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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 LifeGurney™ 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 Vigilance Display is a modification of the LifeBed Display previously submitted and cleared as K083534. The Vigilance Display differs from the Lifebed Display in that it has additional enclosures attached which contain batteries, a battery controller, an auxiliary nurse call system, and a wireless adapter. The battery and controller are attached to the Display, the auxiliary nurse call system and wireless adapter are attached to the top.

User interaction is the same as on the LifeBed Display—the front panel keypad (hidden behind a door in the above photos) is used to change settings and mark events in the log. The large button on the front of the Display is used to acknowledge events. The software for the same as in the predicate system. The nurse call connector and the Display power switch are located under a hatch on the right side of the Display (as viewed from the front). The Display power switch controls the power from the batteries to the Display.

The AC power connection is on the side of the battery and controller enclosure. Above the AC power connection is the main power switch. This switch controls the AC power to the battery controller. When the switch is on and an AC power source is connected the batteries are charging. When the switch is off or no AC power source is connected, then power is drawn from the batteries. On the opposite side are the slots for the removable batteries. These batteries are typically installed in pairs, but only one is required to operate the system (with reduced run time).

An optional external battery charger and spare batteries are available, enabling the operation of the system in areas where AC power is not available or is difficult to use.

The coverlet is the component that provides the interface between the patient and the Vigilance Display unit. It contains the sensors, wiring, and electronics necessary to measure the patient's heart rate, respiration rate, and bed presence and transmit signals to the Vigilance Display.

The LifeGurney Network Patient Vigilance System is compatible with and uses the same series of coverlets as the LifeBed Network Patient Vigilance System. Gurney specific coverlets will be sized to fit specific gurney mattresses.

The coverlet contains the sensing elements and interface electronics for connecting the coverlet to the Display with a coverlet cable. The sensing elements and electronics are separated from the patient by a layer of coated fabric; there is no contact between the patient and the sensors. Additional separation of the sensors is provided by the bed sheets, pads, and the patients' garments. The coverlet encases the existing mattress. The coverlet contains all necessary conductors to carry sensor signals within the coverlet.

The provided document is a 510(k) summary for the LifeGurney™ Network Patient Vigilance System. It describes the device and claims substantial equivalence to a predicate device (LifeBed Network Patient Vigilance System, K083534).

However, the document does not contain acceptance criteria for device performance nor a detailed study report that proves the device meets specific acceptance criteria related to its performance characteristics (heart rate, respiratory rate, bed exit detection accuracy).

Instead, it asserts substantial equivalence based on technological characteristics and functional capabilities being the same as the predicate device, and states that "All verification and validation testing conducted demonstrate that the LifeGurney Network Patient Vigilance System is substantially equivalent to the LifeBed Network Patient Vigilance System." without providing the specifics of this testing.

Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance, nor can I provide details on sample size, ground truth, expert qualifications, or MRMC studies for performance metrics.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states that performance characteristics are the "Same" as the predicate device. For example:

• "Measures heart rate and respiration rate" - No specific accuracy or precision metrics are provided.
• "Detects bed exit" - No specific sensitivity or specificity metrics are provided.
• "Notifies nurse or caregiver of change in condition (e.g., heart rate or respiration rate exceeds set limits)" - No specific latency or reliability metrics are provided.

The "Measurement Limits" define the range over which the device is expected to operate, not its performance accuracy:

• Heart rate from 35 - 200 BPM
• Respiration rate from 4 - 70 BPM

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

This information is not provided in the document. The document mentions "verification and validation testing" but does not detail the methodology, sample size, or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests regarding the performance characteristics.

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

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this document. The device is a patient vigilance system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

The document describes the "LifeGurney™ Network Patient Vigilance System" as having various functional blocks (Sensors, Signal Processing, Logic, User Interface, Data Interface) and states that "The Signal Processing block transforms the signals from the sensors into a set of three numbers; a heart rate, a respiratory rate, and a patient presence indication." and these "numbers are then used by the Logic block to detect the conditions which are being monitored". This implies an algorithm-only or standalone performance component, but no specific standalone performance study results (e.g., accuracy metrics for heart rate, respiratory rate, or bed exit detection against a gold standard) are provided. The document states "All verification and validation testing conducted demonstrate that the LifeGurney Network Patient Vigilance System is substantially equivalent to the LifeBed Network Patient Vigilance System", but the details of these tests are absent.

7. The type of ground truth used

This information is not provided in the document. Given the nature of the device (measuring heart rate, respiratory rate, and bed exit), the ground truth would likely involve simultaneous measurement with a clinical gold standard (e.g., ECG for heart rate, capnography for respiration, direct observation for bed exit), but the document does not specify this.

8. The sample size for the training set

The document does not mention a training set as it describes the device and substantial equivalence, not the development or training of its algorithms.

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

This information is not provided as a training set is not mentioned.

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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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The LifeBed Patient Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in bed, in a general care hospital environment. The system will also monitor bed exit.

The LifeBed Patient Vigilance System consists of two (2) main components: the bedside unit and the Passive Sensor Array™ (PSA™). The bedside unit houses the digital signal processing algorithms that calculate heart and respiratory rates and bed exit status (in-bed sensor) in real time and displays the data as part of the integrated graphical user interface. The bedside unit houses the alarm logic and interfaces to the existing nurse call system found in the hospital. The PSA is comprised of a mattress ticking ("coverlet" that slips over the entire mattress) that houses an array of sensors, which connect to the bedside unit via a cable with an integrated "quick disconnect" safety feature.

