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510(k) Data Aggregation
(56 days)
STAR (LUNAR SERIES) MONITORING SYSTEM
The STAR (LUNAR SERIES) multiparameter 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 (Lead I / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration and Invasive Blood pressure (IBP1 & IBP2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & 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 STAR unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry and Invasive BP. STAR is a four channel monitor with waveform display capability for ECG (Lead I / II / III / V / AVL / AVF / AVR), Picthysmograph, Respiration and Invasive Blood pressure (IBP1 & IBP2). It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mcan) and Temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters cxccpt NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. Print out of tabular trend and ECG waveform can be obtained through an optional inkjet printer or paper chart recorder.
1. Table of acceptance criteria and the reported device performance
The document provided (K032867) is a 510(k) summary for a patient monitoring system, which focuses on demonstrating substantial equivalence to predicate devices rather than setting specific acceptance criteria and performance against them. Therefore, a direct table of acceptance criteria and reported device performance as typically understood for a novel device validation is not explicitly present.
However, the document states: "The no. of channels, range and accuracy of the parameters & method of sensing are similar to the predicate devices." This implies that the acceptance criteria are implicitly tied to matching the performance of the predicate devices. The study conducted essentially demonstrated this "similarity" or "equivalence".
Implicit Acceptance Criteria (based on predicate device comparison):
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| No. of Channels (ECG, Respiration, Temp, NIBP, SpO2, IBP) | Similar to Eagle 3000 (K952474) and CSI Model 8100 (K001020) | Similar to predicate devices |
| Range of Parameters | Similar to predicate devices | Similar to predicate devices |
| Accuracy of Parameters | Similar to predicate devices | Similar to predicate devices |
| Method of Sensing | Similar to predicate devices | Similar to predicate devices |
| Alarms (Audible & Visual) | Similar to predicate devices | Provided similar to predicate devices |
| Display (TFT color) | Similar to CSI Model 8100 | TFT color display |
| Weight | Comparable to Marquette Eagle 3000 | Comparable with Marquette Eagle 3000 |
| Battery (Type & Presence) | Similar to CSI Model 8100 | 2 sealed lead acid batteries provided |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" and a "sample size" in the context of a clinical performance study with patients or data. The comparison is based on the technological characteristics of the new device against the predicate devices. There is no mention of patient data being used for evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "test set" of patient data requiring expert ground truth establishment. The evaluation was a comparison of technical specifications against existing marketed devices.
4. Adjudication method for the test set
Not applicable. As no test set with patient data was used, there was no need for an adjudication method.
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-powered diagnostic imaging or interpretation tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a "Patient Monitoring System," which inherently involves displaying real-time physiological parameters to a human healthcare provider. It is not an algorithm performing a standalone diagnostic function without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "study" (which is primarily a technical comparison) is implicitly the established performance and specifications of the legally marketed predicate devices. The new device's performance is asserted to be "similar" or "comparable" to these predicates.
8. The sample size for the training set
Not applicable. This device is not an AI/Machine Learning algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable. There was no training set.
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