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The SE-1200 Pro&SE-1201 Pro 12-lead electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiographs are only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

SE-1201 Pro&SE-1200 Pro (2 models: SE-1201 Pro and SE-1200 Pro) features a LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC.

The provided document is a 510(k) premarket notification for Electrocardiograph models SE-1200 Pro and SE-1201 Pro. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document makes a clear statement regarding clinical data: "Clinical data: Not applicable." This indicates that no clinical study was conducted to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy. Instead, the submission relies on non-clinical data, including electrical safety, electromagnetic compatibility (EMC), and performance testing (bench).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or MRMC studies, as the submission explicitly states that clinical data was not applicable.

The device's performance demonstration relies on:

1. Electrical safety and electromagnetic compatibility (EMC): Conformity to standards like ANSI AAMI ES 606601-1:2005/(R) 2012, IEC 60601-1-2:2014, and IEC 60601-2-25 Edition 2.0 2011-10.
2. Performance testing (bench): Functional and system-level testing to validate accuracy specifications and compliance with relevant consensus standards (e.g., IEC 60601-2-25).
3. Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance for software in medical devices.

The conclusion states that "The bench testing data and software verification and validation demonstrate that Electrocardiograph SE-1201 Pro&SE-1200 Pro is substantially equivalent to the predicate devices." This substantial equivalence is based on the technical and non-clinical performance characteristics, not on a clinical effectiveness study involving human subjects or interpretation.

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