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The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.

All parameters can be monitored on single adult, pediatric, and neonatal patients except:

• · BIS monitoring is intended for adult and pediatric patients only;
• · C.O. monitoring is restricted to adult patients only;
  · Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
• · When using COMEM SpO2, the monitor is intended to be used on adult patients only.
• · NIBP measurement continual mode is not applicable to neonates.

The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.

The monitors are not intended for helicopter transport, hospital ambulance, or home use.

The monitors do not measure, display, or trend changes in the ST segment.

The monitors do not intend for use as apnea monitors.

The monitors are not intended for use in MRI or CT environments.

The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing multiple physiological parameters. These parameters include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intended and shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with:
Same system framework and components
Same hardware design principle
Same software platform
Same parameters measurement subsystems (including parameters modules and accessories)
The only difference between NC10 and NC12 is the display size.

The acceptance criteria and supporting study details for the Multi-Parameter Patient Monitor (NC10 and NC12) are provided below, based on the given FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present specific "acceptance criteria" for each physiological parameter in a tabular format with corresponding "reported device performance." Instead, it compares the subject device's specifications to those of the predicate device, stating that the subject device's performance aligns with or is a subset of the predicate's performance, and that the device meets relevant consensus standards. The "Comparison" column in the provided tables indicates "Same" for most parameters, implying that the subject device's performance is equivalent to the established performance of the predicate device. For the "Comen SpO2" feature, where there's a difference, the document states, "The SpO2 accuracy met ISO 80601-2-61 and was validated by the clinical study," indicating that its performance meets the standard.

Here's a condensed representation of the key performance specifications for the subject device (NC10 and NC12), which also serve as implied acceptance criteria given the "Same" comparison to the predicate:

The document implies that the "reported device performance" for the subject device meets or is equivalent to these specified ranges and accuracies through bench testing and clinical studies, confirming compliance with relevant standards.

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

• Sample Size for Test Set: The document does not specify exact numerical sample sizes for each clinical test. It mentions that clinical accuracy of NIBP, SpO2, and respiratory rate were validated for the intended patient population.
  • For SpO2 accuracy, it states the validation was done "using the method outlined in ISO 80601-2-61:2017 and the FDA guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, March 2013." These standards typically require a certain number of subjects (often healthy volunteers) with induced hypoxemia for desaturation studies to demonstrate accuracy across the specified range. However, the exact number is not provided in this summary.
  • For NIBP accuracy, it states validation was "according to ISO 81060-2 which contains the requirements for clinical accuracy and the protocols for investigating the NIBP determination clinical accuracy." This standard also prescribes specific subject enrollment criteria and measurement methods.
  • For Respiratory Rate (RR) accuracy, it was validated "by clinical testing to compare the measurement of the subject device and that of a clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography." The sample size for this is not detailed.
• Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the studies were retrospective or prospective, though clinical validation studies for device clearance are typically prospective. It does say "All clinical accuracy validation studies were conducted in accordance with standard ISO 14155:2020," which governs clinical investigation of medical devices, generally implying prospective collection.

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

The document does not provide details on the number or qualifications of experts used for establishing ground truth, as it is a multi-parameter patient monitor.

• For SpO2, the ground truth would typically be established by a CO-oximeter reading during a controlled desaturation study, as per ISO 80601-2-61. This is a highly objective measurement.
• For NIBP, ground truth is typically established by direct intra-arterial blood pressure measurements, not by expert consensus.
• For Respiratory Rate, the ground truth was "clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography." This implies clinically trained personnel, but their specific qualifications or number are not provided.
• For Arrhythmia Analysis, and other subjective physiological monitoring parameters, the ground truth source is not explicitly mentioned but typically relies on expert interpretation of ECG waveforms or other data.

4. Adjudication Method for the Test Set

The document does not detail any adjudication methods (e.g., 2+1, 3+1) for the test set, as most of the parameters are quantitative measurements compared against an objective reference standard rather than subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This document describes a multi-parameter patient monitor, which is a measurement device, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this type of device and was not conducted. The study aims to demonstrate that the device's measurements are accurate and equivalent to predicate devices, not to show an improvement in human reader performance.

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

The entire device, including its algorithms for parameter measurement and arrhythmia detection, operates in a "standalone" fashion to generate the values and alarms displayed to the clinician. The performance validated (e.g., accuracy of SpO2, NIBP, RR, arrhythmia detection) is the inherent performance of the device's algorithms and hardware. While a human uses the device and interprets its output, the core measurements are algorithm-driven.

7. The Type of Ground Truth Used

• SpO2: CO-oximetry in a controlled desaturation study (objective, gold-standard reference for SpO2 saturation).
• NIBP: Direct intra-arterial blood pressure measurements (objective, gold-standard).
• Respiratory Rate: Clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography. (This suggests an expert-derived observation from an objective measurement, or comparison to another well-established measurement device).
• ECG/Arrhythmia Detection and other parameters: The document implies comparison to established methods and compliance with relevant ISO standards, which would typically involve highly accurate reference measurements and possibly expert review of waveforms for specific event detection.

8. The Sample Size for the Training Set

The document does not provide information about a training set or its sample size. This is common for device clearances that focus on performance validation rather than machine learning algorithm development where distinct training and test sets are crucial. The device's algorithms are likely based on established physiological principles and signal processing, rather than deep learning from a massive training dataset.

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

As no specific training set is mentioned in the filing summary for this device, information regarding the establishment of its ground truth is not applicable or provided. The device's performance is demonstrated through its adherence to established international standards and clinical testing against reference methods.

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