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The Spectranetics LLD E is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using the superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.015 -0.026 inches (0.38 - 0.66 mm) and a length less than 33.5 inches (85 cm).

The Spectranctics LI.D E is a percutaneous wire stylets that are placed inside the central lumen of a pacemaker or defibrillator lead as a fixation mechanism to provide traction for the extraction of the lead.

The Spectranctics LLD E is comprised of two (2) wire loop handles and a core mandrel that has a stainless steel mesh fixation mechanism. This mesh is attached at the distal end within a radiopaque marker for visibility under fluoroscopy. The proximal end of the mesh is attached to a proximal connector that is used to deploy and lock the device into the pacing or defibrillator lead.

The proximal connector is seated on a crimped section of the core mandrel until it is deployed. The connector slides from the crimped section and deploys the mesh inside the lead.

The tip of the LLD E is comprised of a platinum/iridium coil that is affixed to the tapered tip with the use of tin/silver solder. This coil allows the stylet better maneuverability around tight curves as compared to the predicate device. The platinum/iridium materials of the coil also allow for visualization of the stylet tip under fluoroscopy.

Here's an analysis of the provided text regarding the Spectranetics LLD E stylet, focusing on acceptance criteria and the supporting study information:

The document is a 510(k) summary for the Spectranetics LLD E, a locking stylet used for transvenous removal of chronically implanted pacing or defibrillator leads. The "study" described is primarily bench testing to demonstrate substantial equivalence to a predicate device, rather than a clinical trial with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for individual tests. It uses general terms like "samples tested."
• Data Provenance: The studies were retrospective bench tests performed by the manufacturer, The Spectranetics Corporation, in Colorado Springs, USA. There is no indication of clinical data or data from other countries.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. The "ground truth" for these bench tests would be the design specifications and predefined performance thresholds for the device and its components, as determined by the manufacturer's engineering and quality assurance teams. No external medical experts are mentioned as establishing ground truth for these specific bench tests.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would be conducted by qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a series of objective bench tests against engineering specifications, not evaluations requiring subjective judgment or consensus among multiple human reviewers. The "adjudication" would involve comparing test results to predetermined pass/fail criteria.

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

• Was it done? No. This document describes bench testing only. MRMC studies typically involve human readers (e.g., radiologists) interpreting medical images or data, which is not relevant to this device's pre-market submission type.
• Effect Size of AI Improvement: Not applicable.

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

• Was it done? Yes, in a sense. The described tests are all standalone device performance tests. The device itself (the stylet) is the "algorithm" here, and its performance characteristics (tracking, locking, strength, visibility) were evaluated independently in a simulated environment or through material testing. There is no AI or software algorithm involved.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Specifications: For mechanical tests (fatigue, tensile strength).
  • Predicate Device Performance/Design: For comparisons of dimensions, working length, and biocompatibility, the predicate LLD stylets served as a reference for equivalence.
  • Simulated Anatomical Models: For tracking and locking/unlocking capabilities.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a physical medical device, not a machine learning model that requires a training set. The "training" in the context of device development would refer to iterative design, prototyping, and testing, but not a formally defined "training set" of data.

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

• How Established: Not applicable, as there is no "training set" or AI model. The design and performance goals for the device were established based on the predicate device, engineering principles, and the intended use.

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