(70 days)
The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.
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I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the TranStar Intracranial Pressure Transducer, which states that the device is substantially equivalent to legally marketed predicate devices.
The letter mentions the indications for use but does not detail any performance metrics, study results, sample sizes, ground truth establishment, or expert qualifications that would be required to fulfill your request. It's a regulatory approval document, not a scientific study report.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).