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The Web Clinical System is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.

The Web-Clinical System (WCS) is a component of the RAYPAX System, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The WCS is a system for managing radiological images and data by retrieving and browsing medical images through the World Wide Web, (Internet), a clients Intranet or over computer networks.

This document is a 510(k) summary for the 삼성 SDS Co. Ltd. RAYPAX™ Web Clinical System (WCS). It establishes substantial equivalence to a predicate device for marketing approval. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document describes the device's intended use and technological characteristics but does not define specific performance metrics or acceptance criteria for those metrics.
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin (country, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no test set described, there's no mention of experts or ground truth establishment.
4. Adjudication method for the test set: No test set means no adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a system for managing and displaying images, not an AI or diagnostic aid that would typically undergo MRMC studies with human readers for improved performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device description emphasizes human interpretation ("A physician, providing ample opportunity for competent human interprets images and information being printed."), indicating it's not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
8. The sample size for the training set: No training set is mentioned as this is not an AI/ML device that requires training.
9. How the ground truth for the training set was established: Not applicable without a training set.

Summary of available information related to device evaluation:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SECTRA IMTEC AB Wise II Image Management System) based on indications for use and technological characteristics. It mentions:

• Hazard Analysis: All potential hazards have been classified as "Minor."
• The system has been designed and will be manufactured in accordance with voluntary standards.
• The FDA's letter (K992426) confirms the device's substantial equivalence to legally marketed predicate devices.

This 510(k) process for this type of device (a digital imaging workstation/image communication accessory) in 1999 typically would not involve the kind of clinical performance studies and AI-specific metrics you've asked for. It's a system to manage and display images, meaning its efficacy is largely tied to its functionality, reliability, and security, rather than diagnostic accuracy as a standalone AI model.

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The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.

The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

The Display Workstation is one of the components of the RAYPAX, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The Display Workstation provides image-processing functions and workflow for the radiology department for medical images that are acquired and stored in the RAYPAX image server in DICOM 3.0 format.

Furthermore, the Display Workstation can transfer medical images stored in RAYPAX system to other PACS through a DICOM compatible network and can export images to other applications in bitmap format.

This 510(k) submission (K992306) describes the Samsung RAYPAX™ Display Workstation System. However, it does not contain a study or data proving the device meets specific acceptance criteria in the manner you've requested for a modern AI/CADe device.

This submission is from 1999 for a "Digital Imaging Workstation" which is essentially a specialized computer for viewing medical images. It predates the widespread use of AI/Machine Learning in medical devices and the rigorous performance testing and reporting requirements we see today for such algorithms.

Here's a breakdown based on the information provided, highlighting why most of your requested points cannot be answered from this document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not applicable / Not specified. This type of device (a display workstation) does not typically undergo performance testing with a "test set" of medical images in the way an AI algorithm would. Its function is to display images, not to autonomously interpret them or produce diagnostic outputs.
• The document mentions receiving digital images from various sources (CT, MR, Ultrasound, etc.), but this refers to its functionality, not a test dataset for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not specified. No ground truth establishment is mentioned because no performance study is detailed.

4. Adjudication method for the test set

• Not applicable / Not specified. No test set performance study is detailed.

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, an MRMC comparative effectiveness study was not done. This device is a display workstation, not an AI-powered diagnostic tool intended to assist human readers diagnostically.

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

• No, a standalone performance study was not done. The device's purpose is to display images for human interpretation, not to provide standalone diagnostic outputs. The document explicitly states: "A physician, providing ample opportunity for competent human intervention interprets images and information being printed."

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

• Not applicable / Not specified. No performance study with ground truth is mentioned.

8. The sample size for the training set

• Not applicable / Not specified. This device is not an AI algorithm that requires a training set.

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

• Not applicable / Not specified. No training set or ground truth establishment for a training set is mentioned.

