POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE by RAMSOFT, INC.

This software is used with general purpose computing hardware for the storage, review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from imaging devices such as CR, CT, DX, MR, MG, NM, PT, RF, US, XA, film digitizers, and document scanners, and other DICOM devices. With appropriate hardware, the software is intended for use as a primary diagnostic, analysis, and review tool for use by trained healthcare professionals.

It is the user's responsibility to ensure image quality, lighting, and image compression ratios are suitable for the clinical application.

Digitized film should not be used for primary diagnosis in mammography. Lossy compression should not be used for primary diagnosis in mammography. Primary diagnosis on digital mammograms should not be done on any monitors other than those specifically cleared by the FDA for digital mammography applications. Film printing for digital mammography should not be performed on any printers other than those specifically cleared by the FDA for digital mammography applications.

Device Description

The PowerServer software suite is used on general purpose computing hardware and includes the following components: PowerServer, PowerReader, Gateway, and PowerCache. As long as minimum hardware and operating system requirements are met, the user or system integrator is free to choose his/her own hardware platform.

PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer.

PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.

Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.

AI/ML Overview

The provided 510(k) summary for K052460 (RamSoft's PowerServer, PowerReader, Gateway, PowerCache) does not contain specific acceptance criteria or an explicit study proving performance metrics against such criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the device's functionality, and outlining the developmental testing measures taken. It does not include quantitative performance data, clinical study results, or benchmarks for accuracy, sensitivity, specificity, resolution, or other clinical metrics typically found in documents for AI/Dx devices.

Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.

Here's an explanation of why the information is not present in the provided text:

Device Type: This submission is for a Picture Archiving and Communication System (PACS) and associated components. These types of devices are primarily for image management, display, and workflow, not for automated diagnostic interpretation (like an AI algorithm for disease detection). Therefore, the regulatory requirements often focus on technical performance (e.g., DICOM compliance, image integrity, display capabilities, security, interoperability) rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
Regulatory Pathway: A 510(k) submission generally aims to demonstrate "substantial equivalence" to a legally marketed predicate device, meaning it performs as safely and effectively as the predicate. For PACS, this often involves validating that the displayed images meet certain quality standards for human interpretation, and that the system correctly stores and retrieves data. It does not typically require a standalone clinical efficacy study in the same way an AI diagnostic algorithm would.
Date: The submission date is 2005. The regulatory landscape and expectations for AI/ML devices, including detailed performance studies, have evolved significantly since then. In 2005, the concept of "AI" in medical devices as we understand it today was nascent, and most submissions for image processing or viewing systems would not include the level of detail requested in your prompt regarding AI-specific validation.

Information that can be extracted or inferred:

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

Acceptance Criteria (Inferred - for a PACS system)	Reported Device Performance (From "Test Summary")
Functional Safety and Design Integrity:	Hazard Analysis
Compliance with Requirements	Requirements Reviews
Design Adequacy	Design Reviews
Code Quality	Code Reviews
Software Quality and Performance:	Unit Testing
System Integration and Functionality	System Testing
Validation against Intended Use	Validation Testing
Overall Performance and Responsiveness	Performance Testing
Equivalence to Predicates:	"This device is as safe, as effective, and performs as well as predicate devices."
DICOM Compliance	"The system is DICOM compliant for image storage, archiving, retrieval, and transmission..."
Image Data Integrity	"Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state."

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

Not provided. The summary mentions various types of testing (Unit, System, Validation, Performance Testing) but does not detail the nature of these tests in terms of data sets, sample sizes, or data provenance.

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. As this is a PACS system, not an AI diagnostic algorithm, "ground truth" as it pertains to clinical accuracy or disease diagnosis is not typically established for the device itself in this context. The system's purpose is to display images for human experts (healthcare professionals) to establish ground truth or make diagnoses. The testing described focuses on software quality and functional performance.

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

Not applicable/Not provided. No adjudication method is mentioned, as the testing described is not clinical diagnostic performance testing.

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, not done. Such a study is not mentioned. AI assistance or diagnostic capabilities are not claimed or detailed for this PACS system. Its primary function is image management and display.

