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The IMPACT.wf Mobile Waveform Receiving System is intended for the secondary annunciation and display of selected alarm conditions at remote locations throughout a defined area of coverage. The device is intended for use within the hospital/facility environment. The intended patient population is the same as the device generating the information used by the IMPACT.wf. The IMPACT.wf is not intended to replace primary monitoring via the central station, telemetry system, or patient bedside monitor.

The IMPACT.wf provides a secondary means for displaying and annunciating patient monitoring system alarm conditions at remote locations throughout a defined area of coverage in a hospital. The IMPACT.wf is not intended to replace the primary monitoring via the central station, patient bedside monitor, or telemetry system.

The IMPACT.wf consists of the following basic components: the IMPACT.wf Server (PC platform); Micro Serial Server; Transmitter; and Receiver(s) (Pagers). Optional components include Workstation(s).

The IMPACT.wf Server observes the Unity™ network for alarm packets containing information about patient events that are generated by the patient monitors. When alarm packets are observed, it processes the information, and transmits the information to the caregiver worn receiver(s). Data provided includes name, bed, heart rate, arrhythmia call, an ECG waveform, and enabled monitored parameter numerics (i.e. ECG heart rate, SpO2, ST, arterial BP, NBP and ART disconnect).

The IMPACT.wf Server does not acquire physiological signals from a patient nor does it process the physiological data received from the patient monitors to determine patient status. These functions are reserved for the patient monitoring system.

The provided text describes a medical device, the IMPACT.wf Mobile Waveform Receiving System, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in a performance study section of a 510(k) submission.

The document focuses on regulatory approval based on demonstrating the new device is "as safe, as effective, and performs as well as the predicate device" through general compliance with voluntary standards and quality assurance measures, rather than specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide details on sample sizes, ground truth establishment, or specific study methodologies as these are not present in the provided text.

The text states:

• Test Summary: "The IMPACT.wf complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the IMPACT.wf: Requirements specification review, Software validation and hardware testing, Safety testing, Environmental testing, Final validation."
• Conclusion: "The results of these measurements demonstrate that IMPACT.wf is as safe, as effective, and performs as well as the predicate device."

This indicates that the "study" was primarily focused on demonstrating equivalence through adherence to quality standards and validation processes, rather than a quantitative performance study with specific acceptance criteria and a test set.

If this were a more recent and/or AI-driven device, such details would be expected. However, given the submission date (1999), the regulatory framework and expectations for device validation might have been different, emphasizing functional equivalence and adherence to established quality systems.

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