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The Wireless Monitoring System is intended for use by health care professionals for routine surveillance of patient physiological parameters to include, pulse rate, respiratory rate and axillary temperature, in a hospital setting. Data is transmitted wirelessly to a central location. Notifications can be prospectively set to notify healthcare professionals to excursions outside of selected parameters.

The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older.

The proposed device consists of a patient patch with integrated temperature sensor, an electronic bridge and server software. The patch is attached to the patient and connected to existing monitoring leads to capture heart rate, respiration and body temperature. This data is wirelessly transmitted to a bridge. Multiple bridges can be installed in a hospital setting to capture signals in case the patient is moved or becomes ambulatory. Data from the patch is transmitted through a hard-wire connection to the nurses' station for surveillance. The healthcare practitioner can set limits on the patient data which in turn may trigger an alert.

Here's a breakdown of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on non-clinical performance and equivalence to predicate devices, rather than explicit acceptance criteria with specific thresholds for accuracy or sensitivity/specificity typical of clinical performance studies for diagnostic devices. However, the comparative information table provides implicit acceptance criteria by stating "Same or similar" to the predicate devices for key physiological parameters.

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

• Test Set Sample Size:
  • Usability Testing: The summary does not specify the exact number of participants for the usability testing. It mentions "participants" in the context of user opinions.
  • Wireless Testing: The summary does not provide a specific sample size (e.g., number of patients, devices, or test points) for the wireless testing.
• Data Provenance:
  • Usability Testing: Conducted at "The University of Texas at Arlington."
  • Wireless Testing: Conducted at "Palomar Pomerado Hospital."
  • The studies appear to be prospective as they are described as "testing" of the new device's operation and usability.

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

• Usability Testing: "Staff opinions were positive with participants showing an interest in using the proposed device." No specific number of experts or their qualifications for establishing a "ground truth" on usability are provided, as usability is often assessed through user feedback rather than expert ground truth.
• Wireless Testing: "Testing for EMI and other parameters were monitored and recorded." No specific number of experts or their qualifications for interpreting these technical results are provided. The "ground truth" here is the measurement data itself against predefined technical standards.

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1, 3+1) is mentioned for either the usability or wireless performance testing. The reported results are summaries of observations and measurements.

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 MRMC study was done. This device is a physiological monitoring system, not an AI-assisted diagnostic imaging device that typically uses human readers. The clinical studies focused on usability and wireless functionality, not on improving human reader performance.

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

• This device is not an algorithm-only device. It is a hardware system that collects and transmits physiological data for healthcare professionals to monitor. The "standalone" performance in this context would refer to its technical accuracy and reliable data transmission, which were broadly addressed by technical testing and wireless performance checks, not an AI algorithm.

7. The Type of Ground Truth Used

• Non-Clinical (Technical/Performance) Tests: The ground truth for these tests would be the established performance standards (e.g., IEC, ISO, FCC) against which the device's technical specifications and measurements were compared.
• Usability Testing: The "ground truth" was subjective user feedback and observation of the system's operation as intended.
• Wireless Testing: The "ground truth" was direct measurement of wireless transmission parameters and observation of interference, compared against expected operational norms.
• No pathology or outcomes data was used as ground truth because this device is for surveillance of physiological parameters, not for diagnosis based on pathology or for evaluating clinical outcomes directly tied to a specific diagnostic accuracy.

8. The Sample Size for the Training Set

• Not applicable. The device described is a hardware and software system for physiological monitoring, not a machine learning or AI model that requires a "training set" in the conventional sense. The development likely involved engineering design, testing, and refinement, but not machine learning training on a dataset.

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

• Not applicable. As stated above, there is no mention of a "training set" for machine learning algorithms in this 510(k) summary.

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

The Hospira Vital Signs Wireless Monitoring System utilizes the Bluetooth® communications protocol. It will eliminate the multi-conductor, fixed length, shielded, reusable cable that typically acts as the interface between the patient's bedside monitor and the disposable transducer. The disposable transducer will simply plug into the system's remote transmitter unit, which will send its output signal to the system's receiver unit that is 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.

The provided document, a 510(k) Summary for the Hospira Vital Signs Wireless Monitoring System, does not contain the specific information required to complete the detailed description of acceptance criteria and a study proving the device meets those criteria.

This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It outlines the device's technical characteristics, intended use, and similarities to previously cleared devices. It states that "The proposed modifications do not raise new issues of safety and/or effectiveness. Hospira Vital Signs Wireless Monitoring System meets the functional claims and intended use as described in product labeling and is as safe and effective in terms of substantial equivalence as the predicate devices described in the submission." However, it does not provide a table of acceptance criteria, specific reported device performance data against those criteria, or a detailed study plan/results.

Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text. The document asserts that the device meets functional claims, but those claims and the methods used to verify them are not elaborated upon here.

If a different document, such as a test report or a more detailed technical review, were available, it would likely contain the requested information.

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