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The STAR 55 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 along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, 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.

STAR 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, Sp02, CO2 & Gas monitoring.

STAR 55 is a 8-channel monitor with 12.1" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings. It has selective 24\48\72 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication features - USB, RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The provided document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and compliance with general safety standards, rather than presenting a specific performance study with detailed acceptance criteria.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a dedicated study for the STAR 55. Instead, it relies on demonstrating that "The parameters available with the aLarsen & Toubro Limited make STAR 55 Patient monitoring system are available with the predicate devices - aLarsen & Toubro Limited make STAR 50 patient monitoring system & Mindray Co., Ltd. PM 9000 patient monitor for Gas monitoring."

The "Conclusion" states: "Based on the Technological characteristics of STAR 55 and its comparison with that of predicate devices Star 50 and PM 9000 Express for gas monitoring, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitors and doesn't pose any additional risk on safety & effectiveness of the device."

This implies that the acceptance criterion for the STAR 55's performance is that it performs similarly to the predicate devices across all measured parameters, and the reported device performance is that it meets this unstated, but implied, substantial equivalence.

Without explicit values from the document, a table cannot be fully constructed. However, if we interpret "acceptance criteria" as "compliance with predicate device functionality," then the table would look something like this:

2. Sample Size for the Test Set and Data Provenance

The document does not provide details of a specific clinical performance study with a test set, sample size, or data provenance. The assessment is based on a comparison of technological characteristics with predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no clinical study with ground truth established by experts is described. The assessment is based on comparison to existing legally marketed devices.

4. Adjudication Method

Not applicable, as no clinical study requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The document describes a comparison to predicate devices, not a study evaluating human reader performance with and without AI assistance.

6. Standalone Performance Study

A standalone performance study, as typically understood for an algorithm or AI, is not described. The document focuses on the device as a whole system and its equivalence to other patient monitors. However, the compliance to standards like IEC 60601-1 Medical Electrical safety and IEC 60601-1-2 EMC compliance implies that standalone technical performance evaluations (e.g., accuracy of parameter measurements, electrical safety) were conducted, but the details of these tests are not provided in this summary.

7. Type of Ground Truth Used

The concept of "ground truth" in the context of clinical images or advanced algorithms is not applicable here. The "truth" for this submission is the established performance and safety of the predicate devices. The claim is that the new device's technological characteristics are equivalent, implying its performance is also equivalent.

8. Sample Size for the Training Set

Not applicable, as this device is a hardware patient monitoring system, not an AI/ML algorithm that typically requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

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