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The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3, 5 or 12 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) .
• . SpO2
• Respiration .
• Temperature up to 2 channels (Dual Temperature) .
• . CO2
• IBP .
• Anesthetic agents .

The target population is for adult, neonate and pediatric patients.

It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3, 5 or 12 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) .
• SpO2 .
• Respiration .
• Temperature up to 2 channels (Dual Temperature) .
• . CO2
• . Cardiac Output
• IBP .
• . Anesthetic agents

The target population is for adult, neonate and pediatric patients with the exception of:

• · Cardiac Output for which the target population is adult only.
  It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3, 5 or 12 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) .
• SpO2 .
• Respiration .
• Temperature up to 2 channels (Dual Temperature) .
• CO2 .
• Cardiac Output ●
• . IBP
• Anesthetic agents .

The target population is for adult, neonate and pediatric patients with the exception of:

• · Cardiac Output for which the target population is adult only.
  It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3 to 5 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) ●
• . SpO2
• . Respiration
• . Temperature - up to 2 channels (Dual Temperature)
• CO2
• . Anesthetic agents

The target population is for adult, neonate and pediatric patients.

It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The OMNI monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, and processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability, Built-in battery facilitates transportation of patient.

The OMNI III can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The OMNI EXPRESS monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters, It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI EXPRESS monitor can be powered by an internal battery pack that provides 2 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

This document describes several patient monitors (OMNI, OMNI II, OMNI III, and OMNI Express) and their performance with respect to various physiological parameters. However, the provided text does not contain specific acceptance criteria, reported device performance values against these criteria, or a detailed study description with sample sizes, data provenance, ground truth establishment, or expert qualifications.

The document discusses substantial equivalence to predicate devices and lists performance tests conducted according to certain standards, but it does not explicitly state the quantitative acceptance criteria or the specific results obtained in numerical terms.

Therefore, I cannot fully complete the requested table and answer many of the questions directly. However, I can extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria and corresponding reported device performance values are NOT explicitly stated. The document refers to compliance with performance standards rather than specific numerical targets.

The table below indicates the standards of compliance mentioned for certain parameters, which would imply that the device met the requirements of these standards.

Note: The document only states that testing was completed according to these standards and that "Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." It does not provide the specific numerical results or tolerance limits (acceptance criteria) from these tests.

Study Details:

As the document primarily focuses on demonstrating substantial equivalence through compliance with recognized standards and non-clinical bench testing, it does not describe a clinical study in the conventional sense (e.g., with human subjects, test sets, ground truth panels, etc., for evaluating classification performance or diagnostic accuracy). The non-clinical data section references "bench testing" only.

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

   • Not explicitly stated. The document refers to "bench testing" and compliance with performance standards. These are typically laboratory tests using simulated signals or controlled environments, not human subject data sets as "test sets" in the context of AI/diagnostic algorithm evaluation.

2. 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 stated. Since this is bench testing against performance standards, "ground truth" would be established by the characteristics of the test equipment or reference signals used to simulate physiological parameters, not by human expert consensus on clinical data.

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

   • Not applicable / Not stated. Adjudication methods are relevant for clinical studies where multiple experts interpret data. This document describes bench testing.

4. 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:

   • No. The document does not describe any MRMC study. These are patient physiological monitors, not AI-assisted diagnostic tools for image interpretation or similar.

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

   • Partially applicable, but for hardware/software performance, not an AI algorithm. The "bench testing" described evaluates the device (hardware and embedded software) in a standalone capacity against technical standards for performance (e.g., accuracy of ECG measurement, IBP measurement, etc.). It is not a standalone evaluation of an AI algorithm in the context of diagnostic decision-making.

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

   • Not explicitly stated in clinical terms. For bench testing against standards, the "ground truth" would be the known, controlled inputs provided by test equipment or calibrated sources, as defined by the respective performance standards (e.g., a signal generator producing a known ECG waveform or a pressure calibrator for IBP).

7. The sample size for the training set:

   • Not applicable / Not stated. The document describes a patient monitor that monitors basic physiological parameters. There's no indication of machine learning or an "AI algorithm" requiring a training set in the context of the information provided for this 510(k) summary. The device's functionality appears to be based on established signal processing and measurement techniques, not learned models.

8. How the ground truth for the training set was established:

   • Not applicable / Not stated. As above, no training set for an AI algorithm is mentioned.

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