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Use of the MultiView WorkStation Infinity Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• Heart rate
• ECG Arrhythmia Analysis
• Arterial oxygen saturation
• Pulse rate
• ST segment analysis

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls.

The provided document is incomplete and only describes a 510(k) submission for a device modification, but it does not contain the actual study or acceptance criteria. The information provided here focuses on the administrative aspects of a 510(k) application, such as the device's trade name, common name, classification, and intended use. It also mentions that the modification enables "Pause, Bradycardia, and Tachycardia Arrhythmia calls."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text.

To answer your request, I would need a document specifically detailing the verification and validation (V&V) testing performed for the device modification, which would include:

• Acceptance Criteria: Specific thresholds or performance metrics that the device must meet.
• Study Design: How the test was conducted.
• Device Performance: The results observed during the study.
• Sample Size and Data Provenance: Details about the dataset used.
• Ground Truth: How the reference standard was established.
• Expert Details: Qualifications and number of experts involved.
• Adjudication Method: If applicable.
• MRMC or Standalone Studies: If such studies were performed.
• Training Set Details: If applicable for an AI/algorithm.

Without this information, I cannot complete the table or answer the specific questions about the study.

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