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The external pacemaker PACE 101 H is designed for temporary stimulation of the heart in case of rhythm disturbances and conduction defects. According to present clinical experience, the instrument is especially suited for stimulation of the heart in the following cases:

• treatment of patients before an operation, whereby an implantable pacemaker is . being inserted;
• treatment of tachyarrhythmia; ♥
• treatment of special cases of acute myocardial infarction; .
• treatment of patients after heart surgery.

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The provided document is a 510(k) clearance letter from the FDA for a device called "PACE 101 H External Pacemaker". This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than a new clinical study demonstrating its performance against specific acceptance criteria. The 510(k) process often relies on comparison to a legally marketed device and its known performance, rather than requiring a detailed clinical trial with pre-defined acceptance criteria and reported device performance in the same way a Premarket Approval (PMA) application would.

Therefore, I cannot provide the requested information from this document.

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