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The QOCA Portable ECG Monitoring Device is intended to capture continuous electrocardiogram (ECG) information for long-term (up to 14 days). It is indicated for use on adult patients 21 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, ECG and heart rate data are stored in the device for later viewing by healthcare professionals.

The QOCA Portable ECG Monitoring Device consists of 3 parts: a rechargeable and reusable ECG sensor with Bluetooth technology, a single-use electrode and hydrogel patch, and an optional mobile platform app (QOCA ecg App). The QOCA Portable ECG Monitoring Device provides a continuous, single-channel recording for up to 14 days. The QOCA Portable ECG Monitoring Device records ECG without patient interaction, and patients have the option of pressing the power button on the ECG sensor to trigger an event record. Patients can also choose to use the QOCA Portable ECG Monitoring Device along with a mobile platform app so that the event trigger can be triggered with the App and the data can be transmitted via BLE from the ECG sensor to the mobile platform for display. The subject device provides operational alarms such as lead off detection and battery monitoring. The operational alarms display on both the sensor and QOCA ecg App to inform the patient of the operation status of the sensor. The subject device does not provide any alarms based on physiological data setting. After the recording period (up to 14 days) ends, the patient returns to his/her healthcare provider, and the data stored in the sensor can be transferred to the computer by connecting with a USB cable and viewed with QOCA ecg Reader, a non-device MDDS for displaying data. The device is intended to be used on general care patients who are 21 years of age or older. This device is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis. This device is not intended to be used for real-time and/or continuous patient monitoring.

The provided text describes the QOCA Portable ECG Monitoring Device and its substantial equivalence to a predicate device, the ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service. However, it does not contain information about:

• Specific acceptance criteria values for device performance (e.g., accuracy percentages for heart rate detection or ECG capture).
• A clinical study performed to prove the device meets these criteria. The document explicitly states: "The ECG signal recorded by this device is not intended for automated analysis. This device is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software." This indicates that there was no algorithm with its own performance metrics validated.
• Sample sizes used for a test set, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, type of ground truth used for testing, training set sample size, or how ground truth was established for training data. These details are typically associated with clinical validation studies for AI/algorithm-driven devices, which this ECG monitoring device, as described, is not.

The document primarily focuses on demonstrating equivalence to a predicate device through physical and technical characteristics, as well as adherence to various safety and performance standards.

Here's a summary of the information that is present, organized as per your request where applicable, noting the absence of the requested details related to performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are provided in the document. The performance evaluation focuses on compliance with recognized medical device standards rather than algorithm-specific performance metrics.

2. Sample size used for the test set and the data provenance

Not applicable. The document does not describe a clinical performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical performance study with expert-established ground truth is described.

4. Adjudication method for the test set

Not applicable. No clinical performance study involving adjudication of a test set is described.

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 study was mentioned. The device's ECG data is intended for manual interpretation by healthcare professionals, and the device itself does not provide automated analysis.

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

No standalone algorithm performance study was mentioned. The device's ECG signal is "not intended for automated analysis" but for "manual interpretation."

7. The type of ground truth used

Not applicable. The document does not describe a performance study requiring ground truth for an algorithm.

8. The sample size for the training set

Not applicable. The device does not employ an AI algorithm requiring a training set, according to the provided text.

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

Not applicable. No training set is mentioned for an AI algorithm.

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