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The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older 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. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing. The Zio AT device is designed to be used with the interoperable Zio ECG Utilization Service (ZEUS) SaMD which provides an arrhythmia detection algorithm for analysis and reporting.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zio AT device, organized as requested:

Device: Zio AT® device (A100A1001)

This premarket notification (K240177) is for an updated version of an already cleared device (Zio® AT ECG Monitoring Device [K240029]). Therefore, the submission primarily focuses on demonstrating substantial equivalence to the predicate device through non-clinical testing rather than presenting new clinical study data with detailed acceptance criteria and performance metrics for the device's diagnostic capabilities. The document explicitly states: "No clinical testing was performed in support of this premarket notification."

As such, many of the requested details related to clinical performance, such as detailed acceptance criteria tables, sample sizes for test sets, expert qualifications, and MRMC studies, are not available in this 510(k) summary. The acceptance criteria described here pertain to safety and engineering standards, not clinical accuracy for arrhythmia detection.

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

Since this is a 510(k) for substantial equivalence based on non-clinical testing for an updated device, the "acceptance criteria" are predominantly for engineering and safety standards, and the "reported performance" is that the device conforms to these standards.

Regarding the study that proves the device meets the acceptance criteria:

The study referenced is a comprehensive set of nonclinical performance testing. The document states: "All necessary performance testing was conducted on the Zio AT device to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device."

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

• Sample Size for Test Set: Not applicable/not provided for clinical performance. The nonclinical testing involves evaluating the physical device and its software against engineering standards. The sample size would refer to the number of devices or components tested to ensure compliance with specific technical standards (e.g., a certain number of units for electrical safety testing, material samples for biocompatibility), but specific quantities are not detailed in this summary.
• Data Provenance: Not applicable, as this is nonclinical (engineering/safety) testing.

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, as this document focuses on nonclinical testing and substantial equivalence, not clinical diagnostic performance requiring expert interpretation as ground truth.

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

Not applicable, as this document focuses on nonclinical testing, not clinical performance where adjudication of "ground truth" labels would be necessary.

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

No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This submission explicitly states "No clinical testing was performed in support of this premarket notification." The Zio AT device uses an arrhythmia detection algorithm (provided by the interoperable ZEUS SaMD), but the evaluation here is for the physical device's safety and engineering, not the diagnostic performance of the AI component.

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

This document does not provide details on standalone algorithm performance. The "Zio AT device is designed to be used with the interoperable Zio ECG Utilization Service (ZEUS) SaMD which provides an arrhythmia detection algorithm for analysis and reporting." While an algorithm exists, its performance is not detailed or assessed in this specific 510(k) submission as the focus is on the physical hardware's substantial equivalence to a predicate. Evaluations of the ZEUS SaMD's algorithm (which likely includes standalone performance) would have been part of previous submissions for that software.

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

For the nonclinical testing described, the "ground truth" would be the defined standards and specifications (e.g., a device passes the electrical safety test if it meets the voltage and current limits specified in IEC 60601-1). This is not clinical ground truth.

8. The sample size for the training set

Not applicable/not provided. This submission does not discuss the training of any AI algorithm, as it's a 510(k) for an updated physical device and primarily addresses nonclinical performance and substantial equivalence based on engineering and safety standards.

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

Not applicable/not provided for the same reasons as #8.

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