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The Vaxcel™ Plus Chronic Dialysis Catheter Tunneler is indicated to assist in tunneling and insertion of Vaxcel™ Plus Chronic Dialysis Catheters of corresponding size (19, 23, 28 cm).

The Vaxcel Plus Chronic Dialysis Catheter Tunneler is a slender, cylindrical device made of biocompatible stainless steel or delrin. The tunneler is designed to assist in tunneling the Vaxcel Plus Chronic Dialysis Catheters through subcutaneous tissue during catheter implantation. It has a tapered end, which is used to tunnel through subcutaneous tissue, and a barbed end for attachment of the dialysis catheter tip prior to tunneling.

The provided text describes a 510(k) submission for the Vaxcel™ Plus Chronic Dialysis Catheter Tunneler. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a detailed study like those for AI/ML-driven devices.

Therefore, the document does not contain the information required to populate the fields in your request regarding acceptance criteria, study details, expert involvement, or specific performance metrics. It primarily states that the device is substantially equivalent to a predicate device.

Here's why the information you're asking for isn't present in this type of document:

• Acceptance Criteria and Reported Device Performance: 510(k)s for non-AI devices typically don't present acceptance criteria in the format you described (e.g., Sensitivity, Specificity, AUC). Instead, they demonstrate that the new device meets the same safety and performance characteristics as a predicate device through various means (e.g., material testing, mechanical testing, functional testing if applicable, and comparison of design, manufacturing, and sterilization processes). The document states: "All performance characteristics are substantially equivalent to currently marketed devices."
• Sample Size, Ground Truth, Experts, Adjudication, MRMC studies, Standalone studies, Training Set: These concepts are relevant for studies evaluating the performance of AI/ML algorithms, especially in diagnostic imaging or similar fields. The Vaxcel™ Plus Chronic Dialysis Catheter Tunneler is a physical medical device (a catheter tunneler), not an AI algorithm. Therefore, these types of studies and methodologies are not applicable to its regulatory submission.

Summary based on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The underlying acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device in terms of safety and effectiveness. This implies that the device must perform similarly to the predicate device in its intended use.
   • Reported Device Performance: "All performance characteristics are substantially equivalent to currently marketed devices." No specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are provided, as this is a physical device, not a diagnostic algorithm.

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to a physical medical device, not an AI/ML algorithm requiring a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

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 concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Explanation of the "Study" mentioned in the document:

The "study" or assessment performed for this device, as implied by the 510(k) submission, involved demonstrating that its "design characteristics, manufacturing, and sterilization processes are identical to the predicate devices" and that "all performance characteristics are substantially equivalent to currently marketed devices." This typically involves:

• Design comparison: Reviewing specifications, materials, dimensions, and functionality against the predicate device.
• Material biocompatibility: Ensuring materials are safe for human contact.
• Mechanical/Functional testing: If applicable, demonstrating the device can withstand expected forces or perform its mechanical function (e.g., strength of the tunneler, secure attachment of the catheter).
• Sterilization validation: Ensuring the sterilization process is effective.

These are not "studies" in the context of clinical trials or performance assessments for AI algorithms, but rather engineering and regulatory compliance evaluations.

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