(28 days)
Pacing Lead Adaptors/Extensions, unipolar/bipolar are indicated for connecting the pacing lead(s) to a compatible pacemaker header cavity.
Not Found
I am sorry, but based on the provided document, I cannot extract the acceptance criteria and study details you requested. The document is a 510(k) clearance letter from the FDA for "Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors". It primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory obligations.
The document does not contain:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes for test or training sets.
- Details on expert involvement, ground truth establishment, or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
Therefore, I cannot fulfill your request for this specific document.
§ 870.3620 Pacemaker lead adaptor.
(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”