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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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The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

· The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;

· NIBP measurement continual mode is not applicable to neonates;

· Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;

The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;
• NIBP measurement continual mode is not applicable to neonates;
• Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;
Those monitors provide patient monitoring capabilities by using corresponding accessories.
The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics:
But the software in the host and modules and components are different.
The differences between C50 and C80 are ICG, BIS and size of monitor.

The provided document describes the acceptance criteria and a study proving the C50 and C80 Multi-parameter Patient Monitor meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established through adherence to recognized international standards and clinical performance metrics. The document details a comparison with a predicate device (K170876, Passport Series Patient Monitors). While explicit "acceptance criteria" for each parameter are not always separately listed with a single performance value from the new device, the "Comparison" column in the table below infers if the new device meets or exceeds the predicate's performance or if sufficient justification is provided for differences.

Study that Proves the Device Meets Acceptance Criteria

The essential studies to prove the device meets acceptance criteria are divided into Non-Clinical Performance Data and Clinical Studies.

Non-Clinical Performance Data:

• Software Verification and Validation Testing: Conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Risk analysis was performed, and the software was deemed a "major" level of concern.
• Electrical safety and Electromagnetic Compatibility (EMC): Testing conducted according to:
  • ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (IEC 60601-1:2005, MOD)
  • IEC 60601-1-2 Edition 4: 2014-02
• Bench Testing: Functional and system-level tests were performed, showing the devices meet specifications and perform equivalently to the predicate.
• Biocompatibility Testing: Performed for patient-contacting components (ECG cable, SpO2 probes, temperature probes) that were not previously cleared. Cytotoxicity, sensitization, and irritation testing were conducted based on ISO 10993-1 and FDA's 2016 biocompatibility guidance.
• Conformance with Applicable Standards: The device demonstrated compliance with numerous recognized consensus standards, in addition to those listed above for specific modules (e.g., ISO 80601-2-55 for Respiratory Gas Monitors, ISO 80601-2-56 for Thermometers, ISO 80601-2-61 for Pulse Oximeter Equipment, ANSI AAMI EC57:2012 for Cardiac Rhythm and ST-Segment measurement algorithms).

Clinical Studies:

1. NIBP Clinical Study - for adults and children

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 25 patients (19 adults, 6 children).
  • Demographics: 10 men, 15 women. 6 patients aged 3-12, 2 aged 12-40, 10 aged 40-60, 7 above 60.
• Data Provenance: Retrospective or Prospective not explicitly stated, but implies prospective data collection from "The Second Affiliated Hospital of Guangzhou Medical University and The First Affiliated Hospital of Guangzhou Traditional Chinese Medical University" from 2012 to 2013 (China).
• Ground Truth: Implicitly referent method (e.g., auscultation by trained observers) as required by ISO 81060-2.
• Adjudication Method: Not specified, but standard practice for NIBP clinical validation involves multiple observers for reference measurements.
• Results: "The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials."

2. NIBP Clinical Study - for neonate and infants

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 20 subjects.
  • Demographics: 10 males, 10 females. 13 subjects

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The North-vision Elegant-1000 Series of Multi-parameter Patient Monitor are intended to monitor, display and record physiological signs of adult, pediatric patients. With the functions of near real-time recording and displaying parameters ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, it allows comprehensive analysis of patient's physiological conditions. This apparatus is applicable for use in hospitals, clinics, and practitioner's office. The operation should be carried out by qualified professionals only.

The Elegant-1000 Series are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. They are modular designed patient Monitors. They can monitor the patient's Electrocardiograph (ECG) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP) including systolic, diastolic and mean by oscillating method. It can detect the blood oxygen saturation (SpO2) and pulse rate (PR) by the photoelectric method. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.

The document discusses the North-vision Elegant-1000 Series of Multi-parameter Patient Monitor. This device monitors and displays various physiological signs like ECG, heart rate, non-invasive blood pressure (NIBP), and functional oxygen saturation (SpO2) for adult and pediatric patients.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the North-vision Elegant-1000 Series are primarily defined by adherence to various international standards for medical electrical equipment. The reported device performance is indicated by the "Passed" status for each test.

