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The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the benside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also disolay the digital wallus of PR, SpO2, Non-Invasive Blood Pressure (Systolic Diastolic and Mean) and Temperature readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.

This STELLAR 300 unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.

STELLAR 300 have waveform display capability for Plethysmograph. It also displays Meen of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Displays Mean) and Temperatire readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.

This document is a 510(k) summary for the STELLAR 300 Patient Monitoring System, seeking clearance for a neonate mode addition. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new AI/software-as-a-medical-device.

Based on the provided text, the following information can be extracted, with significant limitations for aspects related to "acceptance criteria" and "study" in the context of detailed performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for vital sign monitoring. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, STELLAR 404T. The "reported device performance" is essentially that its parameters are "similar" to the predicate.

The statement on page 3, "The range and accuracy of the parameters & method of sensing are similar to the predicate devices," is the closest the document comes to defining performance. A detailed comparison would likely be contained in the "Substantial Equivalence Equipment comparison" document, which is referenced but not provided here.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set or any performance studies with human subjects for the NIBP, Pulse Oximetry, or Temperature parameters, nor does it describe data provenance (e.g., country of origin, retrospective/prospective). The claim of similarity to the predicate likely relies on engineering testing and comparison of technical specifications, rather than a clinical performance study with a distinct test set.

For the addition of the "Neonate mode," the document states, "STELLAR 300 device with Adult & Pediatric mode is already FDA approved -K093017. In this submission, Neonate mode is added to STELLAR 300." This suggests that the extension to neonates might be justified based on established technology and potentially bench testing or comparisons to standards without a new clinical study in neonates described in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. As there's no mention of a clinical performance study with a test set requiring ground truth established by experts, this detail is absent.

4. Adjudication Method

This information is not provided in the document. There is no mention of a study involving expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is involved. The STELLAR 300 is a patient vital signs monitor. Therefore, an MRMC comparative effectiveness study was not done as it is not applicable for this type of device. The concept of "human readers improve with AI vs without AI assistance" does not apply to a vital signs monitor.

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

The STELLAR 300 is a hardware device that measures vital signs. Its core function is to produce quantitative measurements (NIBP, SpO2, Temperature). Its performance is inherently standalone in the sense that the device measures and displays these parameters directly. It's not an AI algorithm that provides an輔助 diagnosis needing "human-in-the-loop" interaction in the described context. Therefore, the device operates in a standalone capacity by providing raw vital sign data.

7. The Type of Ground Truth Used

Given the nature of a patient monitor, the ground truth for vital sign parameters would typically be established using reference standard measurement devices (e.g., a calibrated sphygmomanometer for NIBP, a co-oximeter for SpO2, a calibrated thermometer for temperature). The document does not explicitly state the type of ground truth used, but it implies that performance is evaluated against established standards or a predicate device.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is because the STELLAR 300 is a traditional medical device (patient monitor) and not an AI/Machine Learning device that undergoes a "training" phase in the computational sense. Its design and validation rely on engineering principles, compliance with standards (IEC 60601-1, IEC 60601-1-2), and comparison to a predicate device.

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

As there is no training set in the AI/ML sense, this question is not applicable to the STELLAR 300 device as described in this 510(k) summary.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes the "study" (or rather, the justification for substantial equivalence) as a comparison to a legally marketed predicate device, STELLAR 404T (K060058). The core argument is based on the technological characteristics of the STELLAR 300 being "similar" to the predicate device regarding primary parameters (NIBP, Pulse Oximetry, Temperature), their range, accuracy, and method of sensing. Other features like display, recorder, alarm functionality, and battery type are also cited as similar. The addition of the neonate mode to the STELLAR 300 is an extension to an already FDA-approved device for adult and pediatric use (K093017).

The document states, "Comparison of all the parameters of STELLAR 300 to that of the predicate devices is given in the 'Substantial Equivalence Equipment comparison' document." This implies that a detailed technical comparison, likely including bench testing against specifications or established standards, was performed to support the claim of similarity in range and accuracy.

Compliance with international standards (IEC 60601-1 for safety and IEC 60601-1-2 for EMC) further supports the device's acceptable performance and safety. The conclusion is that the device "doesn't pose any additional risk on safety & effectiveness of the device" compared to the predicate.

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