The LifeBed Patient Vigilance System's Passive Sensor Array (PSA) technology analyzes basic heart and respiratory physiology without direct patient contact, eliminating the use of electrodes, wires and leads. Hoana's PSA technology integrates proprietary signal processing algorithms with patented data collection devices that produce an electrical signal in response to physiological stimuli. The LifeBed Patient Vigilance System passively extracts patient measurements even through clothing, gowns or sheets.

This 510(k) submission, K082366, is a Special 510(k) for a change to the Graphical User Interface (GUI) of the LifeBed Patient Vigilance System. As such, the submission explicitly states there are "no changes to the original submission" and "no change in the fundamental scientific technology of the device" or "indications for use." Therefore, detailed device performance studies or acceptance criteria comparisons are not included, as the modification is ergonomic, not related to the underlying physiological measurement accuracy.

However, based on the information provided, we can infer some details and state where specific information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for a GUI change, detailed performance criteria (e.g., accuracy for heart rate or respiratory rate) and associated reported device performance are not provided in this document. The focus is on the human-computer interaction, not the physiological measurement accuracy.

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

This information is not provided as the submission pertains to a GUI change, not a new performance study.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided as the submission pertains to a GUI change, not a new performance study requiring expert ground truth for physiological measurements.

4. Adjudication Method

This information is not provided as the submission pertains to a GUI change, not a new performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or reported in this submission. This type of study would be relevant for evaluating human interpretation of medical images or diagnostic tests, which is not the primary function of a GUI change in a patient vigilance system.

6. Standalone Performance (Algorithm Only)

A standalone performance study was not detailed in this submission. For a GUI change, the accuracy of the underlying algorithms (heart rate, respiratory rate, bed exit) is assumed to have been established in the original 510(k) for the LifeBed system.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used, as it focuses on software ergonomics rather than clinical efficacy.

8. Sample Size for the Training Set

This information is not provided as the submission pertains to a GUI change, not a new algorithm development requiring a training set.

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

This information is not provided as the submission pertains to a GUI change, not a new algorithm development requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this Special 510(k)):

The "study" that proves the device meets the acceptance criteria in this specific Special 510(k) is the design control process itself, as stated in the Conclusion section: "summary information that results from the design control process can serve as the basis for clearing the application."

The acceptance criteria for this Special 510(k) are implicitly:

• The GUI change does not affect the intended use of the device.
• The GUI change does not alter the fundamental scientific technology of the device.
• There are no changes in the indications for use.
• There are no changes to labeling that affects the intended use.
• There are no changes in materials.
• The ergonomics of the patient-user interface (the GUI change) is appropriate.

The basis for meeting these criteria is the absence of changes to the core functionalities, indications, and technology of the device, as asserted by the manufacturer and accepted by the FDA for a Special 510(k) pathway. The "study" per se is the internal design and verification documentation demonstrating that the GUI modification is limited in scope and does not impact safety or efficacy beyond the change in user interface presentation. Electrical, Mechanical, EMC, and Biocompatibility testing (per IEC 60601-1-2 and ISO 10993) were performed on the LifeBed system generally, and likely confirmed no adverse impacts from the GUI integration, but these tests are not specific to the GUI performance itself.

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The LG TM Intelligent Medical Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in a general care hospital environment. The system will also monitor bed exit.

The [G] system consists of two main components: the Bedside Unit, and the Passive Sensor Array™ (PSA™). The Bedside Unit houses the digital signal processing algorithms ([G1 algorithms, version 1.0.0.36) that calculate heart and respiratory rates and bed exit status (in-bed sensor) in real time, and displays the data as part of the integrated graphical user interface. The Bedside Unibilary houses the alarm logic, and interfaces to the existing nurse call system found in the hospital. The PSA is comprised of a mattress ticking ("coverlet" that zips over the entire mattress) that houses an array of sensors, which connect to the Bedside Unit via a cable with an integrated "quick disconnect" safety feature.

The Hoana Medical L1 Intelligent Medical Vigilance System is intended to measure heart rate and respiratory rate in adult patients, in bed, in a general care hospital environment. The system also monitors bed exit.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a table format. Instead, it makes a general statement about the device meeting "performance requirements." However, based on the conclusion, the implied performance criteria are that the device is "safe, effective and performs as well as the predicate devices, the Escort 100/300 Series B Patient Monitor and the Hill-Rom Advanta-Bed Patient Position Monitor."

Implied Acceptance Criteria and Reported Device Performance:

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

The provided document mentions "Clinical Testing" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The testing described is focused on the device's performance against predicate devices, not on human-AI collaboration.

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

The clinical testing described appears to be a standalone performance evaluation of the device's algorithms for measuring heart rate, respiratory rate, and bed exit. The system is designed to passively extract patient information and display data, with alarm logic built into the Bedside Unit. This suggests the evaluation was of the algorithm's performance without direct human intervention in the real-time measurement process.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given the nature of measuring heart rate, respiratory rate, and bed exit, it is highly probable that the ground truth would have been established by:

• Reference medical devices/sensors: Using established, highly accurate medical monitors as a gold standard for heart rate and respiratory rate.
• Direct observation: For bed exit, direct observation or dedicated sensors not part of the study device would likely be used to confirm bed exit events.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It refers to "proprietary signal processing algorithms" but provides no details on their development or training data.

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

The document does not provide any information on how the ground truth for the training set was established.

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