Additional Performance Specifications (Compared to Predicate Device for Equivalence):

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

The document states that clinical testing for NIBP and SpO2 functionality was completed to validate clinical accuracy. However, it does not specify the sample size used for this clinical test set for NIBP and SpO2, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective).

For the non-clinical tests, these typically involve lab-based testing of the device itself rather than patient data, so direct sample size for a "test set" in the context of patient data is not applicable.

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

The document mentions "clinical testing for conformance," which implies ground truth was established clinically. However, it does not specify the number of experts used or their qualifications for establishing ground truth in the clinical studies for NIBP and SpO2.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance compared to industry standards and general equivalence to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are primarily standalone performance studies of the device. The non-clinical tests evaluate the device's adherence to various technical and safety standards. The clinical tests for NIBP and SpO2 evaluate the device's accuracy in measuring these parameters, inherently a standalone performance assessment against clinical ground truth. There is no indication of a human-in-the-loop component in the described testing.

7. The Type of Ground Truth Used

For the NIBP and SpO2 clinical performance, the ground truth was implied to be clinical accuracy as determined by reference methods during the clinical testing for conformance with ANSI/AAMI 81060-2:2013 and ISO80601-2-61: 2011. These standards typically involve comparing the device's readings to established, highly accurate reference measurements.

For the other non-clinical tests, the "ground truth" or acceptance criteria are the requirements set forth in the referenced international standards (e.g., IEC, ISO, EN, ANSI/AAMI).

8. The Sample Size for the Training Set

The document describes pre-market notification for a medical device (patient monitor). This is typically a hardware and software system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here. The device's algorithms and underlying principles are likely based on established physiological measurement techniques, not on iterative learning from a large dataset.

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

As explained in point 8, the concept of a "training set" in the context of AI/ML is not applicable to this device's description. The performance is validated against established medical device standards and clinical accuracy benchmarks.

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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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Datalys Multi-Parameter Patient Monitor 750, 760, 780 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be the user from the monitor.

The monitor models monitor parameters such as ECG (3-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.

The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.

The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

The device has not been tested for and it is not intended for pediatric use.

Not Found

This document is an FDA 510(k) clearance letter for the Datalys Multi-parameter Patient Monitor 750, 760, 780. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information based on the given input. The document primarily focuses on regulatory approval and indications for use.

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Comen Multi-Parameter Patient Monitor models C50, C60, C80 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be made available to the user from the monitor.

The monitor models monitor parameters such as ECG (3-lead, 5-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.

The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.

The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

COMEN Multi-Parameter Patient Monitor Models C50, C60 and C80 obtain and display physiological data of the patient including waveforms and numerical data in real time. COMEN C series can be custom confiqured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), respiration (RESP) or temperature (TEMP). These physiological signals are converted into digital data and displayed.

For each parameter, COMEN C series examine the data for alarm conditions and present them on the display. COMEN C series have audio alarming function that may raise the user's attention of system error or as dictated by the physiological parameter settings.

COMEN C series are capable of storing data trends for retrospective review and sending serial port signal to printer for report printing.

Here's an analysis of the provided 510(k) summary regarding the COMEN Multi-Parameter Patient Monitor (K112877) and its acceptance criteria and study information:

Based on the provided document, the device is a multi-parameter patient monitor. The summary emphasizes that the device is deemed "substantially equivalent" to predicate devices, which implies that its performance is expected to be similar or within acceptable ranges of previously cleared devices. However, the document does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages or error margins) for each physiological parameter, nor does it provide a table of reported device performance against such criteria. Instead, it refers to compliance with various international standards as the basis for proving safety and effectiveness.

Here's the breakdown of the requested information:

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

As mentioned above, the document does not explicitly list specific numerical acceptance criteria or a table of device performance. Instead, it relies on compliance with various international standards, which inherently contain their own performance and safety requirements. The document states:

• "COMEN C series meet the following standards: IEC 60601-1-2, IEC 60601-2-30, IEC 60601-2-27, EN1060-1, EN1060-3, EN1060-4, EN60601-2-49, EN 60601-1, AAMI EC13, ISO10993-1, ASTM E1112-00, ISO 9919, ISO 80601-2-56."