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

Not applicable/No. This device is explicitly described as a tool for use by trained healthcare professionals as a "primary diagnostic, analysis, and review tool." It is not a standalone diagnostic algorithm.

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

Not applicable/Not provided. For the reasons mentioned above, clinical "ground truth" for diagnostic accuracy is not relevant to the described testing for this PACS system.

8. The sample size for the training set:

Not applicable/Not provided. This device is a software suite for PACS, not a machine learning model that requires a "training set" in the context of AI. The software is developed based on requirements and tested for functionality, not "trained" on data to learn patterns.

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

Not applicable. As there is no AI training set, there is no ground truth established for it.

Summary

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K052460

510(k) Summary of Safety and Effectiveness

Date: September 13, 2005

Submitter: RamSoft Inc 16 Four Seasons Place, Suite 215 Toronto, ON M9B 6E5, CANADA

Contact Name: Vijay Ramanathan

Trade Names: PowerServer, PowerReader, Gateway, PowerCache

Common Name: Picture Archiving and Communication System (PACS)

Classification Name: LLZ - Image Processing System (892.2050)

Substantially Equivalent devices: RamSoft PACS (RamSoft Inc) - K031562 Centricity PACS System (GE Medical Systems Information Technologies) -K043415

Description:

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510(k) Summary of Safety and Effectiveness

Intended Use:

It is the user's responsibility to ensure image quality, lighting, and image compression ratios are suitable for the clinical application.

Technology:

This device employs the same functional scientific technology as its predicate devices.

Test Summary:

This device complies with the voluntary standards as detailed in Section A.8 of the 510(k) submission. The following testing measures were applied to the development of this device:

Hazard Analysis .
Requirements Reviews .
. Design Reviews
. Code Reviews
Unit Testing t
. System Testing
Validation Testing .
Performance Testing .

Conclusion:

This device is as safe, as effective, and performs as well as predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines resembling bird wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vijay Ramanathan President and CEO RamSoft, Inc. 16 Four Seasons Place, Suite 215 Toronto, ON, M9B 6E5 CANADA

SEP 2 1 2005

Re: K052460 Trade/Device Name: PowerServer, PowerReader, Gateway, and PowerCache Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 13, 2005 Received: September 14, 2005

Dear Mr. Ramanathan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your bettler by substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enerobate) to the enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, and chance 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 do not require upproval of a provisions of the Act. The general controls provisions of the Act device, subjoct to the generation, 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 n your do role is election (t to such additional controls. Existing major regulations affecting your Apployally, It they of below 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 I DA nas made a no 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 anow you to ocgin mancing your avice of your device of your device to a legally premarket notification. The PDA miding of sabstantial of a permits 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), pleased If you desire spectic advice for your device on our laboring 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 premated notification" (21 CFR Also, please note the regulation entitled, "rinsonalists of our responsibilities under the Act from the 180 807.97). You may obtain other general miornation on Jour September 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. 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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510(k) Number (if known): K052460

Device Names: PowerServer, PowerReader, Gateway, PowerCache

Indications for Use:

This software is used with general purpose computing hardware for the storage, review, This software is used with general purpose editing, and processing of digital images and analysis, annotation, distribution, printing, coming, conning, Can., MR, MG, NM, PT, RF, US,
data acquired from imaging devices such as CR, CT, DX, MR, MG, NM, PT, RF, US, data acquired from imaging devices such as CR, OT, OT, COM devices. With appropriate XA, film digitizers, and document scauncis, and other Drognostic, analysis, and review tool for use by trained healthcare professionals.

It is the user's responsibility to ensure image quality, lighting, and image compression in ratios are suitable for the clinical application.

Digitized film should not be used for primary diagnosis in mammography. Lossy Digitized inin should not be used for primary diagnosis in mammography. Primary compression should not be used for primary claghests in any more of economics on the than those diagnosis on digital mammograms should not be done on any more them them them them for specifically cleared by the I DA for digital mannogan printers other than those
digital mammography should not be performed on any printers other than those digital mammography should not of persons mammography applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
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-OR- Over-The-Counter Use ____________________________________________________________________________________________________________________________________________________

David h. Syam

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).