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The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals. The Portable ECScope is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for specific clinical diagnosis. The clinical significance must be determined by a physician.

Portable ECScope is a multi channel electrocardiograph for the simultaneous acquisition of the 7 ECG leads i.e L1, L2, L3, aVR, aVL, aVF and one of the chest leads (V1-6), featuring 3-lead Display Unit, alphanumeric keyboard and an option to print the ECG data using the Print Tool on A4 Sheet Paper or Direct Printing through connected printer. Portable ECScope can record and store in its Database up to 200 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed, printed on the external printer using a PC.

The provided text is a 510(k) summary for the Portable ECScope device. It details the device's description, intended use, and comparison to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in detailed performance studies for AI/algorithm-based devices.

The document states:

"The Portable ECScope was subjected to safety and performance tests against regulatory standards. Final testing for the product included various performance tests as per ANSI/AAMI EC11: 1991 Guidance Document."

This indicates that the device underwent testing according to a recognized standard for electrocardiographs, but the specific acceptance criteria, test results, and details of how those results were obtained are not included in this summary.

Therefore, I cannot provide the requested information in the table or the detailed breakdown of study parameters because the provided text does not contain this information.

If this were an AI or algorithmic device submission, the 510(k) summary would typically include a dedicated section detailing performance data, acceptance criteria, ground truth establishment, and details of the study design. This document is a more traditional medical device submission for an ECG monitor, which relies on demonstrating adherence to established performance standards for hardware and basic functionality, rather than complex algorithmic performance metrics against a clinical ground truth.

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