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The EPI Mini Portable ECG Recorder ("EPI Mini") is intended for use with a patient's smartphone to record, store and wirelessly transmit physiological data to a remote server. It is indicated for individuals who are at risk for cardiac disease, experience transient symptoms suggesting possible cardiac arrhythmia or have existing heart conditions.

The device can function as an Rx product when prescribed by and used under the supervision of a physician for the purpose of monitoring a patient's ECG data. It is not a diagnostic device.

The EPI Mini is intended for use by adults who suffer from cardio-vascular disease, are considered high risk for possible cardiovascular events or are concerned about their heart function and rhythm.

The EPI Mini ECG Portable Health Monitoring System ("EPI Mini") is a portable recording device which is designed to be used in combination with an individual's smartphone to create a portable health monitoring system. Not only does the EPI Mini record and store a user's physiological data but when paired with smartphone technology is capable of wirelessly transmitting such data to a remote server for review, monitoring and interpretation by a learned intermediary, and subsequent forwarding to the user's physician when necessary.

The device can function as an Rx product when prescribed by and used under the supervision of a physician for the purpose of monitoring a patient's ECG data. It is not a diagnostic device.

The EPI Mini is a portable single-channel device composed of 3 metallic electrode sensors strategically located on 3 sides of the device. The EPI Mini measures electrical differences between two points when in direct contact with the user's skin surface and is capable of recording new Electrocardiograms or ECGs every 30 seconds.

Holding the sides of the device (the metallic sensors) with their left and right hands, the user presses the "Enter" button to begin ECG recording. It takes approximately 30-45 seconds to measure an ECG.

A recorded ECG can then be sent to the user's smartphone (i.e., a mobile or cellular telephone) using patented bluetooth technology that relies on a proprietary EPI mHealth Application or "EPI mHealth App" which can be downloaded from the user's respective App store. The App allows a user to wirelessly transmit the ECG data to a remote server for monitoring by a learned intermediary, processing, storage and when necessary, forwarding on to the user's physician for review and evaluation. From the remote server and monitoring center, the data can be delivered to a physician by mobile phone, fax, email or internet. The mHealth App also allows storage of ECGs on the user's smart phone.

The mHealth App also allows for the personal storage of a user's own physiological data such as blood pressure, blood glucose levels and cholesterol. Such stored data can be updated and retrieved for later use and also displayed in a line graph format for trend analysis. Additionally, the mHealth App permits a user to view, resend and/or delete saved data as needed.

The EPI Mini is composed of several individual components including (1) the EPI Mini portable ECG recorder, (2) a USB data cable, (3) the mHealth application which can be purchased and downloaded from the user's respective application store, and (4) a 500mAh battery.

The provided 510(k) summary for the EPI Mini ECG Portable Health Monitoring System (K121628) does not contain specific acceptance criteria or a detailed study description to prove the device meets such criteria.

The document outlines general performance testing, but lacks the quantitative metrics, methodologies, and results typically associated with a study designed to demonstrate equivalence against defined acceptance criteria.

Therefore, many of the requested sections below cannot be filled from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Bench Testing to assess data integrity during the transmission of ECG data from the EPI Mini to representative smartphone technology," but doesn't provide details on the data used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not specified. The document does not describe the establishment of ground truth for any test set.

4. Adjudication Method for the Test Set

• Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document does not mention an MRMC study or comparative effectiveness with human readers.

6. Standalone (Algorithm Only) Performance Study

• Not explicitly described as a standalone algorithm study. The testing appears to focus on the device's functional performance, data transmission, and safety standards adherence. The device is described as recording and transmitting physiological data for review, monitoring and interpretation by a learned intermediary, indicating a human-in-the-loop system rather than a standalone diagnostic algorithm.

7. Type of Ground Truth Used

• Not specified.

8. Sample Size for the Training Set

• Not applicable as the document does not describe the development or testing of an AI algorithm, or a training set for such a purpose.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

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