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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.

BIOTRONIK's Selectra lead introducer system is a combination of guiding 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 different 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 medical device clearance (K192996) for Biotronik's Selectra Catheters, Accessory Kit, and Slitter Tool. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel effectiveness. Therefore, the information provided is not a study proving de novo performance against specific acceptance criteria for a new AI/software-as-a-medical-device (SaMD) product.

The document states: "No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence." This indicates that extensive clinical studies, including those typically associated with AI/SaMD performance validation (like MRMC studies, standalone AI performance, expert ground truth establishment for AI training/testing), were not performed or required for this particular device clearance.

Instead, the performance data provided supports the substantial equivalence to a previously cleared predicate device (BIOTRONIK's Selectra 5F and 7F Catheters, Selectra Accessory Kit and Selectra Slitter Tool - K183265). The tests conducted were primarily engineering and quality control tests to confirm that minor modifications to the device and manufacturing processes did not negatively impact its performance or safety compared to the predicate.

Therefore, many of the requested criteria for AI/SaMD performance studies cannot be extracted from this document because they are not applicable to the type of device and clearance pathway described.

However, I can extract the available information as it pertains to the "acceptance criteria" and "study" for this specific device clearance, acknowledging that it's about substantial equivalence and not AI performance.

Acceptance Criteria and Device Performance (as reported for K192996 clearance)

Since this is a 510(k) for minor modifications to an existing device, the "acceptance criteria" and "performance" are implicitly defined by demonstrating that the modified device performs equivalently to the predicate device and meets established safety and functionality standards for a percutaneous catheter system.

1. Table of Acceptance Criteria & Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated in terms of number of devices tested for each category. These types of tests are typically done on a representative sample size determined by engineering and quality assurance protocols (e.g., ISO standards, internal validation plans) to ensure statistical confidence, but the specific numbers are not public in a 510(k) summary.
• Data Provenance: The tests were conducted by Biotronik, presumably at their facilities or certified labs. The location of the company is Lake Oswego, Oregon, USA. The data would be prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence of the modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not Applicable / Not Mentioned. This type of "expert ground truth" for a test set is typically relevant for interpretative devices (e.g., AI for diagnostics). For a percutaneous catheter system, "ground truth" relates to quantifiable physical and material properties and functional performance, verified through engineering and bench testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set:

• Not Applicable / None. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, particularly for AI validation. This device's testing involves objective measurements and standards, not subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification for a determination of substantial equivalence." MRMC studies are clinical studies involving human readers, and none were performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

• Not Applicable / No. This device is a physical medical instrument (catheter system), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance validation is based on engineering specifications, material science standards, established functional parameters, and safety benchmarks (e.g., biocompatibility standards, sterility assurance levels). It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be. The performance of the modified device was compared against the known, established performance of the predicate device.

8. Sample Size for the Training Set:

• Not Applicable. This is a hardware device, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As explained above, there is no AI training set for this device.

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The Selectra lead introducer system is used to facilitate implantation of leads in 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 different 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, 4 transvalvular insertion (TVI) tools, 1 syringe, 1 torque tool, 2 check valves, 2 stopcocks, 2 sealing caps. 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.

This document is a 510(k) summary for the BIOTRONIK Selectra Lead Introducer System. The submission, K183265, seeks to demonstrate substantial equivalence to previously cleared predicate devices.

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

The document explicitly states: "Performance data was not required to support this submission because no design change has been made." Therefore, there are no specific acceptance criteria for performance or reported device performance in this 510(k) summary. The submission is based on the premise that the device's technological characteristics are identical to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance data was required or provided in this submission because no design change was made.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No performance data was required or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No performance data was required or provided.

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 device is a medical instrument (lead introducer system), not an AI-assisted diagnostic or interpretative system.

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

Not applicable. This device is a medical instrument, not an algorithm.

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

Not applicable. No performance data was required or provided.

8. The sample size for the training set

Not applicable. No new performance data was generated or analyzed as part of this submission. The device is a physical medical instrument, not a learned algorithm.

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

Not applicable. No new performance data was generated or analyzed as part of this submission.

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