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510(k) Data Aggregation
(217 days)
For spinal administration of anesthetic agents to provide regional anesthesia.
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I am sorry, but the provided text ({0}, {1}, {2}, {3}) does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification response from the FDA regarding a spinal needle, confirming its substantial equivalence to a legally marketed predicate device. It briefly mentions the "Indication For Use" of the device, but there are no details about specific performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
Therefore, I cannot provide the requested table or answer the specific questions about a device study.
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