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The Zio Monitor is a prescription-only, single-patient-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue or anxiety.

The Zio monitor is a non-sterile, single-patient-use, long-term ambulatory ECG monitor that is adhered to a patient's left pectoral region in a modified Lead II orientation. The goal of the Zio monitor is to help physicians initiate long-term, patient-compliant ECG monitoring utilizing proprietary technology.

The Zio monitor is applied and activated by the patient at home or at a clinic. Once activated, the device provides continuous, uninterrupted ECG recording into memory with minimal patient interaction. There is a button on the surface of the Zio monitor, which serves to activate the device and may be pressed by the patient during wear to indicate when he or she is experiencing a symptom. Additionally, there is a surface LED light that blinks green to confirm proper activation or that the device is working, and orange to indicate loss of connection with the skin or the presence of error conditions.

Although the provided document is a 510(k) summary for the Zio Monitor, it explicitly states that no clinical testing was performed in support of this premarket notification. Therefore, the document does not contain information about acceptance criteria based on clinical performance, a study proving device performance against such criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or grand truth details for either test or training sets.

The document focuses on demonstrating substantial equivalence to a predicate device (Zio XT Patch) through nonclinical testing, changes in technological characteristics (reduced weight and power), and adherence to recognized consensus standards and guidance documents.

Here's an analysis of the provided information, noting the absence of the requested clinical performance details:

1. A table of acceptance criteria and the reported device performance

   • The document states: "There are no required FDA performance standards for the Zio monitor. All necessary performance testing was conducted on the Zio monitor to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device."
   • It lists several nonclinical tests (Mechanical verification, Biocompatibility, Firmware verification, Electrical safety and EMC, and packaging tests conforming to ASTM standards) and mentions conformance to various ISO/AAMI/IEC standards (Table 2).
   • However, specific quantitative acceptance criteria and their corresponding reported device performance values from these nonclinical tests are not detailed in this summary. The summary only asserts that the device meets these standards and specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable / Not provided. No clinical test set was used as no clinical testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not provided. No clinical test set requiring expert ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable / Not provided. No clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable / Not provided. No clinical testing, including MRMC studies, was performed. The device itself is an ECG monitor, not explicitly described as having AI assistance for human readers in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable / Not provided. No clinical or algorithm-only performance study was conducted or reported in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable / Not provided. No clinical ground truth was established as no clinical testing was performed. For the engineering/nonclinical tests, the "ground truth" would be the specifications and standards themselves.

8. The sample size for the training set

   • Not applicable / Not provided. No machine learning or AI algorithm requiring a training set is discussed or implied to have been evaluated clinically in this document.

9. How the ground truth for the training set was established

   • Not applicable / Not provided. As no training set is mentioned, its ground truth establishment is also not applicable.

In summary, the provided 510(k) summary for the Zio Monitor focuses on demonstrating substantial equivalence through nonclinical conformity and engineering specifications rather than clinical performance data. Therefore, the requested information regarding acceptance criteria derived from clinical studies and their supporting evidence is not present in this document.

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