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The device is used to guide a biopsy needle to the target lesion for obtaining multiple biopsy samples.

The design of the Inrad Co-axial Introducer Needle as well as the predicate device, Manan Medical Products is referenced in the Comparison Information Section. The products are identically manufactured using the same manufacturing systems, design and materials. Both needles are manufactured by Manan Medical Products, Inc. The primary differences are packaging and sterilization which will be performed by Inrad.

This document is a 510(k) summary for a medical device called the "Inrad Co-axial Introducer Needle." It's a submission to the FDA to demonstrate substantial equivalence to a previously approved device, not a study describing acceptance criteria and performance data. Therefore, most of the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication is not present in this document.

However, I can extract the following relevant information:

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

This document does not contain explicit acceptance criteria or reported device performance data in the manner typically found in a study report for an AI/algorithm-based device. Instead, the "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to a predicate device.

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

• Not applicable. This document is for a physical medical device (co-axial introducer needle), not an AI or software device that would typically involve a test set with data. The proof of safety and effectiveness relies on the substantial equivalence to a legally marketed predicate device and the fact that they are "identically manufactured."

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. See point 2.

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

• Not applicable. See point 2.

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 physical medical instrument, not an AI or imaging diagnostic tool.

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

• Not applicable. This device is a physical medical instrument, not an algorithm.

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

• Not applicable in the context of an algorithm's ground truth. For this device, the "ground truth" for its safety and effectiveness is the historical performance and regulatory approval of the predicate device (Manan Medical Products, Inc. Co-axial Introducer Needle, K940024) and the assertion that the new device is "identically manufactured" and "proven to be safe and effective" by the predicate's market history.

8. The sample size for the training set:

• Not applicable. This document is not describing an AI model or algorithm that requires a training set.

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

• Not applicable. See point 8.

In summary: This 510(k) submission is for a physical medical device. The "study" described is a demonstration of substantial equivalence to an existing predicate device rather than a performance study with acceptance criteria and statistical data as would be performed for a novel or AI-powered diagnostic device. The basis for safety and effectiveness is largely the claim of identical manufacturing (design, materials, systems) to a device already on the market since 1994, with the only differences being packaging and sterilization by the new applicant.

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