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The intended use of the Echobright Kit is for regional anestheria and analgesia via blockade of peripheral nerves.

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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a device called "Echobright" and primarily focuses on the substantial equivalence determination.

It does not contain details about:

• Specific acceptance criteria for device performance.
• Any performance study results, including metrics like sensitivity, specificity, accuracy, or reported performance.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document only states the device's intended use and confirms its substantial equivalence to predicate devices, which implies that the regulatory requirements for safety and effectiveness were met, but it does not describe the specific testing or performance metrics used to demonstrate this.

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