(307 days)
The ECG3 is intended for use in a community hospital or at home and it is a dynamic electrocardiogram measurement system. It is designed to measure and record ECG data of an adult individual in the long term by using a technique in which an electrode was pasted on the chest.
The ECG3 Portable ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.
Not Found
This FDA letter acknowledges the clearance of the Portable ECG Monitor (model ECG3) but does not contain information about acceptance criteria or the study that proves the device meets those criteria. The provided text is a 510(k) clearance letter, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not include the detailed performance study results that would typically be found in the 510(k) submission itself.
Therefore, I cannot provide the requested information based on the given input. The document does not describe:
- Acceptance criteria and reported device performance in a table.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study information.
- Standalone performance study results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, you would need to access the full 510(k) submission for K172862, which is typically a much more extensive document than the 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).