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This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, pulse rate (PR), noninvasive blood pressure (NIBP), functional oxygen saturation (SpOz), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO2), it allows comprehensive analysis of patient's physiological conditions.

This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

There are three versions of the K serial Patient Monitor, K10, K12 and K15. The primary difference is physical dimension and display TFT size; all other specifications remain unchanged. All versions have the same indications for use.

This document, a 510(k) summary for the Shenzhen Creative Industry Co., Ltd. Patient Monitor, Models K10, K12, and K15, primarily focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Creative Industry UP-7000 Patient Monitor, K123711) rather than detailing the specific acceptance criteria and study proving performance for a novel AI/software device.

Therefore, much of the requested information regarding AI device performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training) is not applicable or present in this document. This document describes a traditional medical device (patient monitor) and its components, and the "study" referred to is non-clinical and clinical testing to ensure compliance with relevant performance standards for vital sign monitoring.

However, I can extract the information that is applicable based on the provided text, particularly focusing on the performance criteria for the integrated vital sign modules.

Here's an analysis based on the provided text:

Device: Patient Monitor, Models K10, K12, K15

Indications for Use: Monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients, including ECG, heart rate (HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), and end-tidal CO2 concentration (EtCO2). Applicable for use in hospitals and clinical institutions, operation by qualified professionals only.

Study Type: This is a 510(k) submission seeking substantial equivalence to a predicate device. The "studies" involve non-clinical (safety and performance) and clinical (NIBP validation) testing against recognized standards rather than a comparative effectiveness study of a novel AI algorithm's diagnostic performance.

1. Table of acceptance criteria and the reported device performance:

The document lists performance specifications for each physiological parameter module, often directly comparing them to the predicate device. The acceptance criteria are implicitly that the devices meet or are substantially equivalent to the established performance requirements of the predicate device and relevant industry standards.

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The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.

The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE ONE:

The CARESCAPE ONE is not intended for use within a controlled MR environment.

CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).

CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).

CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station.

Here's an analysis of the acceptance criteria and supporting studies for the CARESCAPE ONE device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a direct table of specific acceptance criteria with corresponding performance values for all features. However, it does highlight performance claims and comparisons for key components, specifically arrhythmia detection and SpO2.

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

• Arrhythmia (EK-Pro V14): The document references ANSI/AAMI EC57:1998 (R)2012. This standard specifies databases (e.g., AHA, MIT-BIH) that are used for testing arrhythmia algorithms. The specific sample size from these databases used for EK-Pro V14 testing is not explicitly stated in this 510(k) summary, but it would be derived from the standard's requirements.
  • Data Provenance: The databases mentioned in EC57 are typically retrospective, internationally recognized ECG databases. The exact country of origin for the data used for this specific EK-Pro V14 validation is not specified, but the standard's databases often compile data from various global sources.
• SpO2 (TruSignal V3): The document states a "controlled desaturation study." The sample size is not explicitly stated in this summary.
  • Data Provenance: A controlled desaturation study is a prospective clinical study designed to test pulse oximeter accuracy. The country of origin for this study is not specified.

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

• Arrhythmia (EK-Pro V14): When using standard databases like those referenced by ANSI/AAMI EC57, the ground truth (arrhythmia annotations) is typically established by multiple, highly experienced cardiologists or cardiac electrophysiologists. The exact number and qualifications for the original annotation of the standard databases are not specified in this document, as the standard itself defines these.
• SpO2 (TruSignal V3): For controlled desaturation studies, the "ground truth" for SpO2 is provided by a CO-oximeter measurement, which itself is a highly accurate laboratory method for oxygen saturation. This is an objective measurement rather than expert consensus. Therefore, "experts" in the traditional sense for establishing ground truth are not directly applicable here.

4. Adjudication Method for the Test Set

• Arrhythmia (EK-Pro V14): For standard databases, ground truth annotation often involves multiple experts reviewing and adjudicating discrepancies, sometimes with a "majority rules" or senior expert decision process. The specific adjudication method for the creation of the databases referenced by EC57 is not detailed in this summary, but would adhere to the methodologies defined by the creators of those databases.
• SpO2 (TruSignal V3): As the ground truth comes from CO-oximetry, an objective measurement, adjudication by experts is not applicable.

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

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This indicates that human-in-the-loop performance with or without AI assistance was not assessed in this submission for primary equivalence.

