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This software displays medical images and associated documents. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the software is intended for use as a primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for use by trained healthcare professionals. Each healthcare professional must determine if the level of loss is acceptable for their purpose. This software is not suitable for primary diagnosis of mammograms.

RapidResults is a cutting edge application that provides of interactivity while maintaining the ease of use and security you've come to expect from RamSoft. Patient images and reports are available to view with zero footprint as there is no need to download special software. With RapidResults, the software allows users to perform image manipulations, including windowlevel, rotation, flip, zoom, panning, hanging protocol layout, measurement, localizer line, and study linking.

Available on popular mobile and desktop platforms with keyboard, mouse, and touch inputs, RapidResults provides access to medical images and associated documents in a convenient way for health care professionals to use as primary diagnostic and review tools.

RapidResults supports major desktop and mobile browsers such as Internet Explorer 10.0 or higher, Chrome, and Safari, Apple iOS, Android, Windows Mobile. It has been extensively tested with iOS (iPad Retina, iPad 2, and iPhone), Android (Galaxy Tab Pro, Galaxy Notes), Windows Mobile (Dell Latitude 10-ST2 Windows 8 Pro Tablet).

The provided text describes a 510(k) premarket notification for the device "RapidResults" by RamSoft, Inc. The document aims to demonstrate substantial equivalence to a predicate device, focusing on its intended use as a medical image display and review tool.

However, the provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology of such a study. The document primarily focuses on establishing substantial equivalence to a predicate device (Centricity Universal Viewer Zero Footprint client, K131977) by comparing general characteristics and intended uses.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies based solely on the provided text.

The closest information related to "performance" is a general description of the device's functionality and a comparison of features with the predicate device, but not quantitative performance against pre-defined acceptance criteria.

Key points from the document that are relevant to the requested categories (but lack the specific details you're looking for):

• Device Name: RapidResults
• Intended Use: Primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for medical images and associated documents. Not suitable for primary diagnosis of mammograms.
• Predicate Device: Centricity Universal Viewer Zero Footprint client (ZFP) - K131977
• Testing Mentioned: "It has been extensively tested with iOS (iPad Retina, iPad 2, and iPhone), Android (Galaxy Tab Pro, Galaxy Notes), Windows Mobile (Dell Latitude 10-ST2 Windows 8 Pro Tablet)." This refers to compatibility testing, not a clinical performance study.
• HIPAA Compliance: The viewer "secured connects to the PACS using HTTPS" and "Images stay in the PACS, not on the device."

To answer your request, I would need a different type of document, such as a detailed design validation report or a clinical study report, which would typically be submitted as part of the 510(k) submission but are not included in this summary.

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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.

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.

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:

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.

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RamSoft PACS software is used with general purpose computing hardware to acquire, transmit, store and display images for clinical purposes. RamSoft PACS consists of one or more of image server, web server, database server, and workstations for interpretation, clinical review, quality control, video capturing, film digitizing, document scanning. Images may be acquired from imaging devices such as CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.

RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication, and storage.

The provided text describes RamSoft PACS, a Picture Archiving and Communication System, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a clinical or technical study against acceptance criteria.

Here's a breakdown of why this information is missing, based on the provided text:

• Intended Use and Description: The document states the software's purpose (acquire, transmit, store, and display images) and that it is "tested according to the specifications that are documented in a RamSoft PACS System Test Plan." However, the details of these specifications (acceptance criteria) and the results of such testing are not included.
• Substantial Equivalence: The core of this 510(k) summary is the comparison table to predicate devices (RamSoft Ultrapro 98, Kodak AutoRad, GE Advantage). This table focuses on functional equivalency (e.g., "Print to paper: Yes," "Graphical UI: Yes," "Image input: DICOM 3.0"). This is a comparison of features, not a performance study.
• Conclusion: The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance tests." This directly indicates that the information you are requesting (a study proving device performance against acceptance criteria) was not part of this particular submission for FDA clearance.
• Level of Concern: The document mentions "failure or latent design flaw would not be expected to result in death or injury to a patient," classifying the "Level of Concern" as "minor." This relates to risk assessment, not device performance metrics.

Therefore, I cannot provide the requested information from the given text because it is not present. The document focuses on demonstrating substantial equivalence in features and intended use to already cleared devices, rather than presenting a performance study against acceptance criteria for the RamSoft PACS.

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Ultrapro is a system that utilizes standard personal computer hardware to acquire, display, communicate and archive diagnostic images. The system is designed for use by medical professionals to acquire data from FDA listed imaging equipment such as ultrasound, CT and MRJ scanners, x-ray imagers and video cassette recorders that provide a video output or a digital output. Archival is to be performed on media that is FDA listed.

Ultrapro can be configured to use JPEG lossy compression. When lossy compression is used, the compression ratio will be imprinted in the non-diagnostic area of the image. The compression ratio can be adjusted during acquisition.

Ultrapro is a tool for a medical imaging practice. It can acquire medical images from any standard medical video source. Digital data in the DICOM format or other popular PC formats such as JPEG, TIFF, etc. can also be acquired.

Images may be acquired in uncompressed or compressed format (lossless or lossy). The lossy compression ratio is selected by viewing the original image and the lossy compressed image side by side and increasing the ratio while retaining clinically significant characteristics. Images that have been lossy compressed have the text "LOSSY xx:1" where xx is the compression ratio placed in the visible, non-diagnostic area of the image.

Related patient information can also be entered or scanned in with a TWAIN compliant scanner. Once acquired, Ultrapro serves as a digital storage for these images. Images are stored on the computer. Images may be communicated to other Ultrapro workstations or to third-party DICOM 3.0 compliant PACS components. The radiologist may review the images with Ultrapro and create reports. The display of images (contrast, brightness, zoom, etc.) may be adjusted at any time. Annotations may be drawn on images. Distance measurements may be made on images. These image parameters may be saved along with the image while still preserving the original image. This information can be communicated to other workstations through a network or modem. Finally, all of the information may be archived onto optical media for permanent storage.

The provided text is a 510(k) Summary for the "Ultrapro 98" Picture Archiving and Communication System (PACS) from RamSoft Inc. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific studies proving device performance against those criteria. The document explicitly states:

"The determination of substantial equivalence is not based on an assessment of performance tests."

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from this document. The sections you asked about are not present in the provided text.

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