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The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.

Braemar ER900 Series Enhanced Algorithm ECG Event Recorder

The provided text is a 510(k) premarket notification letter from the FDA to Braemar, Inc. regarding their ER900 Series Enhanced Algorithm ECG Event Recorder. This document does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on its substantial equivalence to a predicate device, not necessarily through a formal study with detailed acceptance criteria and performance metrics described in this specific document. The FDA's 510(k) pathway often relies on demonstrating equivalence rather than requiring extensive clinical trials with predefined performance endpoints for novel devices.

Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text. The information regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, and ground truth establishment would typically be found in the manufacturer's 510(k) submission, which is a much more extensive document than the FDA's clearance letter.

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