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The M5 Recorder 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, chest pain and/or anxiety.

The M5 Recorder is intended for use by adults and all pediatric subgroups (weighing more than 10 Kg).

The M5 Recorder is a small, lightweight ambulatory electrocardiograph (ECG) recorder that records ECG continuously. The M5 records 1 or 3 channels of ECG up to 21 days. The battery duration of the M5 is dependent on the configured settings of sample rate and channel selection. The device is composed of the ECG recorder that can be utilized with a patch electrode or with a patient cable lead set using off the shelf electrodes intended for long-term monitoring. The device snaps onto the patch electrode or patient cable lead set and automatically begins recording. The recording will continue until either the M5 completes the programmed monitoring session, is removed from the Patch Electrode or patient cable, or the battery is depleted.

At the end of the recording, the device can be plugged into a PC via the M5 USB cable. The ECG recording can be transferred to a PC where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The M5 recorder acquires ECG data and does not perform any data processing or arrhythmia analysis of the ECG data. Only the M5 Recorder is part of this 510K application.

During the recording period the patient wears the M5 Recorder with the patch electrode on the upper chest near the sternum. If using the M5 Recorder with the patient cable, the patient will wear off the shelf electrodes (2 - 5) positioned on the torso. The M5 Recorder can be worn continuously up to 14 days with the same patch electrode and up to 4 days with the patient cable and same set of off the shelf electrodes.

The M5 Recorder consists of a microprocessor, measuring circuit, memory, data storage, light emitting diode (LED), and contacts to the electrode. In addition to that, the M5 Recorder contains firmware to control the collection of the ECG data and allows transfer to the processing software. The M5 Recorder has an internal Bluetooth radio that may be utilized with a host ambulatory ECG analysis system (such as the Global Instrumentation M12A application) to allow the qualified health care provider a view of the patient's ECG immediately following hook-up. The LED on the M5 Recorder will flash. This provides visual confirmation to the professional that the recorder is actively collecting data.

The M5 recorder also has a button on the recorder. The primary function of the button is to provide an event feature where the patient presses the button on the recorder when they feel a symptom. The LED will flash to provide feedback to the patient that the event marking has occurred. The button also allows for a battery status check.

The associated spare parts that are part of the M5 Recorder system are the M5 Patch Electrode, M5 Patient Cable, M5 USB Cable, and GI Wall Charger.

The M5 Recorder is an ambulatory ECG recorder. It records 1 or 3 channels of ECG for up to 21 days for the purpose of detecting transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, chest pain, and/or anxiety in adult and pediatric patients (weighing >10 kg).

Here’s a summary of the M5 Recorder's acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative clinical acceptance criteria for the M5 Recorder's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection), as the device itself does not perform arrhythmia analysis. Instead, the performance data focuses on technical compliance with established standards and usability. The acceptance criteria essentially revolves around demonstrating substantial equivalence to predicate devices and meeting relevant safety and performance standards.

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

The document states that no clinical studies were performed. The "test set" for the M5 Recorder primarily relates to usability testing and bench testing for compliance with standards.

• Usability Testing Test Set:
  • Sample Size: 64 volunteer subjects.
  • Data Provenance: Not explicitly stated regarding country of origin, but implied to be associated with Global Instrumentation LLC (Manlius, NY, USA), so likely U.S. based. The studies were prospective as they were conducted specifically for the M5 Recorder (May 7, 2019, through March 10, 2020).
• Bench Testing: No specific "sample size" of patients/data is applicable here, as these are technical performance tests on the device hardware and software.

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

• Usability Testing: The document mentions "Clinical users participated in the U5 Usability Test. The clinical user group comprised a cross section of experience in using ambulatory ECG recorders and clinical positions representative of the intended M5 Recorder user base." It does not specify a precise number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). However, the implication is that qualified healthcare professionals who would typically use such devices were involved. The ground truth here is successful interaction with the device and its components, as assessed by these clinical users and observation by Global Instrumentation LLC personnel.
• Bench Testing: For compliance with technical standards, the "ground truth" is adherence to the specifications of those standards. This is established through engineering and quality assurance processes, not by external experts adjudicating clinical outcomes.

4. Adjudication method for the test set

• Usability Testing: The text indicates that the usability testing was "implemented and overseen by Global Instrumentation LLC personnel." It states, "The testing was successful in validating the clinical and patient usability of the M5 System based on the usability goals and pass/fail criteria established in each study." This implies an internal adjudication process based on predefined criteria, rather than an expert consensus method like 2+1 or 3+1 that is common in clinical diagnostic accuracy studies.
• Bench Testing: Adjudication is internal, based on meeting the requirements of each standard.

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, an MRMC comparative effectiveness study was not done. The M5 Recorder is a data acquisition device (records ECG data) and does not perform any data processing or arrhythmia analysis. Therefore, there is no AI component in the device itself that would assist human readers, and such a study would not be applicable.

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

No, a standalone algorithm performance study was not done. The M5 Recorder is explicitly stated to "acquire ECG data and does not perform any data processing or arrhythmia analysis of the ECG data." It is a hardware recorder, not an analytical algorithm.

7. The type of ground truth used

• For biocompatibility and mechanical testing, the ground truth is adherence to the specified international and national standards (e.g., ISO 10993, IEC 60601-1).
• For software validation, the ground truth is successful execution against specified requirements, as guided by FDA's guidance for software in medical devices and IEC 62304.
• For usability testing, the ground truth was the ability to meet "usability goals and pass/fail criteria established in each study," validated by participant interaction and observation by personnel.

8. The sample size for the training set

Not applicable. The M5 Recorder is a data acquisition device and does not contain artificial intelligence or machine learning algorithms that would require a "training set."

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

Not applicable. As stated above, there is no training set for this device.

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