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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Model OSC-085 Shoulder Array Coils

This document is a 510(k) clearance letter from the FDA for a medical device (Model OSC-085 Shoulder Array Coils). It primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does NOT contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.

The 510(k) process for this type of device (a coil for an MRI scanner) generally relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove performance against specific acceptance criteria. The "study" mentioned in the request typically refers to performance studies against specific endpoints, often seen for AI/ML devices or novel diagnostic tools. For a peripheral component like an MRI coil, the "study" is usually more focused on technical performance and safety compared to the predicate device.

Therefore, I cannot provide the requested information based on the provided text. The document is essentially a regulatory approval letter, not a performance study report.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report from the manufacturer.

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