(14 days)
The Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trolley).
The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
The Essenta DR is a multifunctional system, in which a swivel arm holds the x-ray tube and the x-raydetector. The generator, x-ray tube housing assembly, beam limiting device, deector, including the workstation for image processing and the optional mobile x-ay table (trolley) are known components. The geometry of the Essenta DR contains a central column, on which the height-adjustable and rotatable swivel arm is mounted. The rotatable detector and the rotatable x-ray tube with control section are mounted at the swivel arm. This enables the radiation beam to be adjusted to any position on a vertical plane. A second control section on the detector carrier allows positioning on the patient to be carried out at the detector itself. The vertical adjustment of the swivel arm, the rotation of the swivel arm and the SID adjustment are motorized. It esables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the auto-positioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.
This document is a 510(k) summary for the Essenta DR, a digital multifunctional X-ray system. It outlines the device's description, intended use, and comparison to a predicate device.
Here's an analysis of the provided text in relation to your questions:
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Table of acceptance criteria and the reported device performance, Sample size used for the test set and the data provenance, Number of experts used to establish the ground truth for the test set and the qualifications of those experts, Adjudication method, Multi reader multi case (MRMC) comparative effectiveness study, Standalone (i.e. algorithm only without human-in-the-loop performance), Type of ground truth used, Sample size for the training set, How the ground truth for the training set was established:
The provided text is a 510(k) summary for a medical device (Essenta DR X-ray system) seeking substantial equivalence to a predicate device (PHILIPS BUCKY VISION). This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as might be seen for novel AI/CAD systems.
Therefore, the document does not contain any of the requested information regarding acceptance criteria, device performance metrics, sample sizes for test or training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The 510(k) summary explicitly states: "The Essenta DR does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Essenta DR to be substantially equivalent with the predicate device." This indicates a focus on equivalence rather than detailed performance reporting from new clinical trials.
In summary, none of the specific information requested in your numbered points can be extracted from the provided text. The document serves as a regulatory filing for an X-ray system, not a scientific study report detailing performance metrics against acceptance criteria for an AI/CAD diagnostic device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.