Search Results

In conjunction with the Selectra accessory kit, Selectra guiding catheters are used to facilitate lead implantation in the heart chambers or in the coronary veins via the coronary sinus.

The Selectra lead introducer system is used to facilitate implantation of leads in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

Selectra accessories are used in conjunction with the lead introducer system to facilitate lead implantation in the coronary veins via the coronary sinus or to facilitate lead implantation into the heart chambers.

BIOTRONIK's Selectra lead introducer system is a combination of quiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various curve shapes and the Selectra accessory kit.

The Selectra Accessory Kit includes the following components in a single sterile package:

• 1 Selectra Slitter Tool .
• 1 quide wire ●
• 2 7F Transvalvular Insertion Tools (TVI) ●
• 1 syringe ●
• 1 torque tool ●
• 2 check valves ●
• 2 stopcocks
• 1 Tuohy Borst Adapter (TBA) ●

The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

The provided text describes a 510(k) premarket notification for a medical device, the "Selectra Lead Implantation System." This document is NOT about an AI/ML device, but rather a traditional medical device (a percutaneous catheter system). Therefore, most of the requested information about acceptance criteria, study design for AI/ML models (e.g., sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment), and AI-specific performance metrics is not applicable or present in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's what can be extracted from the document regarding acceptance criteria and performance data, re-framing it for a traditional medical device:

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

Since this is a 510(k) for minor modifications to an existing device, the performance data provided are primarily non-clinical bench testing to confirm that the modifications do not negatively impact safety and effectiveness and that the device continues to meet established performance criteria. The document states: "To demonstrate that the modified Selectra lead introducer system meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria for the predicate devices."

The specific values or detailed acceptance criteria for each test (e.g., "burst pressure > X psi" for functional testing) are not detailed in this summary document. Regulatory summaries typically only list the types of tests performed and the conclusion that they were "successfully performed."

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

• Sample Size: Not specified for the non-clinical tests. For bench testing, sample sizes are typically determined by engineering standards and statistical confidence limits, but these specifics are not in the provided summary.
• Data Provenance: Non-clinical test data, likely generated in a laboratory setting by the manufacturer (Biotronik, Inc.). This is retrospective as it was conducted prior to the 510(k) submission. No patient data or geographical provenance is applicable here.

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

• Not Applicable. This is a traditional medical device (catheter system) and not an AI/ML device. There is no concept of "ground truth" established by experts in the context of image interpretation or diagnosis for this specific device. Performance is assessed through engineering and biocompatibility testing.

4. Adjudication method for the test set:

• Not Applicable. As above, no expert adjudication is involved for this type of device's performance testing.

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. This is not an AI/ML diagnostic aid. No MRMC study was performed as it's not relevant to this device's function.

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

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• Not Applicable directly for "ground truth" as typically defined for AI/ML. For this device, the "ground truth" or reference for performance is established by engineering specifications, material standards, and successful function as an introducer system (e.g., ability to facilitate lead implantation without breakage, material non-toxicity, appropriate dimensions). The "ground truth" is adherence to pre-defined technical specifications.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. As above, no AI/ML training set.

Ask a specific question about this device