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The Pinpoint™ GT Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, PinpointTM GT Introducer Needle is an 18G x 2.75 inch needle designed for percutaneous access to introduce a guidewire. The PinpointTM GT Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with PinpointTM GT Technology. The PinpointTM GT Introducer Needle, when used with the PinpointTM GT System creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided text describes modifications to an introducer needle and asserts that the device meets acceptance criteria through various performance tests. However, it does not provide the detailed acceptance criteria and reported device performance in a table format, nor does it present a specific study with sample sizes, data provenance, ground truth establishment, or expert involvement as requested.

The document is primarily a 510(k) summary for the Pinpoint™ GT Introducer Needle, arguing for its substantial equivalence to a predicate device (Pinpoint™ GT Safety Introducer Needle). It lists the types of tests conducted and the standards/guidance documents followed, but not the results against specific acceptance metrics.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract the information that is present and clearly state what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states:
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."
However, the specific "predetermined acceptance criteria" and the "demonstrated performance" are not detailed in a table or any other format.

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

The document lists "Performance Testing - Bench" which implies physical bench tests of the device components.

• Sample size for test set: Not specified.
• Data provenance: Bench testing results, likely conducted internally by the manufacturer (C.R. Bard, Inc. / Bard Access Systems, Inc.). No information on country of origin of data, or if it was retrospective or prospective, as these are typically applicable to clinical studies, not bench tests like these.

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

This information is not applicable to the type of testing described (bench testing of a medical device's physical and functional properties). Ground truth and expert consensus are usually relevant for studies evaluating diagnostic accuracy or clinical outcomes, which are not detailed here.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above (bench testing, not clinical evaluation requiring human reader adjudication).

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

There is no indication of an MRMC study. The device is an introducer needle, not an AI diagnostic tool. While it interacts with an "ultrasound system equipped with Pinpoint™ GT Technology" to display a virtual image of the needle, the focus of this 510(k) is the needle itself and its substantial equivalence in physical and functional characteristics to a predicate device. The information provided does not suggest AI assistance for human readers in a diagnostic context.

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

This is not applicable. The device is a physical introducer needle, not a standalone algorithm.

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

As this involves bench testing of physical device attributes (e.g., tensile strength, dimensions, stiffness, echogenicity), the "ground truth" would be established by engineering and material standards, measurement tools, and physical inspection techniques to verify that the device meets its design specifications and relevant industry standards (e.g., ISO standards listed).

8. The sample size for the training set

This is not applicable. The context is the evaluation of a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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