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

• Yes, standalone performance was assessed for key algorithms:
  • EK-Pro V14 Arrhythmia Detection algorithm: Its performance was evaluated against the ANSI/AAMI EC57 standard, comparing it to the predicate's EK-Pro V13 algorithm. This is a standalone algorithm performance evaluation.
  • TruSignal V3 SpO2 algorithm: Its accuracy was validated in a controlled desaturation study against CO-oximetry. This is also a standalone algorithm performance evaluation.

7. The Type of Ground Truth Used

• Arrhythmia (EK-Pro V14): The ground truth would be expert consensus annotations of ECG waveforms from standard arrhythmia databases (e.g., those specified in ANSI/AAMI EC57).
• SpO2 (TruSignal V3): The ground truth was objective laboratory measurement using CO-oximetry in a controlled study. This is considered a gold standard for blood oxygen saturation.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for training the EK-Pro V14 arrhythmia detection algorithm or the TruSignal V3 SpO2 algorithm. In 510(k) submissions, training set details (especially for existing, updated algorithms) are often not required to be as extensively disclosed as test set performance, particularly when demonstrating equivalence to a predicate.

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

• The document does not explicitly state how the ground truth for the training sets of the EK-Pro V14 or TruSignal V3 SpO2 algorithms was established. For complex algorithms like these, training data is typically meticulously annotated by a combination of clinical experts (for arrhythmia) or using highly accurate reference methods (for SpO2) and then verified. Again, in a 510(k) for an updated algorithm or component, the full developmental history and training data specifics may not be detailed if the focus is on demonstrating equivalent performance post-modifications.

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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 Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.

The Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.

This device is used to monitor up to four physiological parameters for the patient at the same time: End tidal CO2 concentration (EtCO2), Respiration Rate (RR), functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The monitor can be purchased having functions with two or more of the parameters mentioned above, but the manual can be used for the device in any configuration.

The Capno-H uses an infrared absorption method to measure in a sidestream or Mainstream mode. The measurement parameters are EtCO2, InsCO2 and Respiration Rate. InsCO₂, also called FiO₂ is the fraction of oxygen in the volume being measured. The CO2 response time is Sidestream:

The provided text describes the acceptance criteria and study for the CMI Health Inc. Capnograph and Oximeter, Model Capno-H (K170820).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are primarily based on equivalence to a predicate device (Shenzhen Creative Industry Co., Ltd, Vital Signs Monitor, Model PC-900A, K093016) and compliance with various international standards. The document explicitly states: "All of the pre-determined acceptance criteria were met."

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

The document does not specify human clinical trials or a "test set" in the context of diagnostic accuracy for the entire device. The performance data for SpO2 and CO2 accuracy are stated as ranges and thresholds without detailing specific patient data used for testing.

• SpO2 module: The document states that the Capno-H uses the "PC-60 SpO2 module cleared in K063641" and that "the sensors were clinically validated and intended to be used in K063641." This implies that the clinical validation for SpO2 accuracy was conducted as part of the K063641 submission, not for the current device directly. The provenance of that original SpO2 clinical validation data (K063641) is not provided in this document.
• CO2 module: The CO2 accuracy is presented as fixed ranges (e.g., ±2mmHg for 0-40mmHg). It mentions compliance with ISO 80601-2-55 (which governs respiratory gas monitors) and that the CO2 module (CapnoCore) uses the non-dispersive infrared gas (NDIR) technology. However, no specific details about a clinical test set (sample size, provenance) for CO2 accuracy are provided in this document for either the Capno-H or its CapnoCore module.
• Type of Study: The primary "study" described is a comparison to a predicate device and compliance with established performance and safety standards. This is a bench and engineering testing-based assessment rather than a typical clinical study with a specified "test set" of patients.

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

Not applicable. The document does not describe a clinical study where experts established ground truth for a test set. The accuracy claims are numerical specifications that are likely verified through device calibration and bench testing against known gas concentrations or established reference devices/methods for SpO2.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication is 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. This device is an oximeter and capnograph, not an AI-powered diagnostic imaging device involving human readers or interpretation of complex medical cases.

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

This device appears to be a standalone measurement device. Its performance specifications (e.g., SpO2 accuracy, EtCO2 accuracy) are inherently "standalone" in that they describe the device's direct measurement capability, without an AI component or complex human-in-the-loop interaction in its core function of displaying vital signs. The device is intended for "regular supervision of clinical personnel," but this refers to its clinical use, not the intrinsic performance validation of the measurement algorithms.

