(268 days)
The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a cardiovascular stimulating instrument to a cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.
The Model 5944RL rotatable connector is a pair of single use, disposable surgical cables with two adaptors. The cables are designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead system.
The provided document is a 510(k) Premarket Notification Submission for a medical device called "Rotatable Connector (5944RL)". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results to prove meeting specific acceptance criteria in the way a diagnostic AI/ML device would.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the context of an AI/ML or diagnostic device.
Specifically, the document states:
- "The subject of this premarket submission did not require clinical studies to support substantial equivalence." This means no clinical trials were performed to establish the device's performance against specific clinical acceptance criteria.
- The comparison is primarily focused on technical characteristics, intended use, and safety standards against a predicate device.
Given this, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: No such clinical performance metrics or acceptance criteria are listed.
- Sample sizes used for the test set and the data provenance: No test set or data provenance from a clinical study are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical test set for ground truth establishment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a physical medical device (a connector), not an AI/ML diagnostic.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on non-clinical tests (e.g., biocompatibility, sterilization, electrical safety) to demonstrate substantial equivalence to a previously cleared predicate 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.