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The Universal Physiological Measurement Module is intended for use on patients requiring Rwave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT.

The UPMM is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.

Universal Physiological Measurement Module (UPMM)

This document is a 510(k) clearance letter from the FDA for a device called "Universal Physiological Measurement Module (UPMM)". It is not a study report or clinical trial documentation. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document states that the FDA reviewed a "Section 510(k) premarket notification" and determined the device is substantially equivalent to legally marketed predicate devices. This means the device met the regulatory requirements for 510(k) clearance at the time, which typically involves demonstrating that the new device is as safe and effective as an already legally marketed device. However, the clearance letter itself does not provide:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets, data provenance, number of experts, or adjudication methods for any studies.
• Information on comparative effectiveness studies (MRMC) or standalone performance studies.
• Information on ground truth establishment for test or training sets, nor the sample size of any training sets.

In summary, based on the provided text, it is not possible to answer your questions as the document is an FDA clearance letter, not a scientific study report.

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