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BIOTRONIK's ELOX P transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.

The ELOX P lead models are intended for placement in either the right atrium or right ventricle.

Elox P leads are straight, bipolar endocardial pacing leads that utilize an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal tridium coating. The fixation helix is additionally coated with Parylene C. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The leads contain two conductors composed of quadrifilar MP35N wire in coaxial configurations and are insulated with silicone tubing. A 3.2 mm 15-1 bipolar connector attaches the lead to the pulse generator. The Elox P lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.

Here's an analysis of the provided text regarding the Elox P Active-Fixation Endocardial Lead, focusing on acceptance criteria and study information.

It's important to note that this document is a Special 510(k) Notification, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical study results with specific acceptance criteria in the same way a PMA or a de novo application might. Therefore, some of the requested information (like specific effect sizes of AI-assisted vs. human readers, or detailed ground truth establishment for a test set) is not directly applicable or present in this type of submission.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "reported device performance" for a new, standalone clinical study demonstrating efficacy in the way a pharmaceutical trial or a software AI product might. Instead, the core of this Special 510(k) is to demonstrate that the modified Elox P lead is substantially equivalent to its predicate devices (existing Elox leads and other cleared pacemaker leads).

The key "performance" being evaluated for this modification (addition of Parylene C coating to the fixation helix to increase electrical impedance) would be that the lead continues to meet established performance standards for pacemaker leads and that the modification doesn't adversely affect safety or effectiveness. The comparison is primarily against the performance of the predicate Elox leads which have already undergone testing and received clearance.

For pacemaker leads, substantial equivalence is often demonstrated through:

• Bench testing: Electrical performance (e.g., impedance, current leakage), mechanical properties (e.g., tensile strength, fatigue), material biocompatibility.
• Animal studies: To assess acute and chronic pacing and sensing performance, fixation, and tissue response.
• Clinical experience/literature review: Referencing the known performance of the predicate device.

Given this is a Special 510(k), the focus is on a modification and demonstrating that the modified device is as safe and effective as the original. The performance criteria are implicitly those that a pacemaker lead must meet to be considered safe and effective, as established by prior device clearances and relevant standards.

Implicit Acceptance Criteria and Demonstrated Performance:

Study Information (as inferable from the document type)

This document is a Special 510(k) focusing on a device modification. It refers to predicate devices for establishing substantial equivalence rather than presenting a detailed new clinical study with a prospectively defined test set and ground truth.

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

   • Test Set Sample Size: Not applicable in the context of a new, standalone clinical test set as described for AI algorithms. The "test set" here refers to the comprehensive data (bench tests, biocompatibility tests, potentially limited animal or pre-clinical data, and comparison to predicate device data) used to demonstrate substantial equivalence of the modified device. No specific patient sample size is provided for a new clinical study.
   • Data Provenance: The modification is described by BIOTRONIK, Inc. (USA) and manufactured by BIOTRONIK GmbH & Co. (Germany) and BIOTRONIK AG (Switzerland). The data would originate from their internal testing and regulatory submissions. The nature of a Special 510(k) means this data would be primarily retrospective in terms of referencing the performance of the predicate device and potentially prospective for specific bench or animal tests on the modified component.

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

   • Not applicable in this type of submission. "Ground truth" in the context of a pacemaker lead's performance is established through objective measurements (e.g., electrical impedance, mechanical strength), animal studies, and long-term clinical observation of predicate devices. There isn't an "expert consensus" on imaging or diagnostic interpretation similar to an AI algorithm.

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

   • Not applicable. This concept is typically relevant for studies where human expert disagreement needs to be resolved for ground truth labeling (e.g., radiological interpretation).

4. 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 pacemaker lead, not an AI diagnostic algorithm. There are no "human readers" interpreting data with or without AI assistance in this context.

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

   • Not applicable. This device is a hardware medical device (pacemaker lead), not a standalone algorithm.

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

   • For a pacemaker lead, "ground truth" for proving safety and effectiveness involves a combination of:
     • Objective physical measurements: Electrical parameters (impedance, current), mechanical strength/durability.
     • Biocompatibility testing: Standardized tests (e.g., ISO 10993 series) on materials.
     • Animal study results: Acute and chronic pacing/sensing, tissue response, lead fixation.
     • Clinical performance of predicate devices: Long-standing data on similar devices provides the most significant "ground truth" for the overall concept and previous versions of the product.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" in the context of this pacemaker lead modification.

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

   • Not applicable, as there is no training set.

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