Search Results

Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient.

Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

This is a Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. It can be used to upgrade film-based systems. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the E-COM DR-2000 DR software:
a. Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images.
b. Edit existing patient information.
c. Emergency registration and edit Emergency settings.
d. Pick from a selection of procedures, which defines the series of images to be taken.
e. Adjust technique settings before capturing the X-ray image.
f. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
g. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
h. Close a procedure when all images have been captured.
i. Review History images, resend and reprint images.
j. Re-exam a completed patient.
k. Protect patient records from being deleted by the system.
l. Delete an examined Study with all images being captured.
m. Edit user accounts.
n. Check statistical information.
o. Image QC.
p. Image stitching.

This document describes the FDA 510(k) premarket notification for the E-COM DR-2000 DR, a stationary x-ray system. However, it does not provide details regarding specific acceptance criteria, a study proving the device meets those criteria, or information on AI/standalone performance, expert adjudication, or ground truth establishment typically associated with such studies.

Here's a breakdown of the requested information based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. No specific test set for performance evaluation is mentioned. The submission states "Clinical Testing: Not required for a showing of substantial equivalence," implying a lack of a dedicated clinical test set for new performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Since no clinical testing or performance study is detailed, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. As no test set is described, no adjudication method is mentioned.

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 information is not provided in the document. The device is a "Stationary X-ray System" with software for image acquisition and management. There is no indication that it includes AI for interpreting images or assisting human readers. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided in the document. As there is no mention of an algorithm for image interpretation or analysis, a standalone performance study is not applicable and not mentioned. The device's software functions are primarily for image acquisition, processing, and management.

7. The Type of Ground Truth Used

This information is not provided in the document. Since no clinical performance study is described, there's no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

This information is not provided in the document. The submission pertains to a conventional x-ray system and its control software. There is no discussion of machine learning or AI components that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. As no training set is discussed (see point 8), the establishment of its ground truth is also not mentioned.

Summary of the Document's Content Regarding Testing:

The K193644 submission's primary focus is on demonstrating substantial equivalence to a predicate device (K130883, Sedecal Digital Radiographic Upgrade Model SDRU-T). This is achieved by comparing the new device's indications for use and technological characteristics to the predicate.

The document states:

• "Bench/Performance Testing: The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device."
• "Clinical Testing: Not required for a showing of substantial equivalence."

This indicates that the FDA clearance for E-COM DR-2000 DR was based on demonstrating similar technical specifications and safety/effectiveness profiles to an already cleared device, along with adherence to relevant software development and risk management guidance documents. It does not involve a new performance study with specific quantitative acceptance criteria or extensive clinical data as would be required for a novel device or one incorporating advanced AI algorithms.

Ask a specific question about this device