(148 days)
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:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Heart Rate Measurement Accuracy | (Comparable to predicate devices: Escort 100/300 Series B Patient Monitor) | "The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..." |
| Respiratory Rate Measurement Accuracy | (Comparable to predicate devices: Escort 100/300 Series B Patient Monitor) | "The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..." |
| Bed Exit Monitoring Accuracy | (Comparable to predicate devices: Hill-Rom Advanta-Bed Patient Position Monitor) | "The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..." |
| Safety | Meets electrical, mechanical, EMC (IEC 60601) and biocompatibility (ISO 10993) standards. | "Electrical, Mechanical and EMC Testing per IEC 60601 was performed and the [G1 Intelligent Medical Vigilance System passed all tests." and "Biocompatibility testing was conducted according to the requirements of ISO 10993... All test article materials passed." |
| Effectiveness | Monitors heart rate, respiratory rate, and bed exit, and provides alarms when limits are exceeded, comparable to predicate devices. | "The results of the clinical testing demonstrate that the [G1 Intelligent Medical Vigilance System meets the performance requirements." and is "safe, effective and performs as well as the predicate devices..." |
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.
§ 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).