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The Star 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unpin Vital signs parameters include ECG (3 lead / 5 lead), SpO2, Respiration, Temperature, external optional 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, Diastolic and Mean), Temperature, EyCO2, and FiCO2.

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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

STAR 50N is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, SpO2 and external CO2 (optional).

STAR 50N is a 6-channel monitor with 10.4" 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 and FiCO2 readings. It has 168 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. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It has got optional communication features - USB, Wi/Fi (optional) and Ethernet. This monitor can also be connected to L&T Central Nursing Station (Skyline 55) and an external LCD-TFT display

This document is a 510(k) summary for the STAR 50N Patient Monitoring System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

Therefore, many of the requested fields cannot be filled directly from the provided text, as the document describes a regulatory submission based on comparison to existing devices, not a de novo study proving new acceptance criteria.

Here's an analysis based on the provided text, highlighting what information can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance for the STAR 50N in the traditional sense of a clinical or technical validation study with specific metrics (e.g., accuracy, sensitivity, specificity). Instead, it states that the device is substantially equivalent to predicate devices.

The acceptance criteria are implicitly met by demonstrating that the STAR 50N shares the "same" technological characteristics and principles of operation, and performs "as well as" or "no worse than" the predicate devices. The document explicitly states:

Reported Device Performance: The only "performance" reported is that the characteristics are "Same" as the predicate devices. No specific numerical performance metrics are provided for the STAR 50N itself from a new study within this summary.

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 does not describe a new clinical test set or data collection for the STAR 50N. The basis for comparison is the performance of the predicate devices.

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. No ground truth establishment for a new test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new 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

Not applicable. This device is a patient monitoring system, not an AI-assisted diagnostic tool for human readers.

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

This is an integrated patient monitoring system. Its primary "performance" is the accurate capture and display of physiological parameters, which is implicitly standalone in its function once calibrated. However, the exact type of "standalone" study (e.g., specific accuracy tests against reference standards) is not detailed in this summary; instead, compliance with standards (IEC 60601-1, IEC 60601-1-2) which would involve such testing, is mentioned.

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

Not explicitly stated for the STAR 50N in a new study. For the predicate devices' prior approvals, the ground truth for vital sign measurements (ECG, SpO2, NIBP, etc.) would typically be reference standards (e.g., skilled manual blood pressure readings, reference ECG machines, oximeter simulators) according to recognized medical device standards.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI models with a "training set."

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

Not applicable. No training set is described.

Summary of what the document does provide regarding acceptance criteria and study:

The document serves as a 510(k) summary, which is a submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices. The "study" in this context is primarily a comparison of technological characteristics and intended use between the new device (STAR 50N) and already approved predicate devices (STAR 55 and Stellar 300).

Implicit Acceptance Criteria: The primary acceptance criterion for a 510(k) is that the new device is substantially equivalent to a predicate device in terms of:

• Intended Use: The STAR 50N shares the same intended use (monitoring vital signs for adult, pediatric, and neonatal patients at the bedside or during intra-hospital transport) as its predicates.
• Technological Characteristics: The document asserts that the parameters (ECG, Respiration, Temperature, SpO2, IBP, Capnography, NIBP) are "Same" as those of the predicate devices. This implies that the underlying technology for measuring these parameters is similar enough not to raise new questions of safety or effectiveness.
• Safety and Effectiveness: L&T believes the device "doesn't pose any additional risk on safety & effectiveness" when compared to the predicates, supported by compliance with international standards IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance).

"Study" Proving Acceptance: The "study" that proves these criteria are met is the comparison document (mentioned as "Substantial Equivalence Equipment comparison" document, though not fully provided) that systematically details the technological characteristics of the STAR 50N against those of the predicate devices (STAR 55 and Stellar 300). The conclusion is that because the device is "substantially equivalent," it meets the regulatory requirements for market clearance without requiring a new, comprehensive clinical trial for performance metrics beyond what the predicate devices already established.

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