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for use with implantable drug delivery ports and catheters and for use in the subcutaneous positioning of long-term vascular access catheters and subcutaneous ports.

comprised of biosafe materials, such as stainless steel. composed of an angled stainless steel shaft.

The provided text describes a 510(k) Premarket Notification for the Auto Suture® Chemosite® Tunneler. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices that are similar to devices already on the market.

Crucially, this type of submission (510(k) for substantial equivalence) does not typically involve a study to prove acceptance criteria in the way described in your request (e.g., performance metrics like sensitivity, specificity, or reader improvement). Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot extract the information you've requested regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these elements are not part of a substantial equivalence claim for a physical medical device like a tunneler. Such studies are more common for diagnostic devices, AI/ML-based products, or devices requiring clinical trials for novel claims.

The document highlights the following points for substantial equivalence:

• Similar Indications for Use: Both the Auto Suture® Chemosite® Tunneler and the Davol® Tunneler are used with implantable drug delivery ports/catheters and for subcutaneous positioning of long-term vascular access catheters and subcutaneous ports.
• Similar Materials: Both the Auto Suture® Chemosite® Tunneler and the Cook™ Trocar Tunnelator™ are made of biosafe materials like stainless steel.
• Similar Design: Both the Auto Suture® Chemosite® Tunneler and the Cook™ Trocar Tunnelator™ have an angled stainless steel shaft.
• Similar Manufacturing, Packaging, and Sterilization: The Auto Suture® Chemosite® Tunneler and the Auto Suture® Chemosite® Implantable Drug Delivery System (K952748) are manufactured, packaged, and sterilized in similar facilities with similar materials, process methods, and controls.

In summary, the provided text is a regulatory submission focused on substantial equivalence, not on a performance study with defined acceptance criteria for metrics like accuracy, sensitivity, or specificity.

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