Meeting these standards would mean the device implicitly meets the performance and safety criteria outlined within each respective standard for various parameters (ECG, NIBP, SpO2, Respiration, Temperature). For example:
* IEC 60601-2-27: Specific requirements for the safety and essential performance of electrocardiographic monitoring equipment.
* EN1060-1, EN1060-3, EN1060-4: Non-invasive sphygmomanometers (blood pressure monitors).
* ISO 9919 / ISO 80601-2-61 (relevant for SpO2, although ISO 9919 is older): Requirements for pulse oximeter equipment.
* AAMI EC13: Cardiac monitors.
* ASTM E1112-00: Electronic thermometers.

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

The document does not provide information on sample sizes for test sets or data provenance. It states: "A risk analysis of the system and its software was performed and testing was conducted to validate the systems overall operation." This implies internal testing but no specific details are given about the subjects or data.

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)

The document does not mention the use of experts or ground truth establishment in the context of a specific test set. The validation is primarily based on compliance with international standards through non-clinical testing.

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

The document does not describe any adjudication method for a test set, as no dedicated clinical test set is elaborated upon.

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

No MRMC comparative effectiveness study was done or mentioned. This device is a diagnostic/monitoring tool, not an AI-assisted interpretation system for 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. The "testing was conducted to validate the systems overall operation" refers to its standalone performance in accordance with the listed standards. However, the document does not explicitly detail specific "algorithm only" performance data separate from the overall system validation based on standards compliance.

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

For the non-clinical tests performed, the "ground truth" would be the reference values or established methodologies defined within each of the international standards (e.g., standard blood pressure cuffs for NIBP accuracy checks, calibrated temperature probes for TEMP accuracy, defined ECG signals for ECG performance). No clinical ground truth (like pathology or outcomes data) is mentioned as the basis for testing.

8. The sample size for the training set

The document does not mention any training set or associated sample size. This type of device (a multi-parameter patient monitor) typically relies on engineering design, calibration, and validation against established physiological signal processing principles and standard test procedures outlined in the relevant IEC/ISO standards, rather than machine learning training sets.

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

As no training set is mentioned, this information is not applicable and not provided.

Summary of Key Takeaways from the document K112877:

• Acceptance Criteria: Based on adherence to a comprehensive list of international safety and performance standards (e.g., IEC 60601 series, EN1060 series, AAMI EC13, ASTM E1112-00, ISO 9919, ISO 80601-2-56). Specific numerical performance data against these criteria is not detailed in the summary.
• Study Type: Non-clinical bench testing and risk analysis to demonstrate compliance with the listed standards and overall system operation validation.
• No Clinical Studies: The summary explicitly states "Discussion on Clinical Tests Performed: Not Applicable." This means no human subject trials or clinical performance evaluations were conducted or provided in this 510(k) submission to assess the device's accuracy or effectiveness in a patient population.
• Ground Truth: For non-clinical testing, ground truth would be established by the physical or simulated reference values and methods specified within the compliance standards.
• No AI/Machine Learning Aspects: The device is a traditional multi-parameter patient monitor, and there is no indication of AI, machine learning, training sets, or comparative effectiveness studies involving human readers and AI assistance.

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PMS8210A Model Code 500 is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Model Code 500 has certain features and functions.

The patient parameters that can be monitored by PMS8210A Model Code 500 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), Temperature (TEMP) and End-tidal CO2 (EtCO2) . 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 Model Code 500 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 Model Code 500 is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.

PMS8210A Model Code 500 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), End-tidal (etCO₂). 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 submitted device is the same as the predicate with two differences. The new model has added an etCO2 function and the Temp module has been changed. The new Temp module is a previously FDA cleared device.

The provided text describes a 510(k) premarket notification for the PMS8210A (IRIS) Multi-Parameter Patient Monitor Model Code 500. This device is a multi-parameter patient monitor intended for use in healthcare facility settings.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various standards and directives to which the device conforms, indicating these as the acceptance criteria. The device's performance is reported as meeting these standards, implying "Same" as the predicate device or conforming to the specified standards without providing specific numerical performance data within the summary itself.

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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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