PACSPartner™ is software that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing. 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 FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.

Device Description

PACSPartner™ makes possible the capturing, storage, viewing, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.

AI/ML Overview

This PACSPartner™ 510(k) summary (K042311) describes a Picture Archiving Communications System (PACS). As a PACS system, its primary function is to capture, store, view, distribute, and network medical images. The provided document does not contain information about acceptance criteria or a specific study proving the device meets performance criteria in the way one would expect for an AI/CADe device.

Here's why and what information can be inferred:

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

This information is not available in the provided 510(k) summary. For a PACS system, performance criteria typically relate to:

Image Fidelity: Ensuring images are displayed accurately without loss of diagnostic information.
Data Integrity: Reliable storage and retrieval of image data.
Speed/Throughput: Timely transmission and display of images.
Interoperability: Compatibility with various imaging modalities and DICOM standards.
Security: Protection of patient data.

The 510(k) process for a PACS system like PACSPartner™ primarily focuses on demonstrating substantial equivalence to a predicate device (PACSPlus™ K023460) based on technological characteristics and indications for use, rather than a specific performance study with pre-defined statistical acceptance criteria like sensitivity/specificity for a diagnostic algorithm.

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

This information is not applicable/not provided as there is no specific performance study testing image interpretation accuracy or diagnostic capabilities of the device in a clinical context described. The device itself is a system for managing images, not for interpreting them.

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):

This information is not applicable/not provided for the same reasons as above. Ground truth establishment is typically relevant for evaluating diagnostic or interpretive AI/CADe systems.

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

This information is not applicable/not provided.

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:

This information is not applicable/not provided. This device is not an AI/CADe system designed to assist human readers in interpretation. It's an infrastructure system for image management.

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

This information is not applicable/not provided. This device is not a standalone diagnostic algorithm. Physicians interpret images using the system, as stated: "A physician, providing ample opportunity for competent human interprets images and information being displayed and printed."

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

This information is not applicable/not provided.

8. The sample size for the training set:

This information is not applicable/not provided. The device is a software system, not a machine learning model that requires a training set.

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

This information is not applicable/not provided.

Summary of what the document does indicate about "meeting criteria":

The document demonstrates that PACSPartner™ meets the regulatory requirement for substantial equivalence to its predicate device, PACSPlus™ (K023460). This is the primary "acceptance criterion" for a 510(k) submission of this type. The study, in this case, is the comparison of technological characteristics and indications for use between PACSPartner™ and PACSPlus™.

The key statements supporting this are:

"The 510(k) Pre-Market Notification for PACSPartner™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device."
The FDA's letter states: "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... to legally marketed predicate devices..."

The "proof" is the FDA's decision letter confirming substantial equivalence, which is based on the comparison presented in the 510(k) summary, primarily focusing on:

Identical Indications for Use: Both devices manage and display digital medical images.
Similar Technological Characteristics: Both are software products that handle digital images, do not contact the patient, do not control life-sustaining devices, and rely on human interpretation.

Therefore, for this specific 510(k) submission, the "acceptance criteria" are regulatory conformance and demonstrated equivalence to a legally marketed predicate device, and the "study" is the comparison outlined in the 510(k) summary leading to the FDA's substantial equivalence determination.

Summary

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K04 2311

Image /page/0/Picture/1 description: The image shows the word "PACS" in large white letters on a black background. To the right of "PACS" is the website address "www.pacspartner.com" in a smaller font, also in white. The overall design is simple and clean, with a focus on the company name and its online presence.

SEP = 9 2004

510(k) Summary of Safety and Effectiveness

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

Date Prepared: August 2, 2004

Submitter's Information: 21 CFR 807.92(a)(1) YoungJin Hong Technical Manager Medical Standard Co. Ltd., Hanyang Institute of Technology 17, Haengdang-dong Sungdong-ku Seoul, Korea, 133-791

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) PACSPartner™ Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:

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

Device Classification Name	system, image processing, radiologica
510(k) Number	K023460
Regulation Number	892.2050 Class II
Device Name	PACSPlus™
Applicant	Medical Standard Co. Ltd.,
Product Code	LLZ
Decision Date	01/09/2003
Decision	Substantially equivalent (SE)
Classification Advisory Committee	Radiology
Review Advisory Committee	Radiology
Type	Traditional

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

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

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Image /page/1/Picture/0 description: The image shows the word "PACS" in white font on a black background. To the right of the word "PACS" is the website address "www.pacspartner.com", also in white font. The font appears to be slightly pixelated. The image is simple and contains only text.

and or across computer networks at distributed locations. Options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. 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 FDA Typical users of this system are trained professionals, physicians, nurses, and technicians.

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

PACSPartner™ is a software product that handles digital mages. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.

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

The 510(k) Pre-Market Notification for PACSPartner™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

PACSPartner™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Minor".

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2004

Medical Standard Co., Ltd. % Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave., SE GRAND RAPIDS MI 49548

Re: K042311

Trade/Device Name: PACSPartnerTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: August 24, 2004 Received: August 26, 2004

Dear Mr. Devine:

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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in you to organization of substantial equivalence of your device to a legally premarket noticate 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 desire specific advise at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Complianoo at (2017 oration" (21CFR Part 807.97) you may obtain. Other general of reference to promation in the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or Hanafabrer of Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancy C. Brogdor 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 Form)

K042311 510(k) Number:

Device Name:

PACSPartner™ software by Medical Standard Co. Ltd.

Indications for Use:

Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing.

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 FDA.

Typical users of this system are trained professionals, physicians, nurses, and technicians.

AD/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lepson

(Division Sign-Off) Division of Reproductive, Abo 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).