(69 days)
The PLANET 50 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned/supplied with the unit. Vital signs parameters include ECG (3 lead), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, non-invasive blood pressure ( systolic, diastolic and mean) Temperature, EtCO2 and FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
This PLANET 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3 lead), Respiration, Capnography, Temperature, NIBP and Pulse oximetry. with an optional inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
PLANET 50 is a three channel monitor with waveform display capability for ECG (3 lead), Respiration, Capnography (CO2) and Plethysmograph. It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has graded and color coded alarms It has 24 hours tabular and graphical trends for all parameters except NIBP. It has special tabular trend for NIBP to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions.
This document is a 510(k) summary for the "PLANET 50" Patient Monitoring System by Larsen & Toubro Limited. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for AI/ML devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) cannot be extracted directly from this type of regulatory submission. The document emphasizes compliance with safety standards and similarity in technological characteristics and performance ranges to predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy). Instead, it relies on the concept of substantial equivalence to predicate devices. The performance is assessed by confirming that the PLANET 50's parameters, ranges, and sensing methods are similar to those of the predicate devices.
| Parameter/Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (PLANET 50) |
|---|---|---|
| ECG | Similar to predicate devices (Eagle 3000, Model 8100) | 3-lead ECG, Waveform display capable |
| Respiration | Similar to predicate devices | Waveform display capable |
| Capnography (CO2) | Similar to predicate devices | Waveform display capable |
| Plethysmograph | Similar to predicate devices | Waveform display capable |
| HR/PR (Heart Rate/Pulse Rate) | Digital values displayed, similar range/accuracy to predicate devices | Digital values displayed, similar range/accuracy to predicate devices |
| SpO2 (Pulse Oximetry) | Digital values displayed, similar range/accuracy to predicate devices | Digital values displayed, similar range/accuracy to predicate devices |
| NIBP (Non-Invasive Blood Pressure) | Digital values for Systolic, Diastolic, Mean; similar range/accuracy to predicate devices | Digital values for Systolic, Diastolic, Mean; similar range/accuracy to predicate devices |
| Temperature | Digital values displayed, similar range/accuracy to predicate devices | Digital values displayed, similar range/accuracy to predicate devices |
| EtCO2 and FiCO2 | Digital values displayed, similar range/accuracy to predicate devices | Digital values displayed, similar range/accuracy to predicate devices |
| Alarms | Audible & visual alarms, graded and color-coded, adjustable limits, alarm recall | Graded and color-coded alarms, adjustable limits, visible and audible signals, 16 alarm recall |
| Trends | Tabular and graphical trends available (predicate specific) | 24 hours tabular and graphical trends for all parameters except NIBP; special tabular trend for NIBP (240 readings) |
| Display | TFT color display (like CSI Model 8100) | TFT color display |
| Recorder | Thermal array recorder (like Marquette Eagle 3000) | Inbuilt two-channel thermal array recorder |
| Power Source | Battery (like CSI Model 8100) | Battery (2 sealed lead acid) |
| Safety Compliance | IEC 60601-1, IEC 60601-1-2 | Complies with IEC 60601-1, IEC 60601-1-2 |
| ECG Safety Compliance | IEC 60601-2-27 | Complies with IEC 60601-2-27 |
The overarching "acceptance criterion" is that "The range and accuracy of the parameters & method of sensing are similar to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As a substantial equivalence submission, it relies on comparison to previously cleared devices rather than new clinical data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of a clinical test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a clinical test set requiring adjudication.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. The device is a patient monitoring system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a hardware patient monitoring system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of this 510(k) submission, as it focuses on demonstrating technological equivalence to predicate devices and compliance with safety standards rather than establishing a new clinical ground truth for a novel diagnostic or therapeutic algorithm.
8. The sample size for the training set
This information is not provided and is not applicable as the device is a patient monitor, not an AI/ML system that undergoes a "training" phase with data.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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).