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The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions.

The DS20 also measures the following patient vital information to further assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight.

The DS20 is intended for data collection only. It is not intended for continuous momitoring use and does not provide an alarm function.

The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.

The Diagnostic Station DS20 is a 12-lead EGG (Electrocardiograph) device used for the recording, analysis and evaluation of ECG waveforms. It also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO>), carboxyhemoglobin saturation (SpCO), respiration, temperature and weight. It also supports a 5-lead ECG measurement of heart rate when 12-lead ECG analysis is not needed.

The DS20 does not provide a patient monitoring capability with alarm annunciation.

The DS20 has a color display. It accepts user input via a touch panel, barcode scanner or keyboard. It can generate a variety of reports that can be viewed on the display or printed on a strip chart recorder or laser printer.

The DS20 is mains- or battery-powered and uses sensors that come in contact with the patient.

The DS20 is intended to function in the patient vicinity alongside other medical devices. It can operate as a stand-alone device or can be connected to the SCHILLER SEMA3 Data Management System via Ethernet (land-line or WiFi) in order to store reports and retrieve work orders for a given patient.

This document describes the Diagnostic Station DS20, a medical device for recording and analyzing ECG waveforms, along with other vital signs. The provided text outlines the device's indications for use and performance data, but it does not contain specific acceptance criteria, detailed study designs for clinical performance, or a comparative effectiveness study with human readers.

Based on the provided text, here's a breakdown of the information requested, with "N/A" indicating information not explicitly found:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on compliance with established regulatory standards for electrical safety, essential performance, and electromagnetic compatibility (EMC), as well as software verification and validation. It does not provide numerical acceptance criteria for specific diagnostic performance metrics (e.g., sensitivity, specificity for ECG interpretation) nor does it report those metrics.

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

• Sample Size for Test Set: N/A (The document primarily details compliance with regulatory standards through successful testing, not a specific clinical test set for diagnostic performance.)
• Data Provenance (e.g., country of origin, retrospective/prospective): N/A (Clinical study data for performance evaluation is not detailed in this submission summary.)

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

• N/A (The document does not describe a test set with expert-established ground truth for diagnostic performance.)

4. Adjudication Method for the Test Set

• N/A (No specific test set or adjudication method is described.)

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

• Was it done? No. The document does not mention any MRMC comparative effectiveness study or any studies involving human readers, with or without AI assistance.
• Effect size of human reader improvement: N/A (Not applicable as no such study was performed/reported.)

6. Standalone (Algorithm Only) Performance Study

• The Diagnostic Station DS20 is described as a device that records, analyzes, and evaluates ECG waveforms and measures vital information. It supports a 5-lead ECG measurement of heart rate. The document mentions "analysis and evaluation of ECG waveforms" which implies an algorithmic component. However, it does not describe a standalone performance study comparing its algorithmic output against ground truth for specific diagnostic accuracy metrics (e.g., automated ECG interpretation accuracy). The performance data section focuses on general safety, performance, and software standards compliance rather than diagnostic performance of its analytical features.

7. Type of Ground Truth Used

• N/A (For the aspects related to diagnostic performance of ECG interpretation or vital signs analysis, specific ground truth methods are not detailed. The "successful testing" refers to compliance with performance standards rather than clinical accuracy against a gold standard.)

8. Sample Size for the Training Set

• N/A (The document does not provide information about a training set for any algorithmic components within the device.)

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

• N/A (No training set is mentioned in the provided text.)

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