(88 days)
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).