(219 days)
Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.
The Temporary Cardiac Pacing Wire is a sterile single-use product. Temporary cardiac pacing wires consist of the following configurations and optional accessories:
- The monopolar leads consist of one insulated multifilament stainless steel conductor coated with colored polyethylene.
- The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle.
- The exposed, uninsulated section of the intracorporeal end of the wire is either straight or has one or more multiple pre-formed curves (pre-formed wave).
- The extracorporeal end of wire has a straight needle with breakaway tip attached.
- The wire length is 60 cm.
- Wires range in multiple diameters from 0 to 2-0, depending on the product code.
The provided text is a 510(k) Premarket Notification summary for a medical device called "Temporary Cardiac Pacing Wire." It describes the device, its intended use, and compares it to a predicate device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed device rather than proving the device meets a set of acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically for an AI/algorithm-based device. The device in this document is a physical medical device (cardiac pacing wire), and the "performance modification" mentioned refers to testing its compatibility with an MRI environment, not a software algorithm's performance.
To answer your request, if this were an AI/algorithm-based device, the document would need to outline the specific performance metrics (e.g., sensitivity, specificity, accuracy), the thresholds for those metrics (acceptance criteria), and details of a clinical or performance study (e.g., test set size, expert ground truth establishment, MRMC studies) to demonstrate that the algorithm met those criteria.
Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment for an AI/algorithm. The document focuses on showing substantial equivalence of a physical device with a predicate through design and material comparisons, and non-clinical performance testing related to MRI compatibility.
§ 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.