(110 days)
The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatire 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 / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic and Mean), Temperature , IBP , EtCO2 and FiCO2 readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons.
Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include:
- . ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card.
- SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body.
- NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure.
- CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available
- . IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure
- . AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.
This document is an FDA 510(k) summary for the Skanray Technologies Pvt Ltd. "Star 90" patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics for an AI/algorithm-driven device.
Based on the provided text, the device is a cardiac monitor, and the studies mentioned are non-clinical (electrical and EMC testing, and performance testing against recognized standards). There is no information provided about AI or algorithms, human reader studies, or detailed performance metrics against specific acceptance criteria for a new AI function.
Therefore, many of the requested items cannot be extracted from this document.
For the information that can be extracted, here's a summary:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table for acceptance criteria specific to the device's performance (e.g., accuracy, sensitivity, specificity for an AI-driven function). Instead, it lists the standards against which the device was tested for electrical safety, EMC, and basic performance of its various modules. The "reported device performance" is summarized by the statement: "Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent 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)
Not applicable. The document describes non-clinical engineering and performance testing against standards, not clinical testing with a specific test set of patient data to evaluate an algorithm.
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. There is no mention of human experts establishing ground truth for a test set in the context of an algorithm's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no human-in-the-loop performance test 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. There is no mention of an MRMC study or AI assistance. The device is a patient monitoring system, not an AI-driven interpretive device in the context of this 510(k).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The document does not describe an algorithm's standalone performance study. The device is a hardware patient monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests mentioned, ground truth would be defined by the technical specifications and measurement precision requirements of the standards themselves (e.g., a known, precisely generated ECG signal, or a calibrated NIBP cuff pressure).
8. The sample size for the training set
Not applicable. This document does not describe the development or training of an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This document does not describe the development or training of an AI algorithm.
§ 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).