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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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