Search Results

Star 65 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 with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA 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. It shall be used only by trained clinicians.

In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).

Star 65 is a multi-parameter modular patient monitoring system for continuous monitoring of the physiological parameters like ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, CO2, Cardiac Output (CO). & Anesthesia Gas Monitoring (AGM) Module (Optional). The modular parameters are IBP, CO and CO2.

Star 65 is a 8 channel monitor with 12.1" LED display with touch screen capable of displaying and monitoring ECG, Respiration, SpO2, CO2, IBP, and O2 digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic & Mean), Invasive Blood Pressure (Systolic, Diastolic & Mean), Temperature, EtCO2, FiCO2, IPI, CO, N2O, O2, EtAA, and FiAA readings.

Star 65 has 240 Hours tabular and graphical vital trend. Star 65 has a NIBP trend of last 240 readings. Star 65 has Alarm Recall facility with last 48 'Patient Alarms' details.

Star 65 has communication features like USB for Thumb drive, Printer, Bar code scanner interface, Ethernet for CNS & Bed to Bed connectivity, HDMI output for External monitor connectivity, External Port for AGM 55 interface, Wi-Fi for CNS, Bed to Bed & Network Printer connectivity. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals, high priority alarms are indicated by red colour, medium priority alarms are indicated by yellow colour & low priority alarms are represented by blue colour.

Star 65 has got Drug calculator software package to display drug dosage applied / to be applied for the standard Medicines.

The provided text describes the 510(k) premarket notification for the Skanray Technologies Pvt Ltd Star 65 patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, it is important to note that the document does not present a standalone clinical study to prove the device meets acceptance criteria. Instead, it relies on demonstrating that the subject device's performance, as measured through non-clinical (bench) testing against recognized standards, is comparable to its predicate devices, which are already legally marketed.

Here's an breakdown based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of a clinical study outcome. Instead, it details the performance specifications of the Star 65 and compares them to predicate devices. The "reported device performance" is essentially the listed specifications for the Star 65, and "acceptance criteria" can be inferred as being equivalent to or meeting the performance of the predicate devices and relevant consensus standards.

Since a strict "acceptance criteria" table from a dedicated study is not available, I will present the performance specifications of the Star 65 as its "reported performance," and the "acceptance criteria" is implied to be that these specifications are within acceptable ranges, similar to the predicate devices, and comply with the listed consensus standards.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a patient-based study. The testing performed was non-clinical (bench testing), as stated in Section VII. "NON-CLINICAL STUDY." It refers to "Electrical, mechanical environmental safety and performance testing according to the following consensus standards" and "Performance testing- Accuracy, Environment cycling, Temperature Rise Test, wireless co-existence were performed according to Design Requirement specification and Validation plans."

Therefore, there is no patient sample size for a test set described. The data provenance is from bench testing results, not human data. The document does not specify the country of origin for the testing itself, but the device manufacturer (Skanray Technologies Pvt Ltd) is based in India.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. Since no patient-based clinical test set was used, there was no ground truth establishment by experts in that context. The "ground truth" for the non-clinical performance validation was the specifications and performance outlined in the relevant consensus standards (e.g., IEC, ISO standards).

4. Adjudication method for the test set

This section is not applicable. No patient-based test set requiring expert adjudication was conducted.

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 a multi-reader multi-case (MRMC) comparative effectiveness study, nor any AI assistance in the provided document. The device is a patient monitoring system, not an AI-driven diagnostic tool that would typically involve human readers interpreting results with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable in the sense of an "algorithm only" performance for a diagnostic task. The "standalone" performance shown is the inherent performance of the integrated hardware and software system (Star 65) measuring physiological parameters, as assessed through bench testing against standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance testing, the "ground truth" was defined by the technical specifications and accuracy requirements set forth in the international consensus standards (e.g., IEC 60601 series, ISO 80601 series) to which the device was tested for compliance. For example, for NIBP accuracy, the ground truth standard is +/-5mmHg with a standard deviation greater than 8 mmHg.

8. The sample size for the training set

This section is not applicable. The document does not describe the use of machine learning or AI models that would require a "training set." The device is a traditional multi-parameter patient monitoring system.

9. How the ground truth for the training set was established

This section is not applicable, as there was no training set mentioned in the document.

Ask a specific question about this device

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.

Ask a specific question about this device