(149 days)
ExamVue Duo is a software for the acquisition, processing, storage and viewing of digital radiology studies. ExamVue Duo is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue Duo is indicated for use in general imaging including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
ExamVue Duo is not indicated for use in mammography.
The ExamVue Duo software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors and (optionally) generators and manufacturer supplied software for the acquisition and storage of digital x-ray studies. The ExamVue Duo software then provides a user interface for the viewing, annotating, and other workstation functions.
Exam Vue DR includes the ability to receive patient information and send studies to remote destinations using the DICOM 3.0 protocol.
I apologize, but the provided text from the FDA 510(k) Premarket Notification for the ExamVue Duo device does not include the specific details of a clinical study or performance data that would enable me to fulfill your request.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (ExamVue DR) rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria.
Here's why I cannot provide the requested information based on the given text:
- No Acceptance Criteria Table or Reported Performance: The document lists characteristics for comparison between the proposed device (ExamVue Duo) and the predicate (ExamVue DR), but it doesn't define quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or other performance metrics. It primarily states "SAME" or lists technical specifications (e.g., RAM, Processor) rather than clinical performance data.
- Absence of a Clinical Study Description: The document states "Bench tests reports and clinical data have been provided, detailing the direct comparison of functions between the ExamVue Duo and predicate device" (Page 4). However, the actual reports or detailed methodology of such "clinical data" are not included in this 510(k) summary. It vaguely refers to "direct comparison of functions," which likely means comparing the implementation of features rather than a clinical outcome study.
- No mention of AI/Algorithm-Specific Performance: The document describes ExamVue Duo as "software for the acquisition, processing, storage and viewing of digital radiology studies." While it mentions "image processing," there is no indication that the device includes an AI/ML algorithm that would necessitate specific performance metrics like those typically associated with AI-driven diagnostic aids (e.g., AUC, sensitivity, specificity for disease detection). The "added functions" like "Auto Stitching" and "Bone Suppression (option)" appear to be standard image processing features, not necessarily AI.
- No Details on Ground Truth Establishment, Experts, Adjudication, or MRMC Studies: Since no clinical study evaluating specific performance metrics is described in the provided text, there are no details about sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or how ground truth was established for a test set.
In summary, the provided document is a 510(k) submission showing substantial equivalence, not a detailed clinical study report. It compares the technical specifications and general functions of the new device to a previously cleared one. Therefore, I cannot extract the specific information you are looking for regarding acceptance criteria and a study proving those criteria are met for an AI/CAD/similar 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.