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ECScope 200 portable, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 200 will acquire and record 12 ECG leads simultaneously.

The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.

Interpretation results must be overviewed and approved by trained physicians. Interpretation just represents partial qualitative and quantitative information of the general patient cardiovascular conditions. No therapy or drugs can be administered based solely on the interpretation statements.

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.

ECScope 200 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.

ECScope 200 is a multi channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads i.e L1, L2, L3, aVR, aVF, V1, V2, V3, V4, V5 & V6, featuring alphanumeric display and keyboard. This product has an option to print ECG data through inbuilt 2 inch thermal printer or through external USB printer. The ECG data can also be transferred in image format to USB Key or to the computer through USB Cable.

ECScope 200 can record and store in its database up to 30 ECGs. Each ECG record includes patient data, doctor's information and ECG measurements. Stored ECG can be printed directly on inbuilt Thermal Printer or through external USB printer.

ECScope 200 has optional ECG interpretative software which gives statements and measurements that represents partial qualitative and quantitative information of the patient's general cardiovascular conditions.

Interpretation program Hanover ECG System (HES) providing the following additional information:

• Representatives templates of each lead including markers on fiducial points .
• . Summary of mean measurements
• Summary of measurements performed on each lead .
• Rhythm Analysis Statements .
• . Rhythm Graphical Statements
• t Signal noise detection and information
• . Specific findings on QRS complex
• Conduction statements .
• . QRS T Diagnostic statements
• Summary of measurement performed on each lead .

The provided 510(k) summary for the DyAnsys ECScope 200 (K091397) focuses on safety and performance testing against regulatory standards, particularly ANSI/AAMI EC11:1991 Guidance Document. However, it does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria, particularly concerning the performance of the optional ECG interpretative software.

Here's a breakdown of the information available and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The submission states that "The ECScope 200 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." However, specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the ECG interpretation software or the device's ability to diagnose cardiovascular complications are not detailed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. There is no mention of a specific test set, its size, or the country of origin of any data used for evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. There is no mention of experts involved in establishing ground truth for any test data.

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The document explicitly states that the "interpretation program Hanover ECG System (HES) providing...partial qualitative and quantitative information" and "These are not intended for any specific clinical diagnosis and No therapy or drugs can be administered based solely on the interpretation statements." It also emphasizes that "Interpretation results must be overviewed and approved by trained physicians." This suggests the AI is an assistive tool, but no study on its effectiveness in improving human performance is detailed.

6. Standalone (Algorithm Only) Performance

While the document describes the "optional ECG interpretative software," it does not provide any specific standalone performance metrics for this algorithm (e.g., sensitivity, specificity, accuracy against a recognized ground truth). The statement "Interpretation just represents partial qualitative and quantitative information of the general patient cardiovascular conditions" and the requirement for physician approval indicate that the algorithm is not intended for standalone diagnostic use.

7. Type of Ground Truth Used

This information is not provided in the document. Without details on a specific test set or clinical study, the type of ground truth used (e.g., expert consensus, pathology, outcomes data) cannot be determined.

8. Sample Size for the Training Set

This information is not provided in the document. There is no mention of a training set or its size for the ECG interpretative software.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document.

In summary, the 510(k) summary for the DyAnsys ECScope 200 (K091397) primarily addresses the device's technical specifications, intended use, and its substantial equivalence to predicate devices based on safety and performance tests against regulatory standards like ANSI/AAMI EC11:1991. It provides very little detail about the analytical validation of its optional interpretative software's accuracy or clinical performance metrics as would be expected for an AI-based diagnostic tool. The emphasis is on the device's ability to acquire, display, and record ECG signals, with the interpretative software positioned as a supportive tool for physicians, not a standalone diagnostic.

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