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The Wireless Physiologic Monitoring System is indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

The Edwards Lifesciences' Wireless Physiologic Monitoring System replaces the existing cabling between disposable blood pressure transducers and bedside monitors in hospital settings. The wireless link allows the system to support all transducer performance requirements and specifications currently supported with a direct cable connection. Existing system cabling connectors are retained in the event that all available channels are filled, or in the unlikely event that issues are found in particular situations that preclude the use of the wireless connection. The Wireless Physiologic Monitoring System utilizes two types of wireless technology to provide a convenient solution for replacing cabling between the disposable pressure transducer and the patient monitor. Radio Frequency Identification (RFID) is utilized as a convenient method to initially setup the system, and the Wireless Medical Telemetry Service band (WMTS) is used for the continuous transmission of data from the transducers to the monitor during normal operation.

The provided text does not contain detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or the methodology typically associated with such studies (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI devices).

The document is a 510(k) summary for the Edwards Lifesciences' Wireless Physiologic Monitoring System. It states that the device has undergone functional and safety testing and has been shown to be "substantially equivalent" to predicate devices. This type of regulatory submission focuses on demonstrating equivalency rather than proving performance against specific acceptance criteria in the way a clinical trial for a novel device or an AI-powered diagnostic might.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document generally states that "The wireless link allows the system to support all transducer performance requirements and specifications currently supported with a direct cable connection." However, it does not provide a table detailing those performance requirements or specific numerical results from testing. It refers to "Functional/Safety Testing" but gives no specifics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. The document does not mention any specific test set sample sizes or data provenance for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. This type of information is not relevant or reported for this device, which performs wireless transmission of physiological data rather than a diagnostic interpretation requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. Not applicable given the nature of the device and information provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing. This is an AI-specific study type, and this device is a wireless physiological monitoring system, not an AI diagnostic tool. Therefore, an MRMC study is not relevant and not reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing. This is typically discussed in the context of AI algorithms. The device performs data transmission, and its "standalone performance" would relate to its ability to accurately transmit data, which is vaguely referred to as supporting "all transducer performance requirements." No specific standalone performance study details are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Missing. The concept of "ground truth" as typically defined for diagnostic or AI devices is not applicable to this wireless data transmission system. Its performance evaluation would likely involve comparing wirelessly transmitted data to directly cabled data, with the direct cable connection serving as a de-facto "truth" for accurate signal transmission. However, no specifics are given.

8. The sample size for the training set

Missing. As this is not an AI/machine learning device, there's no concept of a "training set."

9. How the ground truth for the training set was established

Missing. Not applicable.

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