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The Easy Core Detachable Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis. Soft tissue sampling includes but is not limited to organs such as breast, liver, kidney and prostate.

The Easy Core Biopsy System is a sterile, single-use biopsy needle.

The provided text is a K051361 Summary of Safety and Effectiveness for the Easy Core™ Detachable Biopsy System. It focuses on establishing substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria. The document primarily addresses regulatory aspects, intended use, biocompatibility, and the FDA's clearance.

Therefore, I cannot provide the requested information as it is not present in the given text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states a "Summary of Substantial Equivalence" declaring that "All data gathered demonstrate this device as substantially equivalent." However, it does not specify what "data gathered" refers to in terms of performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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 and not mentioned. This device is a biopsy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable and not mentioned. This device is a biopsy system, not an algorithm.
7. The type of ground truth used: Not mentioned, as no specific performance study against a ground truth is described.
8. The sample size for the training set: Not applicable and not mentioned. As this is not an AI/ML device, a "training set" in that context is not relevant.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

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