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The Ceiling Mounted Lateral Positioners Model 6896.002 will be used for cardiac imaging required for electrophysiology and heart catherizations imaging

Ceiling Mounted Lateral Positioner, Model No. 6896.002

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Ceiling Mounted Lateral Positioner, Model No. 6896.002." This letter confirms that the device has been found substantially equivalent to a predicate device.

This document does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective as the predicate. It typically relies on comparisons of design, materials, indications for use, and performance data from engineering tests, rather than extensive clinical studies with specified acceptance criteria and expert-adjudicated ground truth as would be found in a clinical trial report for an AI/ML medical device.

Therefore, I cannot provide the requested information based on the provided text.

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