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The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

The LifeBed Network Patient Vigilance System ("LifeBed Network") is composed of a bedside unit (either a LifeBed Display or Vigilance Display, generically referred to as a Display), a sensor array packaged in the form of a mattress coverlet, and the LifeBed Controller. The LifeBed Displays are optionally equipped with a wireless adapter. The LifeBed Network Patient Vigilance System collects, stores, and reports patient medical and status information. Each Display is a bedside unit that collects and processes data from a sensor array on the patients' bed. It reports patient heart rate, respiratory rate, whether the patient is in bed, and any alerts. The configuration of a Display may be changed on the Display or remotely from the LifeBed Network. The Displays are connected to the LifeBed Controller via a TCP/IP network which is provided by the customer. This network may be wired (using Ethernet), or wireless (using WiFi) as required by the facility. The hub of the LifeBed Network is the LifeBed Controller'), which serves one unit (e.g., a hospital ward). From the Controller a user has access to the collected information and the ability to view and modify the configuration of connected Displays. The LifeBed Network provides an interface which may be used to integrate with a Clinical Information System (CIS). When used in this way an auxiliary adapter isolates and translates the protocols between the LifeBed Network and the CIS. This interface allows the collected data and stored configuration for the Displays. The LifeBed Network centralizes information access and configuration for a group of Displays. It DOES NOT change the manner in which alerts are communicated by the Display to the Nurse Call system of the hospital. All user access to the LifeBed Network is constrained by a security system. Each user is authenticated by a user name and password and their ability to access data is controlled by their assigned role.

This document is a 510(k) premarket notification for an update to the LifeBed Network Patient Vigilance System. The 510(k) summary explicitly states that no clinical trials were performed in support of this submission. Therefore, it does not contain information about acceptance criteria, device performance from clinical studies, sample sizes, ground truth establishment, or expert involvement as requested.

The submission focuses on software changes to the LifeBed Controller; it relies on previous testing for substantial equivalence. The document clearly states:

• "No changes were made to the LifeBed Patient Vigilance System (KO82366) which contains the algorithm and control of the patient interface. The LifeBed Network only adds the networking and data collection capabilities. No clinical trials were performed in support of this submission." (Section labeled "Clinical Testing")
• "All verification and validation testing conducted demonstrate that this release of the LifeBed Network Patient Vigilance System is substantially equivalent to the prior release (K092037)." (Conclusion)

Therefore, I cannot provide the requested information from the provided text.

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The LifeBed Network Patient Vigilance System is intended to measure heart rate, respiratory rate, and bed exit in adult patients for use by health care professionals.

The LifeBed Network Patient Vigilance System is identical to the LifeBed Patient Vigilance System described in the LifeBed Patient Vigilance System, K082366 with three exceptions. A Controller as been added which will not be in the patient vicinity, A wireless adapter has been added, and the Indications for Use have been reworded. The LifeBed Network integrates with the LifeBed Display to collect, store and report patient medical and status information. The Display can be configured from the Network or from the Display. The Network and Display are connected using TCP/IP protocols. To ease logistical considerations at the installation site, these two components are usually bridged across a wireless network using a LifeBed Wireless Adapter. The Network also provides an interface which may be used to integrate with a clinical information system (CIS). When used in this way, an adapter box isolates and translates protocols between the Network and the CIS. The Network centralizes information access and configuration for a group of Displays. It DOES NOT change the manner in which alerts are sent through the Nurse Call system of the hospital. Each Display is a bedside unit that collects and processes data from a sensor array on the patients' bed. It reports patient heart rate, respiration rate, alarm and if the patient is in bed or out of bed to the Controller. This information is NOT displayed real time and is NOT to be used as a method to monitor the patient. The hub of the Network is the LifeBed Controller which serves one unit (e.g., a hospital ward). From the Controller the user has full access to the information gathered from the unit and configuration of all of the Displays in the unit. The Controller also provides the interface used to integrate into a CIS or with a future product. All user access to the Network is constrained by a security system. There are two factors involved: the individual user's role and the specific access permissions assigned to the user. The user's role constrains the type of data the user has access to (e.g. medical, device status, etc.). By default, all users have specific access to information sourced by their organization. Permission to access data sourced by another organization is denied unless specifically allowed. The Network operates in a medical setting and must comply with relevant regulatory agency and legal requirements. As a medical product the Network must protect patient privacy. It must comply with all the requirements of the HIPAA Act.

This document, a 510(k) Summary for the LifeBed Network Patient Vigilance System, indicates that no new clinical testing was performed for this specific submission.

The device in question, the "LifeBed Network Patient Vigilance System" (K083534), is presented as an extension of a previously cleared device, the "LifeBed Patient Vigilance System" (K082366), with the main additions being networking capabilities (Controller, wireless adapter) and reworded Indications for Use.

The submission explicitly states:
"No changes were made to the LifeBed Patient Vigilance System which contains the algorithm and controls the patient interface (K082366). The LifeBed Network Patient Vigilance System only adds the networking capabilities. Therefore, no clinical trial tests were required to support this submission."

This means that the existing performance data and acceptance criteria would have come from the previous submission (K082366) or earlier versions of the core LifeBed system that measure heart rate, respiratory rate, and bed exit. However, the provided text does not include the acceptance criteria or device performance data for the core functions, nor does it describe the study that proved the device meets these criteria.

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the specific questions about the study design, sample sizes, ground truth, or expert qualifications, as no new clinical study was conducted for this particular 510(k) submission.

Summary based on the provided text:

1. Table of acceptance criteria and the reported device performance:

   • N/A. The document states no new clinical trials were required for this submission because the core patient-contacting and algorithmic components were unchanged from a previously cleared device (K082366). The acceptance criteria and performance of those core functions are not provided in this document.

2. Sample size used for the test set and the data provenance:

   • N/A. No new clinical study was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No new clinical study was conducted for this submission.

4. Adjudication method for the test set:

   • N/A. No new clinical study was conducted for this submission.

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:

   • N/A. No new clinical study was conducted for this submission. This device is described as a vigilance system reporting physiological parameters and bed exit, not an AI-assisted diagnostic tool for "human readers."

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

   • N/A. No new clinical study was conducted for this submission. Performance of the core algorithm would have been assessed in prior submissions.

7. The type of ground truth used:

   • N/A. No new clinical study was conducted for this submission.

8. The sample size for the training set:

   • N/A. No new algorithm development or training set details are provided for this submission.

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

   • N/A. No new algorithm development or training set details are provided for this submission.

Additional Information from the text:

• Device Name: LifeBed Network Patient Vigilance System
• Indication for Use: "The LifeBed Network Patient Vigilance System is intended to measure heart rate, respiratory rate, and bed exit in adult patients for use by health care professionals."
• Substantial Equivalence Claim: The device is claimed to be substantially equivalent to the LifeBed Patient Vigilance System (K082366) and the wireless capabilities are compared to Verathon BVI 9400 (K071217) and Diagnostic Ultrasound BVM6500 (K030763).
• Testing Performed: Electrical, Mechanical, and EMC testing were conducted for both patient vicinity and non-patient vicinity components. Biocompatibility testing was not conducted as no changes were made to the patient-contacting surface (Coverlet).
• Core Functionality: The core functionality (algorithm for heart rate, respiratory rate, and bed exit) is stated to be identical to the predicate device K082366.

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