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The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

The OEC® 9900 Elite Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Workstation is a mobile platform that supports image display monitors, image processing and recording devices. Interfaces are provided for optional peripheral devices such as thermal or instant film printers.

Since the input pertains to a medical device's 510(k) summary, specific acceptance criteria and detailed study results like sample sizes, ground truth establishment, and MRMC studies are typically not explicitly detailed in the summary itself. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial report.

However, I can extract the information that is present and indicate where details are not provided in this specific document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary for the OEC® 9900 Elite Mobile Fluoroscopy System does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen in a clinical study report. Instead, the demonstration of substantial equivalence is based on a comparison of features to a predicate device and an assessment of non-clinical performance data.

The conclusion states: "Performance testing included within this 510(k) demonstrates that the OEC® 9900 Elite is safe, effective and performs in an equivalent manner to the predicate device, with improved reliability and in accordance with its labeling."

Without specific numerical criteria or performance results in this document, a table cannot be accurately constructed. The "performance" here refers to the device meeting the essential safety and effectiveness requirements by being equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The summary mentions "non-clinical performance data" without specifying the nature or origin of the test sets used. Given it's a fluoroscopy system, testing would likely involve technical performance characteristics rather than patient data in the context of substantial equivalence to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the 510(k) summary. As noted above, the testing appears to be non-clinical performance data for the device itself, rather than diagnostic interpretation requiring expert ground truth establishment for a test set of images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary. Given the non-clinical nature of the described performance testing, an adjudication method for a test set (which typically refers to human interpretation of images) would not be applicable here.

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

An MRMC study was not conducted (or at least not mentioned) in this context. The OEC® 9900 Elite Mobile Fluoroscopy System is an imaging device, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. The 510(k) is for the imaging system itself.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a mobile fluoroscopic imaging system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given that the device is a fluoroscopic imaging system and the testing reported is "non-clinical performance data" for demonstrating substantial equivalence, the "ground truth" would likely relate to objective measurements of the system's technical specifications and imaging capabilities (e.g., image resolution, dose, contrast, noise, geometric accuracy) against established industry standards or the predicate device's performance, rather than clinical ground truth like pathology or outcomes data. However, the specific type of "ground truth" used is not detailed in the summary.

8. The sample size for the training set

This is not applicable as the device is a hardware imaging system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is a hardware imaging system, not a machine learning model.

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