7. The Type of Ground Truth Used

The ground truth for the performance specifications (EtCO2, SpO2, Pulse Rate, Respiration Rate) would have been established using:

• Reference Standards/Known Concentrations: For CO2 accuracy, gas mixtures with precisely known CO2 concentrations would be used in bench testing.
• Reference Oximeters/Co-oximeters: For SpO2 accuracy, reference co-oximeters are typically used (e.g., during induced hypoxia studies) to establish arterial oxygen saturation (SaO2) values for comparison. The document clearly refers to "clinically validated" sensors in the SpO2 module (from K063641), implying such studies occurred for that module.
• Controlled Measurements: For pulse rate and respiration rate, comparison with ECG or manual counts, or simulated physiological signals, would likely be the ground truth.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical device, not an AI/machine learning algorithm that requires a "training set." The device's algorithms for calculating SpO2, CO2, etc., are based on established physiological principles and signal processing, not on training data in the AI sense.

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

Not applicable, as there is no "training set" for an AI algorithm.

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NTID is a handheld vital signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only . The unit transfers history data to PC through a USB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.

NTID Vital Signs Monitor provides:

• SpO2 monitoring
• Pulse rate (PR) monitoring
• End tidal carbon dioxide (EtCO2) monitoring
• Respiration rate (RR) monitoring
• CO2 and SpO2 waveform display
• Audible and visual physiological and technical alarms
• Trend graph and trend table review
• Alarm event records review
• History data storage
• Rechargeable batteries
• External power supply and charger
  The monitor is intended for monitoring adult and pediatric patients in clinical environments where healthcare is provided by healthcare professionals.
  The product is composed of monitor, SpO2 sensor, Mainstream/Sidestream CO2 sensor, charging base, USB Adapter and PC software.

Here's a breakdown of the acceptance criteria and the study details for the NT1D Vital Signs Monitor, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific accuracy criteria for SpO2, Pulse Rate, and EtCO2.

Note: For SpO2 accuracy per decade (70-80%, 80-90%, 90-100%), the NT1D also reports +/- 2%, aligning with its overall 70-100% accuracy claim. The predicate devices did not specify accuracy in these discrete ranges.

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

• SpO2 Module (Clinical Trial for T400A sensor):

  • Sample Size: Ten healthy volunteers.
  • Data Provenance: Prospective, from the Hypoxia Research Laboratory, University of California, San Francisco, USA.

• CO2 Module: The document states that the CO2 module has already obtained 510(k) numbers (K042601 for Capnostat 5 CO2 Sensor and K053174 for LoFlo C5 CO2 Sensor). This implies that the performance of the CO2 module within the NT1D is based on the previously established performance and clearance of these predicate CO2 sensors. Therefore, a new specific clinical test set for the CO2 module with the NT1D is not detailed, as its equivalence is established through the cleared components.

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

The document describes an invasive laboratory test for SpO2 accuracy. For such tests, the "ground truth" for oxygen saturation is typically established using a co-oximeter on arterial blood samples, which is considered the gold standard.

• The study was conducted in a "Hypoxia Research Laboratory."
• While the document doesn't explicitly state the number or qualifications of clinicians involved in sample collection or co-oximeter operation, such laboratory tests are generally performed by trained medical and/or laboratory professionals with expertise in invasive blood gas analysis and co-oximetry, ensuring the accurate establishment of the ground truth. The mention of "co-oximeter sample value" confirms this method.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for these types of clinical performance tests.

• For the SpO2 accuracy study, the performance is assessed by comparing the device readings against the co-oximeter reference values obtained from arterial blood samples. There isn't a subjective interpretation by multiple experts that would require an adjudication method like 2+1 or 3+1. The process is a direct comparison of quantitative measurements.

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 study was done. This device is a vital signs monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data alongside an AI. The evaluation focuses on the device's accuracy in measuring physiological parameters (SpO2, PR, EtCO2, RR).

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

• Yes, a standalone performance evaluation was done. The clinical trial for the SpO2 module (with the T400A sensor) and the reliance on previously cleared CO2 modules represent standalone performance evaluations. The device's measurement outputs are directly compared to a reference standard (co-oximeter for SpO2, and the previously established accuracy of the predicate CO2 sensors). Human interaction is for device operation and data collection, not for interpretation that influences the device's core measurement output.

