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The Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.

The Tuohy Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub. The Tuohy Epidural Needle will be provided as a sterile, single use, disposable device. The Epidural Needle will be available in a variety of lengths and gauges.

The provided document, K030562 pertaining to the Tuohy Epidural Needle, does not contain information related to acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven medical device.

This document is a 510(k) summary for a traditional medical device (an epidural needle) and focuses on establishing substantial equivalence to a predicate device. Therefore, none of the requested information regarding AI/algorithm performance, ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies is present or applicable.

Here's a breakdown of why the information is not present based on the provided text:

• Device Type: The device is a "Tuohy Epidural Needle," a physical medical instrument, not an AI or algorithm.
• Regulatory Pathway: The submission is a 510(k) for substantial equivalence, which primarily involves comparing the new device to a legally marketed predicate device, rather than demonstrating de novo performance against specific criteria through a clinical or algorithmic study.
• Non-Clinical Data Section: The document explicitly states: "Due to the fact that this product is purchased by Epimed from Manan Medical and is identical to the predicate device, bench testing to compare performance characteristics was not conducted." This confirms that no specific performance studies were performed for this particular submission.
• Conclusion: The conclusion focuses solely on substantial equivalence to the predicate device, not on meeting predefined performance criteria through a study.

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

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