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The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems.

The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures.

The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

The O-arm® Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-arm® Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitor).

The provided document is a 510(k) summary for the Medtronic O-arm® Imaging System. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria.

The document states: "Based on design characteristics and imaging performance, the modified O-arm® Imaging System is substantially equivalent to the predicate Oarm® Imaging." This suggests that the device was deemed substantially equivalent to a predicate, rather than being subjected to a specific performance study with acceptance criteria.

Therefore, most of the information requested in your prompt cannot be extracted from this document, as it focuses on substantial equivalence rather than a detailed performance study against acceptance criteria.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It relies on a qualitative comparison to a predicate device, stating "Same as predicate O-arm® with image quality improvement."

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

• Cannot be provided. No test set or study data is described.

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):

• Cannot be provided. No ground truth establishment related to a specific study is mentioned.

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

• Cannot be provided. No test set or adjudication method is described.

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:

• Cannot be provided. This document is for an imaging system (hardware), not an AI-assisted diagnostic device. No MRMC study is mentioned.

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

• Cannot be provided. This document is for an imaging system (hardware), not an algorithm.

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

• Cannot be provided. No specific ground truth for performance evaluation is mentioned.

8. The sample size for the training set:

• Cannot be provided. No training set is mentioned as this is an imaging system, not an AI algorithm.

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

• Cannot be provided. No training set is mentioned.

Summary based on the provided text:

The submission focuses on demonstrating substantial equivalence to existing predicate O-arm® Imaging Systems. The primary method of "proving" its acceptability is through this comparison, noting that the "modified O-arm® Imaging System is substantially equivalent to the predicate Oarm® Imaging" based on "design characteristics and imaging performance." There is no detailed performance study with specific acceptance criteria outlined in this document.

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