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The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

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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:

1. A table of acceptance criteria and reported device performance.
2. 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.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. 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.

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The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

Not Found

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria for the Carnation Ambulatory Monitor (CAM). The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device and provides general regulatory information and the Indications for Use.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test or training sets, nor data provenance.
3. Information about experts, ground truth establishment for the test set, or adjudication methods.
4. Details about MRMC comparative effectiveness studies or standalone algorithm performance.
5. The type of ground truth used (e.g., pathology, outcomes data).

Therefore, based solely on the provided text, it's not possible to answer the detailed questions regarding acceptance criteria and the study proving device performance.

Ask a specific question about this device

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:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone study was done
7. The type of ground truth used
8. The sample size for the training set
9. 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."

Ask a specific question about this device