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Spinal Needle (Quincke Bevel and Pencil Point) is intended for injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management. The device is intended to be used in a professional healthcare environment and not tested for MRI safety.

Spinal Needles are long, flexible needles of small gauge (typically 18G to 27G) which are available with different types of tips: Pencil point and Quincke bevel. The Spinal Needles are available in a series of combination of needle size and length. The smaller size needles of Pencil point tip are provided with introducer needles to provide support for accessing the tough tissues. Spinal needles have a removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needle hub is luer connector (6% luer taper).

The provided text is a 510(k) premarket notification for a medical device (Spinal Needle). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than describing an AI/ML algorithm's performance. As such, it does not contain the information required to answer the prompt regarding acceptance criteria and performance studies for an AI/ML device.

Specifically, the document states: "No clinical data was included in this premarket application submission." and the detailed sections relate to physical and chemical properties, sterilization, and material compatibility, not AI system performance.

Therefore, I cannot provide the requested information from the given text.

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