(12 days)
The STAR 50 unit is a 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 (Lead I / II/ III / V / AVL / AVF AVR), Plethysmograph, Respiration, Invasive Blood Pressure (IBP1 & IBP2) and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (systolic, diastolic and mean) and Temperature, EtCO2 and FiCO2 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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.
This STAR 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Capnography and Invasive BP.
STAR 50 is a four channel monitor with waveform display capability for ECG (Lead 1 / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2) and Capnography (CO2). It also displays the digital values of HRPR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters except NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. STAR 50 has got a optional Thermal recorder for printing Tabular trends & waveforms.
This looks like a 510(k) premarket notification for a patient monitoring system, which typically compares a new device to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance data for a standalone algorithm. Therefore, many of the requested categories for AI/algorithm-specific studies are not applicable directly from this document.
However, I can extract the relevant information from the provided text regarding the device's characteristics compared to predicate devices, which serves as the "proof" of meeting "acceptance criteria" (i.e., substantial equivalence).
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of precise numerical acceptance criteria and a detailed, quantitative performance report for the STAR 50. Instead, it asserts substantial equivalence by stating that the "no. of channels, range and accuracy of the parameters & method of sensing are similar to the predicate devices."
The "acceptance criteria" here are implicitly that the STAR 50's performance for each vital sign parameter is similar to that of the predicate devices. The "reported device performance" is the claim of this similarity.
| Parameter Category | Acceptance Criteria (Implied by Predicate Device Comparison) | Reported Device Performance (Claimed for STAR 50) |
|---|---|---|
| General Functionality | Monitor vital signs in adult, pediatric, neonatal patients. Display ECG, Respiration, Temperature, NIBP, Pulse Oximetry, Capnography, Invasive BP. | Monitors: ECG (3/5 lead), Respiration, Temperature (2 channels), NIBP, Pulse Oximetry, Capnography, Invasive BP (2 channels). Displays values for HR/PR, SpO2, RR, NIBP (Systolic, Diastolic, Mean), Temperature, EtCO2, FiCO2. |
| Number of Channels | Similar to predicate devices (Eagle 3000, Model 8100, STAR K032867) | Similar to predicate devices; STAR 50 is a four-channel monitor. |
| 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 alarms similar to predicate devices | Audible & visual alarms provided; graded and color-coded. |
| Display | TFT color display like CSI Model 8100. | TFT color display. |
| Battery | Battery (2 sealed lead acid) like predicate device CSI Model 8100. | Battery (2 sealed lead acid) provided. |
| Trends | (Not explicitly compared in terms of equivalence, but described) | 24 hours tabular and graphical trends for all parameters except NIBP (240 readings tabular trend). Last 16 alarm conditions recall. |
| Recorder | (Not explicitly compared in terms of equivalence, but described) | Optional Thermal recorder for printing tabular trends & waveforms. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable (N/A): This document is a 510(k) summary for a hardware patient monitoring system, not an AI/algorithm device with a separate "test set" in the context of an algorithm's performance. The comparison is based on the technical characteristics and intended use aligned with predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- N/A: See point 2. The "ground truth" for this type of device is established through compliance with recognized standards (IEC 60601 series) and comparison to the established performance of legally marketed predicate devices.
4. Adjudication Method for the Test Set
- N/A: See point 2.
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
- N/A: This is not an AI-assisted diagnostic or interpretation device. It's a vital signs monitor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A: Not an algorithm-only device.
7. The Type of Ground Truth Used
- The "ground truth" in this context is established by the performance and accepted characteristics of the legally marketed predicate devices (Eagle 3000 patient Monitoring System, Vital signs monitor Model 8100, and Patient Monitoring System - STAR K032867), coupled with compliance to international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27). The manufacturer argues "substantial equivalence" based on these factors.
8. The Sample Size for the Training Set
- N/A: Not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- N/A: See point 8.
§ 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).