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The MH1 MicroHolter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the following indications:

• Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
• Evaluation of patients for ST segment changes.
• Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
• Clinical and epidemiological research studies.
• Evaluation of patients with pacemakers.
• Indication of time and frequency domain heart rate variability.
• Evaluation of patient for QT interval.

The MH1 MicroHolter Recorder is a Holter recorder for ambulatory electrocardiogram (ECG) recording. The system consists of three components: a Recorder, a Base Station (computer interface) and the Base Software. The system operates like a conventional ECG monitoring system where data is recorded on Flash memory installed within the MH1 Recorder.

The MH1 MicroHolter Recorder is worn by the patient during ECG monitoring whereas the Base Station is connected to a computer.

After the recording is complete, the MH1 MicroHolter Recorder docks with the Base Station, connected to a personal computer via USB. The Flash memory is then automatically uploaded to the computer via the MH1 Base Software for basic analysis. Data can then be transferred to a Computer Analysis System for further analysis of the recorded ECG data. The MH1, MH1B Base Station and MH1 Base Software are compatible with Windows 98 or higher.

The MicroHolter Recorder system is primarily a 3 channel recorder designed to be as small and lightweight as possible, using a second hardware component, the Base Station, for data interface with a host computer and contact-less monitoring of the recorded signals for electrode placement purposes.

The recorder converts the three differential inputs into 10 bit digital values which are stored in an internal FLASH memory along with the condition of the annotate button and a parity check bit. Simultaneously, the data values are modulated onto a low frequency carrier signal which is applied to a magnetic loop antenna so that the signal may be picked up at a short distance and converted into a visible waveform on a host computer for verification of electrode lead function.

The provided document describes the Exelys MH1 MicroHolter Recorder, a device intended for ambulatory ECG recording, and details its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any statistical performance metrics typically associated with AI/algorithm-driven medical devices.

Instead, the document focuses on:

• Applicant Information: Contact details for Exelys LLC and their correspondent.
• Device Name and Classification: Proprietary and classification names, regulatory information, and product codes.
• Predicate Device: Identification of the Braemar, Inc. DL900 Series Holter Recorder (K071733) as the predicate device, emphasizing substantial equivalence in indications for use, performance, and technological characteristics.
• Device Description: Explanation of the MH1 MicroHolter Recorder's components (Recorder, Base Station, Base Software) and how it operates to record and transfer ECG data. It mentions the conversion of analog inputs to 10-bit digital values stored in internal FLASH memory and a low-frequency carrier signal for electrode placement verification.
• Intended Use/Indications for Use: A list of clinical scenarios where the device is intended to be used, such as evaluation of symptoms, therapeutic interventions, ST segment changes, patient response after activities, research studies, pacemaker evaluation, and heart rate variability/QT interval assessment.
• Summary of Technical Characteristics: Highlights the device's 3-channel recording capability, small size, lightweight design, and the use of the Base Station for data interface and contact-less signal monitoring.
• Testing: A general statement that "EXELYS LLC has conducted extensive validation testing... as a cardiovascular monitoring device that is capable of accurately recording and transmitting ECG data." It further states that all components "have been tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively."
• Safety and Effectiveness Conclusions: Concludes substantial equivalence to the predicate device and states that the MH1 MicroHolter Recorder "raises no new safety or effectiveness issues."
• FDA Communication: An FDA letter granting 510(k) clearance based on substantial equivalence to the predicate device.

Therefore, based on the provided text, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed. The document relies on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance: No test set details are provided. The "extensive validation testing" is mentioned, but without specifics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no specific test set or ground truth establishment process is described beyond general validation.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is an ECG recorder, not an AI analysis tool for human interpretation.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device records ECG data; it does not perform automated analysis that would require a "standalone" performance study in the context of an AI algorithm. Its function is data acquisition for subsequent analysis by other systems or human readers.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document serves as a 510(k) premarket notification for a medical device (an ECG recorder) using the substantial equivalence pathway. It does not describe an AI/algorithm-based device and thus does not contain the types of performance study details requested in the prompt, which are typically associated with such technologies.

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