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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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C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker.

The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is intended to be used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. Other parameters can be applied to adult, pediatric or neonate.

The provided text is a 510(k) Summary for the Shenzhen Comen Medical Instruments Co., Ltd. Multi-parameter Patient Monitor, Model C30. It describes the device's characteristics, intended use, and comparisons to legally marketed predicate devices.

However, the document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific clinical study for the device's performance in isolation. The testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and adherence to performance standards, along with some clinical verification for NIBP and respiration rate accuracy.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of an AI algorithm's performance (such as sensitivity, specificity, or reader improvement) is not directly available or applicable to this type of medical device submission. This document describes a traditional multi-parameter patient monitor, not an AI-powered diagnostic device.

Based on the provided text, here's what can be extracted and what cannot be provided:

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

The document lists various performance characteristics for each parameter (ECG, Respiration, Temperature, SpO2, Pulse Rate, NIBP, CO2) as part of the technological comparison to predicate devices, including measurement ranges and accuracies. These can be considered the de facto performance criteria. While the document states the device was "tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards," it does not provide a specific table of acceptance criteria with corresponding measured performance for each parameter from a single comprehensive study report. Instead, it infers compliance through comparison to predicate device specifications and adherence to standards.

2. Sample size used for the test set and the data provenance:

• NIBP Clinical Study: The document states "According to ISO 81060-2:2013, NIBP clinical accuracy was verified." This standard specifies requirements for Non-Invasive Sphygmomanometers, including clinical investigation procedures. However, the exact sample size for this specific study and the data provenance (country, retrospective/prospective) are not given in this summary.
• Respiration Rate Clinical Study: "To verify respiration rate (RR) accuracy, Clinical study was conducted comparing the RR from the subject device with that from capnography." The exact sample size and data provenance are not given.
• For other parameters, bench testing and compliance with standards are mentioned, but no specific clinical test sets or sample sizes are detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as this is not an AI diagnostic device and does not inherently involve expert image interpretation or similar processes for ground truth establishment. Clinical studies mentioned (NIBP, RR) would likely use reference measurements from other validated medical devices as a "ground truth" or comparator, but details on expert involvement are absent.

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

This information is not applicable/provided. Adjudication methods are typically used in studies involving subjective assessments, especially common in AI diagnostic imaging where multiple readers reconcile disagreements. This device is a physiological monitor measuring objective parameters.

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:

This information is not applicable/provided. This is a physiological monitoring device, not an AI-powered diagnostic tool intended to assist human readers in interpreting complex medical data or images. Therefore, an MRMC study is beyond the scope of this type of device.

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

This information is not applicable/provided. This device is a multi-parameter patient monitor that measures physiological signals directly rather than an AI algorithm performing a standalone diagnostic function. The device's performance is its direct measurement output, which is then used by healthcare professionals.

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

For the NIBP and Respiration Rate clinical studies, the "ground truth" would likely be established through reference measurements from other validated medical devices or established clinical methods. For example, NIBP accuracy usually compares the device's readings to those obtained through an invasive arterial line or another highly accurate, validated NIBP device. For respiration rate, capnography (a precise measurement of CO2 in exhaled breath) was explicitly mentioned as the comparator.

8. The sample size for the training set:

The device described is a traditional patient monitor developed through engineering and design principles, not a machine learning or AI model that requires a "training set." Therefore, this concept is not applicable to this product.

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

As above, the concept of a "training set" and "ground truth for the training set" is not applicable to this traditional medical device.

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The PMS8210A Multi Parameter Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Patient Monitor has certain features and functions.

The patient parameters that can be monitored by PMS8210A Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.

The PMS8210A Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.

The PMS8210A Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.

PMS8210A Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), Heart rate (HR) and Pulse Rate (PR), The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user.

The provided text does not contain detailed information about specific studies, acceptance criteria, or performance data for the PMS8210A (IRIS) Multi-parameter Patient Monitor. Instead, it focuses on comparing the device's technical specifications and adherence to various medical standards with a predicate device (PM-9000 EXPRESS PATIENT MONITOR).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information.

The document primarily acts as a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness and are as safe and effective as the predicate device.

The study described is a comparison of the PMS8210A Multi-parameter Patient Monitor's specifications and compliance with relevant medical standards against a predicate device, the PM-9000 EXPRESS PATIENT MONITOR (K053234). The intent is to demonstrate that the subject device is substantially equivalent to the predicate device.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various technical specifications and accuracy claims for the PMS8210A device (Subject Device) and compares them to the predicate device. While these are performance characteristics, they are not explicitly labeled as "acceptance criteria" through a formal study results table. The implication is that meeting or being comparable to the predicate's performance, and adhering to referenced standards, constitutes meeting acceptance criteria for substantial equivalence.

2. Sample size used for the test set and the data provenance:
This information is not provided in the given text. The document refers to "performance testing in accordance with IEC standards" but does not detail the size or nature of the test set or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. The document focuses on technical specifications and standard compliance, not clinical ground truth establishment by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the given text.

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:
This information is not applicable/provided. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone monitor. Its performance is assessed against technical specifications and standards (e.g., IEC, AAMI, EN, ISO). The document states the device has "software of Moderate concern" and that "the appropriate level of Software evaluation was performed," but does not detail the standalone performance study specific to an algorithm. The overall product performance is standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for evaluating the device's technical specifications and accuracy is largely based on measurements against established reference standards and calibrated equipment, as implied by adherence to standards like ANSI/AAMI SP10 for NIBP accuracy and ASTM E1112 for temperature accuracy. For SpO2, it leverages the Nellcor SpO2 module, implying its proven accuracy. There is no mention of expert consensus, pathology, or outcomes data as ground truth in this document.

8. The sample size for the training set:
This information is not provided in the given text. As a patient monitor rather than an AI/ML algorithm requiring a training set in the typical sense, this concept might not directly apply or is not detailed. The "software of Moderate concern" does not imply a classical AI/ML model.

9. How the ground truth for the training set was established:
This information is not provided in the given text, and likely not applicable in the context of this traditional medical device.

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