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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.

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.

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The PLANET 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 (3 lead), Plethysmograph. It can also display the digital values of HR/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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.

PLANET is a multi-parameter Patient Monitoring System (TFT color monitor) with ECG (3 lead),Temperature,NIPB, and pulse oximetry)with an optional built-in two channel thermal array recorder which can record online data (ECG waveform and plethysmograph) along with numerical values of other parameters. PLANET is a three channel monitor with waveform display capability for ECG (3 lead), cascade and plethysmograph. It also displays the digital values of heart rate, pulse rate, SpO2, non-invasive blood pressure (systolic, diastolic and mean) and temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for ECG, SpO2 and temperature. It has special tabular trend for NIPB to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions. Printout of tabular trend and ECG waveform can be obtained through an optional inkjet printer.

The provided text is a 510(k) summary for the PLANET Monitoring System, a multi-parameter patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with standards, rather than presenting a detailed study proving performance against specific acceptance criteria for AI/ML features.

Therefore, the requested information elements such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not present in the provided document. This type of information is typically required for AI/ML device submissions, which were not the focus of this 2003 submission for a traditional patient monitor.

Here's a breakdown of what can be extracted and what is missing:

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

The document states: "The range and accuracy of the parameters & method of sensing are similar to the predicate devices." It also lists compliance with several international standards. However, specific numerical acceptance criteria (e.g., accuracy +/- X% for heart rate) and reported performance values are not provided within this summary for specific vital signs parameters. The table below reflects the general claims made about similarity and compliance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document focuses on technological similarities and compliance with engineering standards, not on clinical performance studies with test sets.

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/Not provided. This is relevant for AI/ML performance evaluation, which is not described.

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

• Not applicable/Not provided. This is relevant for AI/ML performance evaluation, which is not 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/Not provided. This is a traditional patient monitor without AI assistance described in the 510(k) summary.

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

• Not applicable/Not provided. This is a traditional patient monitor without a standalone algorithm as defined for AI/ML.

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

• Not applicable/Not provided. Ground truth for AI/ML training/testing is not part of this submission's summary. The "ground truth" for this device would be considered the physical measurements from validated sensors/methods, and the document implies these are similar to predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a training set as this is not an AI/ML device.

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

• Not applicable/Not provided. There is no mention of a training set.

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