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The OEC 9800 E/CV+ Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. It includes features designed specifically for diagnostic and interventional cardiac imaging procedures, and is also intended for use in cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may also be used for other imaging applications at the physician's discretion.

The OEC 9800 E/CV+ is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus, which supports an x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various and distances with respect to the patient. The mobile workstation supports image display monitors, image processing and recording devices.

The provided text is a 510(k) summary for the GE OEC 9800 E/CV+ Digital Mobile Imaging System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a study with detailed performance metrics.

Therefore, the input document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

The document focuses on:

• Device Description: What the device is and its components.
• Indications for Use: The medical procedures for which the device is intended.
• Substantial Equivalence: A claim that the device is similar to previously cleared devices (GE OEC 9800 Plus Mobile Digital Imaging System and Siemens Medical Solutions Powermobil).
• Standards Compliance: A list of safety and electrical standards the device adheres to.

Conclusion based on the provided text:

1. Table of acceptance criteria and reported device performance: Not provided. The document states substantial equivalence to predicate devices, but no specific performance criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance study against acceptance criteria is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a fluoroscopic imaging system, not an AI-powered diagnostic tool for interpretation assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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