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The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

The Selectra CS lead introducer system is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into 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 Selectra Guiding Catheter is packaged with the following components: 1 Selectra CS guiding catheter (sterile), 1 dilator for the guiding catheter (sterile), 1 technical manual or web-card (non-sterile).

This document describes a Special 510(k) premarket notification for the BIOTRONIK Selectra 7F Guiding Catheters. The core of this notification is a device modification (reduction of Tungsten concentration and shelf-life extension) rather than a new device with novel performance claims. As such, the study design and acceptance criteria differ significantly from what would be expected for a device making claims based on algorithm performance.

Here's the breakdown of the information requested, based on the provided text:

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

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

The document does not specify a "test set" in the context of an algorithm or human performance study. Instead, it describes general "validation testing" for mechanical, packaging, sterilization, and shelf-life properties. Therefore, information on sample sizes for a clinical test set or data provenance (country, retrospective/prospective) is not applicable to this type of device modification submission. The studies were likely bench-top or accelerated aging tests.

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

This is not applicable. The submission is for a material and shelf-life change to a guiding catheter, not for a diagnostic or AI device requiring expert-established ground truth on patient data.

4. Adjudication method for the test set

This is not applicable. As there is no clinical test set requiring expert interpretation or consensus, there's no adjudication method.

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

This is not applicable. This is not an AI-powered device, nor does it involve human readers interpreting clinical cases.

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

This is not applicable. This is not an algorithm or AI device.

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

For the specific modifications (Tungsten concentration and shelf-life extension), the "ground truth" would be established through:

• Engineering specifications and material science: For the Tungsten concentration, the "truth" is its measured concentration and the resulting mechanical properties.
• Accelerated aging studies and real-time aging studies: For shelf-life, the "truth" is the device's ability to maintain its sterile barrier, material integrity, and functional performance over time, typically verified against pre-defined stability protocols and standards.
• Sterilization validation standards: For sterilization, the "truth" is achieving a specified sterility assurance level (SAL).

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a training set.

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

This is not applicable. There is no training set for this device modification.

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