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The Wilson-Cook Celiac Plexus Neurolysis Needle is used to deliver neurolysing agents to the celiac plexus under guidance by endoscopic ultrasound. It is supplied sterile and is intended for single use only.

The Wilson-Cook Celiac Plexus Neurolysis Needle is comprised of a stainless steel echogenic pencil point needle with four side openings toward the tip. The handle allows a stroke of approximately 8-cm to advance the needle into position. The outer sheath of the device is comprised of polytetrafluoroethylene.

This document is a 510(k) premarket notification for a medical device, the Wilson-Cook Celiac Plexus Neurolysis Needle. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study involving patient outcomes or complex metrics.

Therefore, much of the requested information about acceptance criteria, study design, expert involvement, and ground truth is not present in this type of regulatory document. The document describes a "simulated use testing and clinical evaluation," but the specifics of these "tests" are not detailed in a way that allows for a breakdown according to the request.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Inferred from "Substantial Equivalence" and "Discussion of Tests"): For a 510(k), the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as existing legally marketed predicate devices. This is achieved by showing similar technological characteristics and intended use, and that performance testing (even if not explicitly detailed with specific pass/fail metrics) supports this equivalence.
  • Simulated Use Testing: The device must perform as intended during simulated use.
  • Clinical Evaluation: The device must perform as intended during clinical evaluation.
  • Biocompatibility/Sterility/Shelf Life: While not explicitly stated as "acceptance criteria," these are standard requirements for medical devices, and their successful completion would be implicit in obtaining 510(k) clearance.
• Reported Device Performance:
  • "Test results provide reasonable assurance the device will perform in accordance with its intended use."
  • "Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Celiac Plexus Neurolysis Needle meets the requirements for 510(k) substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document mentions "simulated use testing and clinical evaluation" but gives no details about sample size (e.g., number of uses, number of patients), or data provenance. In a 510(k) summary, clinical data might be extremely limited or not present if substantial equivalence can be shown through other means (e.g., bench testing, comparison to predicate).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. This type of detail is typically associated with studies involving diagnostic accuracy or interpretations where expert consensus defines "ground truth." This document is for a medical device (a needle) and its functional performance, not a diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication methods are relevant for studies where a "ground truth" needs to be established from multiple expert opinions (e.g., imaging studies). This is not that kind of study as described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not relevant to the type of device (a physical needle) or the regulatory submission (510(k) for substantial equivalence of a device, not an AI diagnostic tool).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This question pertains to AI algorithms. The device is a surgical needle.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Functional performance and safety. For a device like a needle, "ground truth" would likely relate to its functional attributes:
  • Ability to penetrate tissues (simulated or cadaveric).
  • Ability to deliver agents to the celiac plexus.
  • Integrity of the needle (no breakage, bending).
  • Flow rate suitability.
  • Biocompatibility.
  • Sterility maintenance.
  • These are assessed through engineering tests, simulated use, and potentially limited clinical observation, not typically "expert consensus" on an image or pathology.

8. The sample size for the training set

• Not applicable/Not provided. This concept is relevant for machine learning algorithms. The device is a physical medical instrument.

9. How the ground truth for the training set was established

• Not applicable/Not provided. Same as above.

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