Summary of the Study (as described in the 510(k) submission):

The "study" or justification for this device's acceptance is based on demonstrating substantial equivalence to a predicate device (Olicon Imaging Systems, Inc 02-Workstation & PACS View Software, K973959). The submission outlines:

• Device Description: What the device is and what it does (receives, stores, communicates, processes, and displays medical images in DICOM format).
• Indications for Use: The specific medical purposes for which the device is intended.
• Technological Characteristics: How it operates, noting it does not contact the patient, control life-sustaining devices, and that a physician interprets the images.
• Conclusion: The claim that the device is substantially equivalent to the predicate device, implying similar safety and effectiveness based on its technical features and intended use. The submission also mentions compliance with voluntary standards and a hazard analysis classifying potential hazards as "Minor."

In essence, this 510(k) application demonstrates that the Samsung RAYPAX™ Display Workstation performs the same functions, has similar technological characteristics, and is therefore as safe and effective as a previously cleared workstation. It does not involve the type of clinical performance study with specific acceptance criteria typically associated with AI/CADe devices.

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The Samsung RAYPAX™ Archive will be used to store & retrieve digital medical images and information about the images. The typical users are trained medical professionals.

The Samsung LTA can be part of RAYPAX PACS or can be a separate device for other manufacturer's PACS. It is used to store & retrieve digital medical images and information about the images using the DICOM 3.0 communication standard. RAYPAX LTA differs from some other PACS systems by having an additional storage unit management for medical images. The RAYPAX database stores and manages examination and patient information while the RAYPAX storage devices store and manage the medical images. To gather medical image data, RAYPAX uses DICOM 3. Using DICOM 3.0, medical-image producing equipment requests to store medical-image data in the DICOM gateway, which acts as the gateway to the Short Term Storage (STS). The DICOM gateway, after receiving such a request, stores the medical images in the STS. All the medical images that come into the STS are stored in the Long Term Archive. If there are images that need to be highly accessible, the LTA Manager transfers it to the STS. The RAYPAX system administrator sets this transferring authority.

The provided text describes a 510(k) Pre-Market Notification for the Samsung RAYPAX™ Long Term Archive (LTA) System, an archiving system for digital medical images. It focuses on regulatory submission and substantial equivalence to a predicate device, rather than performance studies of an AI-powered diagnostic device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

The document states:
"The 510(k) Pre-Market Notification for the LTA device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device."
And also, "The LTA device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being printed."

This indicates that the focus of this 510(k) submission is on the safety and effectiveness of the archiving system itself, and its substantial equivalence to an existing predicate device (Olicon Imaging Systems Archive K973463), rather than on the diagnostic performance of an AI algorithm interpreting medical images.

No information is available in the provided text to populate the requested table and details.

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The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert medical images and data into digital signals. The digital data can be stored, communicated. processed and displayed within the system and or across computer networks at distributed locations.

Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

The Samsung Film Digitizer (FD) can be part of the RAYPAX PACS (Picture Archiving and Communication System), or can be a separate device for other manufacturer's PACS. It converts analog films to digitized images in the DICOM (Digital Imaging and Communications in Medicine) Standard 3 compatible files. In addition, FD supports a patient information search, an image information management, digitization, a DICOM file generation, a simple image processing, and DICOM file transferring to other components of the PACS.

This document is a 510(k) summary for the Samsung RAYPAX™ Film Digitizer System. It describes the device's purpose, comparison to a predicate device, and confirms substantial equivalence to legally marketed devices. However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study details
• Standalone performance study details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document focuses on regulatory compliance and the device's technical characteristics and indications for use, not on a detailed analysis of its performance or the studies conducted to prove its efficacy against specific acceptance criteria.

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The Samsung RAYPAX™ is a device that receives digital images and data from various sources (including but not limited to 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.

The Samsung RAYPAX™ system handles various objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.

The provided text does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary for the Samsung RAYPAX™ System, which is a Digital Imaging System (PACS). It primarily focuses on demonstrating substantial equivalence to a predicate device.

The information requested in the prompt (acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in the provided text. The document states that the system "has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey" and that "The submission contains the results of a hazard analysis. All potential hazards have been classified as Minor." However, these are general statements about manufacturing and risk assessment, not specific performance criteria or a detailed study.

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