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The EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured Radiographic & Fluoroscopic ("R/F") systems. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review, providing assistance to Radiologic Technologists in routine diagnostic examinations and special procedures in R/F. The EPS system may be used to acquire, display, record, archive, and disseminate digital R/F image data.

The Electronic PhotoSpot (EPS) is a 10 bit PC based multitasking acquisition/display system configured for use in R/F applications. This system is designed for use by a qualified Radiologic Technologist. More specifically, the EPS system is a digital recording system designed for use as an electronic photospot device on OEM manufactured R/F systems. This system consists of independent and simultaneous acquisition of data, review, post processing of raw data and archive transfer functions. The system is modular in configuration allowing single and dual room configurations for acquisition and/or review. The system has 10 bit, 1024 digital acquisition, display and storage capability and uses a Windows based operator interface on the Operator Console/Review Station. It includes the following major components (minimally): Pentium computers, Image monitor(s), Camera X-Ray Interface, MOD media for archival, Software program developed by Marquette Medical Systems to run in conjunction with Microsoft Windows NT. The EPS provides image acquisition, display, archival, and exchange media compliant with the DICOM 3.0 standard. Furthermore, the EPS allows connection to the medical facility's existing LAN network for data dissemination to support reviews, reports, and patient billing.

The provided text is a 510(k) summary for the Marquette Medical Systems' EPS (Electronic PhotoSpot) system. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain details about acceptance criteria, a specific study proving device performance, or the various aspects of a clinical study typically associated with new device validation.

The document focuses on establishing equivalence rather than presenting novel performance data. Therefore, I cannot extract the requested information from the provided text.

Here's why the information you requested is not present:

• Acceptance Criteria and Reported Device Performance: The document describes the system's capabilities (e.g., 10-bit, 1024 digital acquisition, display, and storage) and features (acquisition, display, archival, DICOM 3.0 compliance) but does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) against predefined acceptance criteria. The purpose of a 510(k) is often to show that a new device is "as safe and effective" as a predicate, rather than to prove new performance claims with a dedicated study against hard targets.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document does not describe any specific study conducted to validate the device's performance. There is no mention of a test set, training set, expert radiologists establishing ground truth, or any form of multi-reader, multi-case study. The FDA clearance is based on comparison to a predicate device, not on a new clinical performance study. The "Predicate Device" section confirms this, stating, "A comparison of device specifications and principles of operation indicates no new questions of safety or efficacy, or substantial risk are raised."

In summary, the provided 510(k) document is for a medical imaging system that handles acquisition, display, and archiving, and it establishes substantial equivalence to a predicate device. It does not contain the kind of clinical study data, acceptance criteria, or performance results that would typically be found in a submission for a device making novel diagnostic claims or requiring new clinical validation.

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