(59 days)
The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.
Not Found
This document is an FDA 510(k) clearance letter for the Bardy Diagnostics, Inc. Carnation Ambulatory Monitor. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.
Based on the provided text, I cannot answer the questions about:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document only confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls of the Act. It states the indications for use: "The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias."
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).