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The VMCore biopsy needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissues, such as the prostate, lung, kidney, or liver. The VMCore biopsy needle is not intended for use in bone.

The VMCore Biopsy Needle Set is a set of two disposable needles used for collection of tissue samples. The set consists of an Outer Cannula and the Core Collector. The needles are made of stainless steel and have a plastic hub attached at their proximal ends.

The provided text describes a 510(k) summary for the VMCore Biopsy Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a clinical study with detailed metrics like sensitivity, specificity, or AUC, which are common for AI/ML-based medical devices.

Therefore, the information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy, along with details about study design (sample size, ground truth, expert adjudication, MRMC studies, effect size, standalone performance, training set details), is not present in the provided document.

This submission focuses on:

• Intended Use and Indications for Use: Demonstrating the VMCore Biopsy Needle has the same intended use as the predicate device (obtaining soft tissue biopsies).
• Technological Characteristics Comparison: Showing that the VMCore Biopsy Needle has technological characteristics similar to its predicate device (RP Cutting Needle, K092059) and a reference device (Reprise Bladder Injection System, K180214). This includes materials, dimensions, mechanism of action, and accessory devices.
• Performance Data (Non-Clinical): Providing testing results for biocompatibility and mechanical properties to show that the new device does not raise new questions of safety and effectiveness.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of diagnostic accuracy for this submission. The "acceptance criteria" presented are related to non-clinical performance and substantial equivalence, not statistical measures of diagnostic performance typically associated with AI/ML devices.

Non-Clinical Performance Data (as reported):

• Volume of tissue collection in an in vitro model.
• Volume of tissue collected from 3 different depths of insertion in an in vitro model.
• Measurement of the tissue weight collected in the first and last sample from an in vitro model.
• Strength of the attachment of the hub to the needle.
• Bend strength of the needle cannula. |

Important Note: For each mechanical test, the document states what was measured but does not provide specific numerical outcomes or pre-defined acceptance limits (e.g., "volume of tissue collected was X mL, meeting criterion of > Y mL"). It simply states that the testing "establishes that the VMCore Biopsy Needle does not raise new questions of the safety and effectiveness."

Missing Information (for an AI/ML diagnostic device study):

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing of a physical biopsy needle.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device. The "ground truth" for a biopsy needle's performance is typically its ability to collect a tissue sample suitable for pathological examination, and its safety/material properties.
8. The sample size for the training set: Not applicable. There is no AI/ML algorithm involved requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (biopsy needle), not an AI/ML-based diagnostic device. Therefore, the detailed performance metrics and study design elements you requested, which are typical for AI/ML device evaluations, are not present in this submission.

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