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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.

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The Zio® Patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

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The provided text from the FDA 510(k) summary only covers basic information about the Zio® Patch, its regulation, and approval. It does not contain any information regarding acceptance criteria, study details, or performance data.

Therefore, I cannot provide answers to your specific questions based on the given document.

To answer your questions, I would need a more detailed performance study report or clinical trial summary for the Zio® Patch, which typically includes:

• Specific endpoints (acceptance criteria)
• Statistical methods
• Sample sizes
• Ground truth establishment
• Adjudication
• Results compared to the acceptance criteria.

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The Zio TM patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days. It is indicated for use on patients who experience transient symptoms such as syncope, palpitations, shortness of breath, or chest pains.

The Zio TM patch is a prescription only single patient use, continuous recording ECG monitor that can be worn for up to 14 days.

This document is a 510(k) clearance letter for the Zio™ patch Model Z100 from the U.S. FDA, dated May 8, 2009. It primarily grants market clearance and defines the indications for use. It does not contain detailed information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information based on the provided text. The document is for regulatory clearance and states that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data or study details.

Ask a specific question about this device