(112 days)
The BIOTRONIK PX-BP and PX-JBP pacing leads are safe and effective bipolar, transvenous, implantable, endocardial leads used with implantable cardiac pacemakers.
The BIOTRONIK PX-BP and PX-JBP pacing leads are safe and effective bipolar, transvenous, implantable, endocardial leads used with implantable cardiac pacemakers. The lead body insulation of all PX-BP/PX-JBP endocardial leads is NuSil silicone rubber tubing, with the conductor of quadrafilar MP35N.
The PX-BP/PX-JBP endocardial leads provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip. The tip has undergone a Physical Vapor Deposition (PVD) treatment of iridium over titanium, creating a fractal-surfaced ball-like microstructure. Passive fixation in the heart's trabeculae is provided by four flexible silicone rubber tines. The ring electrode (anode) of the bipolar lead is made of platinum/iridium, also with a fractal iridium surface treatment. The IS-1 connection system of PX-BP/PX-JBP leads complies with the International Standard ISO 5841.3:1992: Low Profile Connectors. The PX-JBP lead is pre-formed into a "J" shape for optimal positioning in the atrium.
This document describes a medical device, the BIOTRONIK PX-BP and PX-JBP pacing leads, and its safety and effectiveness. However, it does not describe an AI/ML device or a study involving acceptance criteria for an AI/ML system.
Therefore, many of the requested categories in your prompt are not applicable to the provided text.
Here's a breakdown of what can be extracted and why other parts are not relevant:
1. A table of acceptance criteria and the reported device performance
The document focuses on qualification testing and biocompatibility rather than specific, quantified acceptance criteria for an AI/ML output. The "acceptance criteria" here are implied by "All test results were within specifications."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Biocompatibility | Acute and chronic biocompatibility tests performed; long term implantation studies completed; corrosion studies completed; iridium confirmed safe for use. |
| Mechanical/Electrical Qualification Testing | Crimp and weld strength of connections, fatigue strength, DC resistance, environmental resistance, adherence to IS-1 standards, stylet performance, packaging and transportation durability, lead tip testing, and sterilization validation. All test results were within specifications. |
| IS-1 Connection System Compliance | Complies with International Standard ISO 5841.3:1992: Low Profile Connectors. |
| Long-term Pacing Effectiveness | "provide long-term safe and effective pacing due to the surface structure of the lenticular electrode tip." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Testing: Not explicitly stated as a single "test set" in the context of AI. The document refers to various tests without detailing the number of units tested for each.
- Data Provenance:
- In-vitro and Qualification Testing: Conducted by the manufacturer.
- Clinical Experience: Stated as "Field clinical experience" and "European market in 1996" with "over 1400 leads sold outside of the United States, as of October 1, 1996." This suggests a combination of prospective (for market monitoring) and retrospective (analysis of existing market data) data. The country of origin for the clinical experience is primarily Europe.
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. This is not an AI/ML study, so there is no "ground truth" to be established by experts for an algorithm's output. The "truth" in this context is determined by physical and biological testing and clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for an algorithm's output is mentioned.
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 study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the safety and effectiveness of these leads is established through:
- Biocompatibility testing: Chemical, cellular, and tissue responses.
- Material science characterization: Verification of material properties and corrosion resistance.
- Mechanical and electrical engineering testing: Adherence to specifications for strength, fatigue, resistance, etc.
- Compliance with International Standards: e.g., ISO 5841.3:1992.
- Clinical outcomes/observations: "Field clinical experience" and "Lead Complications" table summarizing observed issues and potential corrective actions.
8. The sample size for the training set
Not applicable. This is not an AI/ML study; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML study.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.