(77 days)
The Zio Patch is a prescription-only, single-patient-use, continuously recording ECG monitor that can be worn up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety.
continuously recording ECG monitor that can be worn up to 14 days
The provided text is a 510(k) clearance letter for the Zio® Patch, an ECG monitor. It does not contain the detailed study information required to answer the prompt.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this document.
The document only states the device's indications for use and confirms its substantial equivalence to predicate devices. It does not include a technical report or clinical study summary with the performance data.
§ 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).