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The Reach Needle is used for in injecting local anesthetics into a patient to provide regional anesthesia.

The Reach Needle is a sterile, single use, 4-inch-long needle used for administering anesthetic solutions for regional anesthesia. The Reach Needle is 27-qauge needle that is reinforced to reduce needle flex during administration of anesthesia solutions. The needle tip is a short bevel quincke style tip that extends approximately 2mm past the reinforcing shaft, providing a distal stop for consistent injection depth. The distal end of the needle has a slight bend to help access difficult to reach areas such as nasal anatomy. The needle hub is compatible with luer lock connectors. The Reach Needle is intended for use in adults (≥ 22 years).

The provided text is a U.S. FDA 510(k) summary for the "Reach Needle," an anesthesia conduction needle. It outlines the device's characteristics, intended use, and comparison to a predicate device.

Crucially, the document explicitly states under the section "Summary of clinical test": "Clinical testing was not necessary for this device."

This means that the device's acceptance was based on non-clinical testing (e.g., in vitro or bench testing) and a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical study involving human patients or complex AI algorithms requiring extensive ground truth establishment and expert adjudication.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as the nature of the device (a medical needle, not an AI or imaging device) and the regulatory pathway chosen (510(k) based on substantial equivalence and non-clinical data) did not involve such a study.

The questions you asked are highly relevant for AI/ML-enabled medical devices or devices where performance needs to be validated against complex human assessment or outcomes, but they do not apply to this specific medical needle as per the provided FDA documentation.

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