The intended use of the KinetDx, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

Device Description

KinetDx is a picture archival and communications system (PACS) that includes a dedicated DICOM server used for image and data storage, retrieval, and archiving. The server accepts images and data from DICOM acquisition devices attached to it by way of a network. The system also includes one or more workstations networked with the server, which are used for clinical review of images and data. Workstations also allow editing of patient demographic and clinical data, image manipulation, and preparation of clinician's reports.

AI/ML Overview

The provided text is a 510(k) summary for the KinetDx Medical Image Management Device, a PACS system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found in clinical validation studies.

PACS systems function as image management devices rather than diagnostic algorithms that produce specific findings requiring clinical performance metrics. Their "performance" is generally related to their ability to correctly store, retrieve, display, and process images, and their interoperability with other medical devices.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this particular 510(k) summary.

Here's an assessment based on the available information:

A table of acceptance criteria and the reported device performance:
- Not provided. This type of 510(k) summary for a PACS device typically focuses on substantial equivalence to predicate devices, and the functional characteristics rather than performance metrics against specific clinical acceptance criteria.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. No specific test set for evaluating diagnostic performance is mentioned. The device's "performance" would likely be assessed through engineering verification and validation (e.g., image integrity, speed of retrieval, display accuracy), which are not detailed here.
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. As no clinical performance study involving diagnostic accuracy is described, there's no mention of experts establishing ground truth for such a study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical performance study is described.
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 applicable. This device (KinetDx) is a PACS system for image management, not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. KinetDx is an image management system, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical performance study requiring ground truth is described.
The sample size for the training set:
- Not applicable. KinetDx is a PACS system; it does not explicitly use a "training set" in the machine learning sense to develop its core functionality. Its software is developed and tested through traditional software engineering processes.
How the ground truth for the training set was established:
- Not applicable.

Summary based on available information:

The KinetDx is a Picture Archival and Communications System (PACS). Its 510(k) submission focuses on demonstrating substantial equivalence to predicate PACS devices (EchoLink, ALI UltraPacs, ALI DataComPacs Module) based on technological characteristics (standard computer hardware, proprietary software, Windows 2000 OS, optional DAP card for faster decompression/display) and intended use (acceptance, transfer, display, storage, digital processing, manipulation, and quantification of diagnostic ultrasound, CT, MRI, and X-ray angiography images).

The document does not contain details of specific performance criteria or a clinical study to prove diagnostic accuracy, as this is not the primary function of a PACS system. Its "performance" would be related to its engineering validation and verification, ensuring it reliably manages and displays images as intended and substantially equivalent to predicate devices.

Summary

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

K023772

510(k) Summary of Safety and Effectiveness

Acuson Corporation's KinetDx - Medical Image Management Device

Acuson Corporation has not disclosed its intent to market this device modification and requests this notification be held CONFIDENTIAL by FDA, and not be released to any Freedom of Information request or addressed with any outside parties.

Sponsor:	Siemens Medical Solutions,Acuson Ultrasound Division1230 Shorebird WayMountain View, CA 94043
Contact Person:	Bob LeikerSenior Regulatory Affairs SpecialistTelephone: (650) 694-5080Fax: (650) 961-6168

Submission Date: October 31, 2002

Device Name: KinetDx

Common or Usual Name: Picture Archival and Communications System

Classification:

Picture Archival and Communications System (LLZ) class II (21CFR §892.2050)

Predicate Device:

EchoLink, K980060 cleared on February 25, 1998 ALI UltraPacs, K925965 cleared on June 14, 1993 ALI DataComPacs Module, K963610, cleared on November 27, 1996

Device Description:

Intended Use:

The intended use of the KinetD, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

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

Technological Characteristics and Substantial Equivalence:

Similar to the predicate devices, the computer hardware components used for the KinetDx server and review stations are standard computer hardware procured from qualified vendors, with the exception of an optional proprietary card available for review stations. This optional card, the KinetDx Dynamic Array Processor (DAP) card, provides faster decompression and display of image data than can be provided using regular system memory. The KinetDx server and review stations use proprietary software to accomplish their functions. Servers and review stations use the Windows2000 operating system.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Rockville MD 208

2.2. 2007

Acuson Corporation % Mr. Mark Job : 510(K) Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K023772

Trade/Device Name: KinetDx Picture Archiving and Communications System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: November 8, 2002 Received: November 12, 2002

Dear Mr. Job:

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 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 (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.

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

Page 2

This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-459
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-461
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-461
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-465
Other	(301) 594-469

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html.

Sincerely yours,

Henry 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}------------------------------------------------

KUL 3772

Incintended use of the KinetDy Indications For Use
The intended use of the KinetDy, is for the acceptance, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Legum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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).