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Portable ECScope 12i hand held, battery operated 12 channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope 12i will acquire, record 12 ECG leads simultaneously and display 3 leads in its display unit.

Portable ECScope 12i 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 a specific clinical diagnosis. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.

Portable ECScope 12i is designed to acquire, display and record ECG signals from surface electrodes. The device consists of two basic components: the processing unit and the patient acquisition module.

Portable ECScope 12i is a multi channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads i.e L1, L2, L3, aVR, aVL, Avf, V1, V2, V3, V4, V5 & V6, 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 12i can record and store in its Database up to 34 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed and printed on the external printer using a PC.

The portable ECScope 12i is designed to acquire, display, and record ECG signals. The device was subjected to safety and performance tests against regulatory standards, and final testing included various performance tests as per ANSI/AAMI EC11:1991 Guidance Document.

No specific acceptance criteria or reported device performance metrics were provided in the document. The study's purpose was to demonstrate substantial equivalence to predicate devices, not to establish new performance metrics against predefined acceptance criteria. Thus, a table of acceptance criteria and reported device performance cannot be generated from the provided text.

The document does not describe the specific study that proves the device meets acceptance criteria, beyond stating that "Final testing for the product included various performance tests as per ANSI/AAMI EC11:1991 Guidance Document." There is no detailed information on:

1. Sample size for the test set and data provenance: Not mentioned.
2. Number of experts used to establish ground truth and their qualifications: Not mentioned.
3. Adjudication method for the test set: Not mentioned.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
5. Standalone (algorithm only) performance: Not mentioned, as this device appears to be a hardware ECG acquisition unit.
6. Type of ground truth used: Not mentioned.
7. Sample size for the training set: Not mentioned. This is a hardware device, and the focus of the submission is on physical performance and substantial equivalence rather than AI/algorithm training.
8. How ground truth for the training set was established: Not mentioned.

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