(255 days)
Star 60 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3L / 5L), SpO2, Respiration, Temperature, NIBP, IBP, IBP and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, 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.
STAR 60 is a patient monitor with a wide range of communication options. Capacitive sensing buttons in keyboard is introduced. It fits in clearly to a new age of patient monitoring.
- ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the main board and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the main board.
- SpO2: This module is inbuilt inside the monitor on the main board. It is used to measure the partial pressure of oxygen in the human body.
- . NIBP: This module is inbuilt inside the monitor on to the chassis. It is used to non-invasively measure the systolic, diastolic & mean blood pressure.
- CO2: This module is inbuilt inside the monitor on to the chassis. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2).
- . IBP: STAR 60 can support IBP modules. For ease of understands we shall name as IBP1 & IBP 2. IBP 1/2 module is inbuilt on the main board. It is used to invasively measure the systolic and diastolic blood pressure.
Here's an analysis of the acceptance criteria and study information for the Skanray Technologies Private Limited Star 60 patient monitoring system, based only on the provided text.
It's important to note that this document is a 510(k) summary, not a full clinical study report. Therefore, detailed acceptance criteria for specific performance metrics (like accuracy ranges for ECG, SpO2, NIBP, etc.) and comprehensive study results are generally not found in this type of FDA document. Instead, it refers to compliance with recognized standards.
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for the Star 60 is implied by its adherence to various recognized medical device standards. The "reported device performance" is primarily the statement of substantial equivalence to predicate devices. This means the device is considered to perform "as well as or better than" the predicate devices and meets the safety and effectiveness requirements outlined in the standards.
| Acceptance Criterion (Implied by Standard Compliance) | Reported Device Performance (Summary Statement) |
|---|---|
| Electrical Safety (IEC 60601-1) | Device passed Electrical and EMC Testing. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| EMC Compliance (IEC 60601-1-2) | Device passed Electrical and EMC Testing. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Usability (IEC 60601-1-6) | Device passed all non-clinical tests. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Alarm Systems (IEC 60601-1-8) | Device passed all non-clinical tests. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| ECG Monitoring Performance (IEC 60601-2-27, ANSI/AAMI EC 13) | Device passed all non-clinical tests specifically for ECG. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| NIBP Monitoring Performance (IEC 80601-2-30, ANSI/AAMI SP10) | Device passed all non-clinical tests specifically for NIBP. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| IBP Monitoring Performance (IEC 60601-2-34) | Device passed all non-clinical tests specifically for IBP. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Multifunction Patient Monitoring Performance (IEC 60601-2-49) | Device passed all non-clinical tests. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Respiratory Gas Monitoring Performance (CO2) (ISO 80601-2-55) | Device passed all non-clinical tests specifically for CO2. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Temperature Measurement Performance (ISO 80601-2-56) | Device passed all non-clinical tests specifically for Temperature. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Pulse Oximeter (SpO2) Performance (ISO 80601-2-61) | Device passed all non-clinical tests specifically for SpO2. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Software Life Cycle Processes (IEC 62304) | Device passed all non-clinical tests related to software. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
| Risk Management (ISO 14971) | Device passed all non-clinical tests related to risk management. Deemed "as safe, as effective, and performs as well as or better than the predicate device." |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- The document describes "Non Clinical Testing" which includes electrical and EMC tests and compliance with various IEC/ISO/ANSI/AAMI standards. These are typically laboratory-based tests of the device itself and its components, often using test equipment, simulators, and phantoms, rather than patient data.
- No sample size for a "test set" from patient data is mentioned for performance evaluation.
- Data provenance is not applicable in the context of these non-clinical, lab-based engineering and performance tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The testing described is non-clinical, focused on engineering and performance standards, not diagnostic or clinical interpretation needing expert ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to clinical studies where multiple human readers assess data, and a consensus method is used to establish ground truth or resolve discrepancies. The described tests are non-clinical hardware/software performance evaluations against known physical parameters or standard requirements.
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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 MRMC study was reported. The Star 60 is a patient monitor, not an AI-assisted diagnostic tool that requires human interpretation in the same way. The document does not mention any AI components or human-in-the-loop performance studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, a "standalone" evaluation was done through the non-clinical testing. The device's direct performance (e.g., accuracy of ECG readings, NIBP measurements, SpO2 detection, etc.) was assessed against established standards purely based on its internal functioning, without human intervention for interpretation beyond operating the test equipment. However, this is not an "algorithm only" study in the sense of a standalone AI algorithm. It's a standalone device performance test.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be:
- Reference standards/equipment: Calibrated test equipment (e.g., ECG simulators, NIBP simulators, SpO2 testers, temperature probes) providing known, accurate values.
- Established engineering specifications: Performance limits defined by the relevant IEC/ISO/ANSI/AAMI standards.
- For the non-clinical tests, the "ground truth" would be:
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The sample size for the training set:
- Not applicable / Not provided. The document does not describe a machine learning or AI algorithm that would require a "training set" for its development. The device is a traditional patient monitor.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As no training set is mentioned, this information is not relevant to the described testing.
§ 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).