7. The Type of Ground Truth Used

• For SpO2: Invasive laboratory testing (in vivo) using co-oximetry on arterial blood samples, which is considered the gold standard for SpO2 measurement.
• For CO2: Ground truth for the CO2 sensors (Capnostat 5 and LoFlo C5) would have been established during their initial 510(k) clearances, likely through comparison to reference gas analyzers or other established methods for CO2 measurement in controlled environments.

8. The Sample Size for the Training Set

• The document does not specify a training set size because this device is a vital signs monitor based on established spectrophotometry (SpO2) and infrared absorption (CO2) principles, not a machine learning or AI-driven algorithm that typically requires a large training dataset. The "training" for such devices is inherent in their physics-based design and calibration.

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

• As mentioned above, there is no explicit "training set" in the context of machine learning. The device's design and calibration are based on fundamental scientific principles and established measurement techniques.
  • For SpO2, the underlying principles of differential light absorption by oxyhemoglobin and deoxyhemoglobin are well-understood and form the basis of the device's algorithms. Calibration would involve using known oxygen concentrations.
  • For CO2, the principle of infrared absorption by CO2 molecules is used. Calibration would involve using gas mixtures with known CO2 concentrations.

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The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended for use by healthcare professionals.

The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) provide monitoring for the following vital sign parameters: ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, carbon dioxide (CO2).

The modified device, the Expression MR200 MRI Patient Monitoring System, is predicated from the MRI Patient Monitoring System (Model 865214) that received clearance to market under 510(k) K090785 on December 15, 2009. The modified device, the Expression IP5 Information Portal is predicated from the Expression Information Portal that received clearance to market under 510(k) K121424 on June 13, 2012. The Expression IP5 is a supplement to the Expression MR200 display; together they comprise a medical system. The Expression MR200 incorporates the same indications for use and fundamental scientific technology used in the cleared device, the MRI Patient Monitoring System (Model 865214). As such, the modified Expression MR200 MRI Patient Monitoring System is substantially equivalent to the cleared device. The Expression IP5 incorporates the same indications for use and fundamental scientific technology used in the cleared device, the Expression Information Portal. As such, the Expression IP5 is substantially equivalent to the cleared device.

The cleared MRI Patient Monitoring System (Model 865214) consists of a processing unit within a Cart, a detachable wireless display, wireless ECG module, and wireless SpO2 module. The cleared device communicates wirelessly with the Expression IP5. The Expression IP5 is a supplement or alternate for the MRI Patient Monitoring System (Model 865214) display. The Expression IP5 does not perform any data collection or processing as a stand-alone patient monitoring system. The Expression IP5 relies upon the MRI Patient Monitoring System (Model 865214) processing unit, wireless modules, and patient applied parts to complete data collection and processing. Identical to the cleared device, the Expression MR200 is capable of operating from AC mains or battery power and the wireless modules operate on battery power only. The modified device, the Expression MR200 MRI Patient Monitoring System, is structurally identical to the cleared device with the exception of the following:

• The Expression MR200 power supply is built into the Cart (rather than a separate external power converter connected to the Cart via power cord).
• The Expression MR200 display is not detachable from the Cart. Subsequently, the carrying handle has been removed from the permanent display and the transmission of information between the Cart and the MR200 display is not wireless.
• The speaker is located on the top rear of the Cart display (rather than the front of the display).
• The Alarms Setup, Printer Setup, and Monitor Setup functions are collapsed within one Setup key on the keypad which is visible to the operator at all times (rather than separate keys for each Setup function). This feature is identical to the cleared Expression IP5.
• The alarm light located on the top of the display is removed. (Other visual alarm indicators consistent with IEC 60601-1-8, error messages, and audible alarms are still provided on the modified display, identical to the cleared device. Note that the alarm light is an optional visual indication per IEC 60601-1-8.)
• A printer option is not offered in the Expression MR200 display. (The printer is provided as separate USB-connected peripheral equipment to the Expression IP5, identical to the cleared Expression IP5.)
• The NiBP and CO2 connector ports on the Expression MR200 Cart are revised slightly to accommodate the new unique connectors.
• The mechanical aesthetic design of the Cart was made consistent with other patient monitoring devices distributed by Philips Medical Systems.

The modified Expression IP5 is a supplement to the Expression MR200 display. Identical to the cleared device, the Expression IP5 operates on AC mains power only. Identical to the cleared devices, communication between the Expression MR200 and the Expression IP5 is wireless and the Expression IP5 relies upon the Expression MR200 processing unit, wireless modules, and patient applied parts to complete data collection and processing.

