(14 days)
The Galaxy 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 (Lead I / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2), Capnography (CO2) & Anesthesia agents. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, EtAA and FiAA 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 Galaxy unit is a multiparameter Patient monitor System with an external 14 inch RGB compatible VGA monitor (640X480 pixels). The parameters provided are ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Invasive BP and Anesthesia gas monitoring (AGM). AGM provides CO2, N2O and 5 anesthesia agents.
Galaxy is a four channel monitor with waveform display capability for ECG (Lead I / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2), Capnography (CO2) & Anesthesia agents. It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, EtAA and FiAA readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters and for NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. Galaxy has got an optional Thermal recorder for printing Tabular trends & waveforms.
The provided document is a 510(k) summary for the "GALAXY" Patient Monitoring System by Larsen & Toubro Limited. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics of a novel algorithm or AI.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment (especially for AI or algorithmic performance evaluation) is not available in this document.
The document discusses the device's technological characteristics and its comparison to predicate devices, stating that "The no. of channels, range and accuracy of the parameters & method of sensing are similar to this predicate device -- Star 50." This implies that the acceptance criteria for the GALAXY system's performance are largely aligned with the established performance of its predicate devices, but the specific numerical criteria and detailed results of a study to prove these are not explicitly presented.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria (Implied / Not Explicitly Stated Numerically) | Reported Device Performance (Implied / Not Explicitly Stated Numerically) |
|---|---|---|
| ECG | Similar to predicate device STAR 50 (channels, range, accuracy) | "similar to this predicate device -- Star 50." |
| Respiration | Similar to predicate device STAR 50 (channels, range, accuracy) | "similar to this predicate device -- Star 50." |
| Temperature | Similar to predicate device STAR 50 (channels, range, accuracy) | "similar to this predicate device -- Star 50." |
| NIBP | Similar to predicate device STAR 50 (channels, range, accuracy) | "similar to this predicate device -- Star 50." |
| Pulse Oximetry | Similar to predicate device STAR 50 (channels, range, accuracy) | "similar to this predicate device -- Star 50." |
| Invasive BP | Similar to predicate device STAR 50 (channels, range, accuracy) | "similar to this predicate device -- Star 50." |
| Anesthesia Gas Monitoring | Similar to predicate device Vamos Anesthetic Gas Monitor | "available with Larsen & Toubro Limited make GALAXY Patient monitor." |
| Audible & Visual Alarms | Similar to predicate device STAR 50 | "similar to those in the Predicate device - Star 50" |
| Compliance to Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, AAMI EC 13, IEC 60601-2-30, AAMI SP10 | The device "complies" or "is referred" to these standards (not explicitly stated as meeting them in the summary, but implied for substantial equivalence). |
Note: The document only implies acceptance based on similarity to predicate devices and compliance with standards. It does not provide specific numerical ranges, accuracy percentages, or other direct performance measurements for acceptance criteria or reported performance for the GALAXY system itself.
2. Sample size used for the test set and the data provenance:
- Not available. The document does not describe a clinical study with a test set of patient data. The evaluation appears to be based on engineering and system comparisons to predicate devices for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. No mention of experts or ground truth establishment for a test set in the context of performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No test set or adjudication process is 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:
- No. This document describes a patient monitoring system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a patient monitoring system which inherently involves human interpretation of monitored data by a healthcare provider. There is no mention of a standalone algorithm performance test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not available. The document focuses on the technical characteristics and functionality of the device in comparison to predicate devices, rather than a diagnostic performance where a "ground truth" (e.g., pathology) is typically established. The implied "ground truth" for showing equivalence would be the established performance and safety of the predicate devices and compliance with relevant medical device standards.
8. The sample size for the training set:
- Not applicable/Not available. This document does not describe a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not available. As above, no training set is mentioned as there's no AI/ML algorithm being evaluated in this context.
§ 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).