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The VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data as well as pacemaker pulses during the events of the patient's daily activity.

The VX3 is a lightweight, compact, digital Holter recorder designed for the recording of ECG data collected from ambulatory patients. A derivative of the Datrix DR512 digital Holter recorder, the VX3 has enhanced features, including an LCD to verify leadwire hookup and display recorder status and error messages, optional keypad for selection of various options, and optional pacemaker pulse detection. Various channel and lead configurations are accommodated by using the appropriate leadwire set without additional recorder reconfiguration. Data are recorded on industry standard compact flashcards for subsequent download and to a Holter playback system. Sampling rates are factory programmable to accommodate compatibility with various OEM Holter playback systems.

The provided document is a 510(k) Premarket Notification Summary for the Datrix VX3 Series Digital Holter Recorder. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new performance study with detailed acceptance criteria and expert reviews of an AI/algorithm-based device.

Therefore, the document does not contain the information requested in the prompt, such as detailed acceptance criteria for an AI device, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or details about the training set for an algorithm.

The document primarily focuses on:

• Device Description: The VX3 is a digital Holter recorder for ECG data collection from ambulatory patients, with features like an LCD, optional keypad, and optional pacemaker pulse detection.
• Intended Use: Recording ECG data and pacemaker pulses for physician review after processing by a Holter playback system.
• Predicate Device Comparison: A table comparing the Datrix VX3 to the Datrix DR512 and Braemar DXP1000 across functional, physical, environmental, and electrical specifications. This comparison is used to establish substantial equivalence, meaning the safety and effectiveness of the new device are similar to legally marketed devices.

Conclusion: The provided text describes a medical device's technical specifications and its comparison to predicate devices for regulatory clearance, but it does not detail acceptance criteria or a study proving device performance in the context of an AI/algorithm-based system as requested.

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