(56 days)
The PLANET multiparameter 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. It can also display the digital values of HR/PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature 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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.
PLANET is a multi-parameter Patient Monitoring System (TFT color monitor) with ECG (3 lead),Temperature,NIPB, and pulse oximetry)with an optional built-in two channel thermal array recorder which can record online data (ECG waveform and plethysmograph) along with numerical values of other parameters. PLANET is a three channel monitor with waveform display capability for ECG (3 lead), cascade and plethysmograph. It also displays the digital values of heart rate, pulse rate, SpO2, non-invasive blood pressure (systolic, diastolic and mean) and temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for ECG, SpO2 and temperature. It has special tabular trend for NIPB to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions. Printout of tabular trend and ECG waveform can be obtained through an optional inkjet printer.
The provided text is a 510(k) summary for the PLANET Monitoring System, a multi-parameter patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with standards, rather than presenting a detailed study proving performance against specific acceptance criteria for AI/ML features.
Therefore, the requested information elements such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not present in the provided document. This type of information is typically required for AI/ML device submissions, which were not the focus of this 2003 submission for a traditional patient monitor.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "The range and accuracy of the parameters & method of sensing are similar to the predicate devices." It also lists compliance with several international standards. However, specific numerical acceptance criteria (e.g., accuracy +/- X% for heart rate) and reported performance values are not provided within this summary for specific vital signs parameters. The table below reflects the general claims made about similarity and compliance.
| Acceptance Criteria (Inferred/General) | Reported Device Performance |
|---|---|
| Parameters (ECG, Temp, NIBP, SpO2) available | All listed parameters are available. |
| Range of parameters similar to predicate devices | Stated as "similar to the predicate devices." |
| Accuracy of parameters similar to predicate devices | Stated as "similar to the predicate devices." |
| Method of sensing similar to predicate devices | Stated as "similar to the predicate devices." |
| Audible & visual alarms similar to predicate devices | Stated as "similar to those in the Predicate devices." |
| Compliance with IEC 60601-1 Medical Electrical safety | Testing was conducted to demonstrate safety and effectiveness to this standard. |
| Compliance with IEC 60601-1-2 EMC Compliance | Testing was conducted to demonstrate safety and effectiveness to this standard. |
| Compliance with IEC 60601-2-27 ECG safety | Testing was conducted to demonstrate safety and effectiveness to this standard. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document focuses on technological similarities and compliance with engineering standards, not on clinical performance studies with test sets.
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)
- Not applicable/Not provided. This is relevant for AI/ML performance evaluation, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is relevant for AI/ML performance evaluation, which is not described.
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
- Not applicable/Not provided. This is a traditional patient monitor without AI assistance described in the 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a traditional patient monitor without a standalone algorithm as defined for AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. Ground truth for AI/ML training/testing is not part of this submission's summary. The "ground truth" for this device would be considered the physical measurements from validated sensors/methods, and the document implies these are similar to predicate devices.
8. The sample size for the training set
- Not applicable/Not provided. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable/Not provided. There is no mention of a training set.
§ 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).