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Use of the MultiView (SC3000) Workstation Infinity Telemetry System is indicated for adult and pediatic patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician) when the professional determines that a device is required on moussional produce visual and audible alarms for any one or more of the following parameters:

• Heart rate .
• ECG arrhythmia analysis .
• . ECG ST segment elevation or depression
• Pulse rate .
• Arterial oxygen saturation.

The Siemens MultiView Workstation consists of a PC workstation, up to two CRT displays, keyboard, mouse/trackball input devices and a laser printer.

The Infinity Telemetry System Enhancement adds a CPU/receiver that communicates with the MultiView Workstation PC, an antenna system, a transmitter programming port, radio frequency transmitters and a strip chart recorder. The CPU/receiver can be configured for 1 - 4, 1 - 12, and 1 - 16 receiver channels for the monitoring of 1 - 16 transmitters.

The Siemens MultiView Workstation Infinity Telemetry System is intended to monitor adult and pediatric patients in a healthcare setting under the supervision of professionals. The device provides visual and audible alarms for heart rate, ECG arrhythmia analysis, ECG ST segment elevation or depression, pulse rate, and arterial oxygen saturation.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

Acceptance Criteria and Device Performance

The submission indicates that the MultiView Workstation with Infinity Telemetry Enhancement improves upon the predicate device (Siemens 1481 T Digital Telemetry system) in several aspects that can be interpreted as demonstrating meeting enhanced performance criteria.

Specifics on the Study

The provided document does not contain detailed information about specific studies that rigorously prove the device meets explicit acceptance criteria in a quantitative manner (e.g., sensitivity, specificity for arrhythmia detection). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and outlining improvements in various features and specifications.

Based on the available information:

2. Sample size used for the test set and data provenance: Not explicitly stated. The submission refers to "validation results" and "clinical performance data for equivalence" in Exhibit Q, but details about the sample size, its composition, or provenance (country of origin, retrospective/prospective) are not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not explicitly stated.
4. Adjudication method for the test set: Not explicitly stated.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not indicated. The submission focuses on device features and comparison to a predicate, not on human reader performance with or without AI assistance.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not explicitly detailed. While the device performs automated functions like arrhythmia detection and heart rate measurement, the submission does not present standalone performance data (e.g., sensitivity/specificity for these functions) from a dedicated study. The improvements mentioned (e.g., HR accuracy, enhanced ECG performance for pediatric use) imply internal testing or validation but without specifics.
7. Type of ground truth used: Not explicitly stated in this summary. For parameters like heart rate accuracy or arrhythmia detection, the ground truth would typically be established by expert review of ECG recordings or comparison to a gold standard measurement device.
8. Sample size for the training set: Not applicable, as this device primarily relies on established physiological monitoring principles and hardware/software improvements rather than a machine learning model that would require a distinct training set in the modern sense.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is available:

The submission focuses on establishing substantial equivalence to a predicate device (Siemens 1481 T Digital Telemetry system) by highlighting similarities and demonstrating enhancements. The "Explanation of the differences" section implies that these enhancements lead to improved performance, such as:

• Improved ECG performance allowing pediatric use: This suggests that the device's ECG processing capabilities were validated to be suitable for pediatric patients, who have different heart rates and ECG characteristics than adults.
• Increased number of events stored: A practical improvement for clinicians.
• Added ECG leads: Provides more comprehensive diagnostic information.
• Extended HR range and improved HR accuracy: Directly addresses a performance metric by offering a wider measurement range and better accuracy.
• Sophisticated modulation technique: Implies improved signal integrity and reduced channel spacing, contributing to overall reliability.
• Enhanced shock resistance: A physical durability improvement compliant with EN 60601-2-27.

The document states, "The comparison of intended use and technological features of these devices to other legally marketed devices taken together with the validation results and other information in this submission indicate that these devices are substantially equivalent to legally marketed predicated devices in safety, effectiveness and intended use."

The "Assessment of non-clinical performance data for equivalence" (Exhibit J) and "Assessment of clinical performance data for equivalence" (Exhibit Q) are referenced but not detailed in the provided summary. These exhibits would ostensibly contain the specific studies and data used to support the claims of equivalence and improved performance.

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