Use Carestream PACS 11510(k) Number PART #: 8G7623 VERSION # 1.0

Unrestricted Internal Use (U) 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).