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The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.

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I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions you've asked.

Therefore, I cannot extract the requested information from this document. If you can provide a document that describes the acceptance criteria and the study conducted for a device, I would be happy to analyze it and answer your questions.

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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.

Ask a specific question about this device