(108 days)
The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.
The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead which contains a distal, discrete, ring electrode (1), a discrete, tip electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto a conductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins (6). To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.
The provided text is a 510(k) premarket notification for a medical device: the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead. This document is focused on establishing "substantial equivalence" to a predicate device, specifically due to a material change in a component (shrink band).
The information requested in the prompt, particularly regarding acceptance criteria and studies proving device performance in the context of AI/machine learning (e.g., ground truth, expert consensus, MRMC studies, training/test set sample sizes), is not present in this document. This document pertains to a traditional medical device (a pacing lead), not an AI-enabled one. Therefore, the questions related to AI-specific performance metrics, ground truth establishment, and training/test sets are not applicable to the content provided.
The document primarily focuses on:
- Device Description: What the pacing lead is and how it functions.
- Intended Use: Temporary post-surgical pacing for 7 days or less.
- Comparison to Predicate Device: Emphasizing similarity in intended use, performance (claimed as substantially equivalent), principles of operation, technology, design, and materials.
- Description of Change: The specific change being submitted – a material change to the shrink band.
- Summary of Testing: Only lists "Biocompatibility" and "Manufacturability" tests for the new shrink band material, both of which "Passed." These are standard tests for material changes in medical devices, not performance studies of an AI algorithm.
- Conclusion: States that the device is substantially equivalent to the legally marketed predicate device based on the data submitted.
To directly answer your prompt based only on the provided text, many fields will be "Not Applicable" or "Not Provided" because the document describes a physical medical device, not an AI/ML algorithm.
Here's how the provided information maps to your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility (for new shrink band material) | Passed |
| Manufacturability (for new shrink band material) | Passed |
| Substantial Equivalence to Predicate Device | Concluded as Substantially Equivalent |
| Safety and Effectiveness (implied by 510(k) process) | Concluded as having reasonable assurance of safety and effectiveness |
Note: The document doesn't explicitly state quantitative acceptance criteria beyond "passed" for the listed tests. The overarching "acceptance criterion" for a 510(k) is demonstrating substantial equivalence.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any testing. The testing summary is very high-level ("Tests conducted").
- Data Provenance: Not specified.
- Retrospective or Prospective: Not applicable, as this refers to clinical study design which is not detailed here for this device.
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 document describes a physical pacing lead, not an AI/ML device requiring expert-established ground truth for image/data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This refers to expert consensus in AI/ML performance evaluation, which is not relevant here.
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
- No. An MRMC study is not relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth, in the context of AI/ML, is not relevant for the testing described for this physical device. The "ground truth" for the device's function would be its demonstrated physical and electrical properties, and biocompatibility, as tested in labs, not human interpretation or outcomes analysis as in an AI study.
8. The sample size for the training set
- Not Applicable. There is no AI training set for this device.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI training set or ground truth establishment relevant to AI for this device.
§ 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.