The cleared device provides patient monitoring data for ECG, pulse oximetry (SpO2), respiration, non-invasive blood pressure (NiBP), invasive blood pressure (IBP), temperature, oxygen (O2), end-tidal carbon dioxide (CO2), and anesthetic agents. The cleared device is capable of providing the patient's pulse rate data derived from ECG, SpO2, or NiBP. The modified device, the Expression MR200, employs the same parameters as those cleared to market in 510(k) K090785 with the exception of invasive blood pressure, temperature, oxygen, and anesthetic agents. The modified device is capable of providing the patient's pulse rate data derived from ECG or SpO2 only; NiBP-derived pulse rate is not provided in the modified device. The cleared and modified devices are intended for the neonatal. pediatric, and adult patient populations. The cleared and modified devices provide user-adjustable alarms which are generated by the patient monitoring system display and the Expression IP5 display.

The wireless ECG module collects all ECG data, performs most of the ECG gradient filtering, and transmits the data to the processing unit within the Expression MR200 Cart. Additional ECG filtering, data processing, and heart rate derivation is performed in the Expression MR200 Cart. The modified device incorporates the same wireless ECG module, ECG processor in the Cart, and electrodes that are currently used with the cleared device. All ECG patient cables are identical to those cleared to market with the MRI Patient Monitoring System (Model 865214), with the exception of the Advanced Filter ECG Cable. The ECG leads on the Advanced Filter ECG Cable have been lengthened from 5 inches to 11 inches for improved performance during Vectorcardiography (VCG) applications when providing signals for synchronization for the MRI scanner. The cable trunk design that includes the resistance and insulation, the connector. and the electrode clips are identical to the cleared device. The modified device has the same intended use, indications for use, performance specifications, and labeling as the cleared device regarding ECG.

The cleared device's SpO2 patient data is obtained from the wireless SpO2 module. The wireless SpO2 module collects and processes all SpO2 and bellowsderived respiration data and transmits the data to the processing unit within the cleared device's Cart. Identical to the cleared device, the modified device's SpO2 patient data is obtained from the cleared wireless SpO2 module. The wireless SpO2 module collects and processes all SpO2 and bellows-derived respiration data and transmits the data to the processing unit within the modified device's Cart. The modified device incorporates the same wireless SpO2 module, fiber optic sensor, clips, and grips that are currently used with the cleared device. Therefore, the modified device has the same intended use, indications for use, performance specifications, and labeling as the cleared device regarding SpO2.

The cleared device's NiBP patient data is collected and measured in the processing unit within the Cart. Identical to the cleared device, NiBP data collection and measurement is performed in the modified device's processing unit within the Cart. However, in the modified device, the NiBP data collection and measurement is completed using the picoNBP OEM module that was cleared to market in 510(k) K051366 on September 14, 2005. The picoNBP OEM module is a complete non-invasive arterial blood pressure measurement unit that incorporates all hardware control and signal processing and the algorithms to derive systolic, diastolic, and mean blood pressure. The derived data is provided to the Expression MR200 MRI Patient Monitoring System.

The cleared device's CO2 patient data is collected and measured in the processing unit within the Cart. Identical to the cleared device, inspired and end-tidal CO2 data collection and measurement is performed in the modified device's processing unit within the Cart. However, in the modified device, the CO2 data collection and measurement is completed using the LoFlo C5 CO2 sensor that was cleared to market in 510(k) K053174 on January 12, 2006.

The cleared device's respiration patient data is bellows-derived from the SpO2 measurement. The modified device's respiration patient data can be bellowsderived from the SpO2 measurement, identical to the cleared device, or derived from the CO2 measurement.

The cleared device's processing unit transmits the patient data and power/communication status to the detachable display and the Expression IP5 using telemetry. Identical to the cleared device, the modified device's processing unit transmits the patient data and power/communication status to the Expression IP5 using telemetry. However, the modified device's processing unit transmits the patient data and power/communication status to the Expression MR200 immovable display using a wired connection. In the cleared and modified devices, all data and status transmission occurs simultaneously using a transceiver and antenna that support bi-directional 2.4 GHz wireless communication and operate within the frequency band reserved for industrial, scientific, and medical (ISM) equipment.

