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The ScoutPro CS Lead Introducer System facilitates lead implantation in the left of the heart via the coronary sinus.

The ScoutPro accessories are used in conjunction with the ScoutPro CS Lead Introducer System to facilitate lead implantation in the left of the heart via the coronary sinus.

The ScoutPro family of introducer systems and accessories is specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus.

The provided text is a 510(k) Premarket Notification for modifications to BIOTRONIK's ScoutPro accessories. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the information required to populate the acceptance criteria table and describe a study proving the device meets those criteria is not present in the provided text.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Metrics: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for a diagnostic device; durability, success rates for an interventional device). Consequently, there are no reported device performance metrics against such criteria.
• No Clinical Study Details: The document describes modifications to existing devices (ScoutPro 8F guiding catheters) and relies on the concept of "substantial equivalence" to predicate devices. It explicitly states: "The usage of the ScoutPro 8F kit as well as all the ScoutPro 8F guiding catheters remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro accessories in submission #K060655, cleared on April 4, 2006." This indicates that a new clinical study to establish performance against new acceptance criteria was not conducted for this modification.
• Focus on Bench Testing and Equivalence: The mention of "a change in the tensile test procedure" suggests bench testing or non-clinical verification was performed to ensure the modifications did not negatively impact performance, but these are not clinical studies designed to meet acceptance criteria in the way you've described.

In summary, based only on the provided text, I cannot complete your request for a table of acceptance criteria and a detailed description of a study proving the device meets them because such information is not included in this type of regulatory submission for device modifications that rely on substantial equivalence.

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