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The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel

The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor.

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Pressure Control Unit PCU-2000" and an "Indications for Use Statement" attachment.

This document describes a medical device (transducer signal amplifier and conditioner) and its intended use, rather than an AI/algorithm-driven device that would undergo significant performance evaluation with acceptance criteria, ground truth, and studies like MRMC or standalone performance.

Therefore, the requested information about acceptance criteria and studies (including sample sizes, ground truth establishment, expert involvement, adjudication methods, and AI-specific studies) cannot be extracted from this document because:

• The device is a hardware component: The PCU-2000 is described as a "two-channel electrically isolated amplifier" intended to provide an "electrical interface" between a pressure transducer and a data acquisition module or medical monitor. It conditions analog signals, not processes complex image or sensor data with AI.
• The 510(k) clearance process for this type of device focuses on substantial equivalence: The letter confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This is different from the extensive performance validation required for AI/ML devices.
• No mention of AI, algorithms, or complex data analysis: The entire document refers to basic signal amplification and conditioning for physiological pressure measurements. There is no indication of any AI component, predictive modeling, or diagnostic algorithms that would necessitate the type of detailed performance studies you're asking about.

In summary, the provided text does not contain the information requested because the device described is not an AI/algorithm-driven device that would typically undergo such studies and evaluations.

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