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

Elcam Vital Signs Wireless System utilizes the Bluetooth® communications Protocol in order to eliminate the multi-conductor, fixed length and shielded reusable cables that typically acts as the interface between the patient's bedside monitor and disposable transducer. The disposable transducer will simply plugs into the system's remote transmitter unit, which sends its output signal to the system's receiver unit affixed to the bedside monitor.

The wireless system is intended to operate at varying distances to accommodate typical layouts that exist within hospital operating rooms, critical care units, emergency rooms and catheterization lab suites.

Here's an analysis of the provided text regarding the Elcam Vital Signs Wireless System's acceptance criteria and studies:

Assessment of the Provided Information:

The document is a 510(k) summary for a medical device (Elcam Vital Signs Wireless System). 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than undergoing extensive de novo clinical trials with established acceptance criteria and detailed performance metrics.

Therefore, much of the requested information (like specific acceptance criteria, detailed study designs, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance with explicit metrics like sensitivity/specificity, or training set ground truth details) is not typically found in a 510(k) summary focused on substantial equivalence.

The document does mention "performance results provided (including test results and clinical data)" but does not provide the specifics of these results or the acceptance criteria for those tests. It highlights a reliance on the equivalence to the predicate device (Hospira. Vital Signs Wireless Monitoring System - K090610).

Based on the provided text, here's what can be extracted and what is missing or explicitly not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, explicit, quantified acceptance criteria and specific numerical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the device's clinical operation are not detailed in this summary. Instead, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device, especially in design, materials, components, intended use, and labeling. The core "performance" reported is its ability to perform wireless transmission of pressure information, similar to existing methods.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a sample size for any clinical or performance test set with explicit metrics.
• Data Provenance: The document mentions "performance results provided (including test results and clinical data)" but does not detail the provenance (e.g., country of origin, retrospective/prospective nature) of this data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not provided in the 510(k) summary. For devices relying on substantial equivalence, ground truth is often established by adherence to existing engineering standards, bench testing, and comparisons to the predicate device's established performance, rather than a reader study with expert adjudication.

4. Adjudication Method for the Test Set

This information is not provided as there is no described reader study or expert-adjudicated test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC study was not described. This device is a wireless transmission system for physiological signals, not an AI-assisted diagnostic or interpretive tool that would involve human readers and AI assistance. Therefore, this question is not applicable to the Elcam Vital Signs Wireless System described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The document implies that performance testing was done on the device's ability to transmit signals, which would be a form of "standalone" functional testing. However, specific details of such standalone performance (e.g., latency, signal integrity, transmission range, battery life in various scenarios, and their acceptance criteria) are not provided in this summary. The focus is on demonstrating its functional equivalence to a wired system and the predicate wireless system.

7. The Type of Ground Truth Used

• The implicit "ground truth" for this substantial equivalence submission appears to be the established performance and safety of the predicate device (Hospira Vital Signs Wireless Monitoring System - K090610), along with adherence to relevant engineering and performance standards for wireless communication and medical devices (which would be detailed in other sections of the full 510(k) submission, not this summary). Bench testing results and clinical data were stated to be provided, implying functional validation against expected outputs from transducers and acceptable display on monitors.

8. The Sample Size for the Training Set

• This information is not applicable as the described device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware device utilizing a communication protocol.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there is no "training set" for this type of device.

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