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The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.

The SharkCore™ Fine Needle Biopsy (FNB) System is an echogenic biopsy needle used through the instrument channel of an ultrasound imaging endoscope. The system is used to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The SharkCore™ Fine Needle Biopsy (FNB) System is modular in design consisting of two major components; i.e., a delivery system (Beacon™ EUS Delivery System) and a separate exchangeable needle sub-assembly (SharkCore™ FNB Needle).

This document is a 510(k) premarket notification for a medical device called the SharkCore™ Fine Needle Biopsy System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial summary.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are not available in this document. This submission relies on bench testing and comparison to predicate devices, not human or clinical performance studies with specific metrics outlined in the request.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Available. The document states "Bench testing demonstrates performance equivalence" but does not specify the sample size of devices tested or the data provenance (e.g., country of origin, retrospective/prospective). This is a pre-market notification using bench testing, not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Available. No ground truth establishment by experts is described in this document, as it focuses on engineering and design equivalence through bench testing, not clinical performance requiring expert interpretation of results.

4. Adjudication method for the test set

• Not Applicable / Not Available. There was no human "test set" requiring adjudication in this 510(k) submission.

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

• Not Applicable. This device is a biopsy system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.

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

• Not Applicable. This device is a physical biopsy system, not an algorithm.

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

• Not Applicable / Not Available. As mentioned, the document focuses on bench testing for substantial equivalence, not clinical outcomes or diagnostic accuracy requiring a ground truth as defined in this question. The "ground truth" for the bench testing would have been engineering specifications and predicate device performance.

8. The sample size for the training set

• Not Applicable / Not Available. There is no "training set" as this is not a machine learning or AI device.

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

• Not Applicable / Not Available. As above, no training set or its ground truth is relevant or discussed.

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