(56 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 FDA 510(k) clearance letter for the Bardy Diagnostics Carnation Ambulatory Monitor does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them.
The document is an FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It refers to general controls, quality system regulations, and provides contact information for regulatory inquiries.
Specifically, the letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance. This information would typically be found in the 510(k) submission itself, not the clearance letter.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Details about a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this type of detailed performance data and study design, one would typically need to review the full 510(k) submission available through the FDA's public database (though not all components of the submission are always publicly accessible in detail). The provided document is a summary clearance letter.
§ 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).