The cleared device's detachable display and the modified device's permanent display incorporate an LCD display for viewing, and keypad and rotary knob for navigation. When located within the MR control, induction, or recovery rooms, the cleared device's detachable display may provide data output to the Hospital Information System (HIS) in ASCII character format via connection to a thirdparty serial-to-Ethernet adapter wired to the RS232 port on the rear of the display. In addition, the cleared device may provide data output to the HIS in HL7 format via a standard Ethernet connection on the cleared Expression IP5. The modified device, the Expression MR200, does not provide HIS-interface data output directly from the Expression MR200. However, the Expression MR200 may provide HIS-interface data output via the modified Expression IP5 in a manner identical to the cleared device. The cleared and modified Expression IP5s provide data output to the HIS in HL7 format, compliant to HL7 Messaging Standard Version 2.6. No data is input from the HIS to the cleared or modified devices. The cleared and modified Expression IP5 Information Portals employ a touchscreen LCD display.

This document describes the 510(k) summary for the Expression MR200 MRI Patient Monitoring System and Expression IP5 Information Portal. This is a submission for modifications to a previously cleared device, not a new device. Therefore, the "acceptance criteria" discussed are primarily compliance with various standards and verification/validation activities to demonstrate that the modifications do not negatively impact safety and effectiveness and that the modified device remains substantially equivalent to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification submission for a patient monitoring system, the acceptance criteria are not typically expressed as specific performance metrics in a table like one would see for a diagnostic device. Instead, they are framed as compliance with recognized standards and successful verification/validation of design changes. The document repeatedly states that the device "complies with the applicable requirements of these standards" and "operates as intended within the performance specifications."

Here's a summary of the types of "acceptance criteria" and the reported "performance" based on the provided text, focusing on the changes and how their performance was validated:

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

• Test Set Sample Size: The document does not specify a "test set" in terms of patient data or clinical samples for a performance study. This submission is for modifications to an existing device, focusing on engineering verification and validation against standards and specifications. The "sample" would entail the physical product (e.g., modified ECG cables, new NiBP hoses, specific CO2 sensors) and the modified system itself undergoing various engineering and laboratory tests.
• Data Provenance: The document does not mention the country of origin of data or whether it was retrospective or prospective, as it relies on engineering testing and compliance with standards rather than clinical data from human subjects.

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

This information is not applicable. The device relies on compliance with established national and international standards and verification of engineering requirements, not on expert consensus on clinical ground truth. For components like the CO2 sensor and NiBP module, vendor verification data was reviewed.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical study involving human judgment or adjudication. The "adjudication" was effectively through compliance with pre-defined engineering specifications and national/international standards via laboratory testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This device is a patient monitoring system, not a diagnostic imaging or interpretation aid, and the submission focuses on engineering modifications and regulatory compliance. Therefore, comparative effectiveness with or without AI assistance for human readers is not relevant to this submission.

6. Standalone Performance Study (Algorithm Only)

This information is not explicitly detailed as a distinct "standalone" study in the context of an "algorithm only" performance. The product is a physical patient monitoring system. However, the document does state that the new NiBP module (picoNBP OEM module) incorporates "all hardware control and signal processing and the algorithms to derive systolic, diastolic, and mean blood pressure," and the CO2 sensor (LoFlo C5 CO2 sensor) was also evaluated. The "performance specifications" for the entire system were verified and validated, meaning the internal algorithms' output (e.g., derived heart rate, SpO2, blood pressure values) met the required accuracy and reliability against reference standards during testing. There's no specific "algorithm-only" study separated from the device's integrated function.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation studies described would be:

• Reference Standards: Measurements from calibrated reference equipment conforming to national and international standards (e.g., for ECG, SpO2, NiBP, CO2 accuracy).
• Regulatory Standards: Compliance with specific clauses and requirements of standards like IEC 60601 series, ISO 80601 series, ASTM standards, FCC regulations, etc.
• Design Specifications: The internal performance specifications defined by Invivo Corporation based on market needs, risk management, and intended use.

8. Sample Size for the Training Set

This information is not applicable. This submission describes modifications to a patient monitoring system, which does not involve a "training set" in the context of machine learning or AI models. The device's underlying technology relies on established physiological measurement principles and signal processing, not data-driven (AI) training.

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

This information is not applicable, as there is no "training set" for this device.

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The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric a nd neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

The YM6000 patient monitor is to monitor electrocardiography (ECG), Arrhythmia, ST segment, heart rate (HR), pulse rate, noninyasive blood pressure (systolic, diastolic and mean arterial pressures); functional arterial oxyge n saturation, invasive b lood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate in patients in general hospital and alternate ca re facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The YM6000 patient monitor is a lightweight and compact device (341 × 305 × 172 (mm) (W × H × D) and 5.5 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

The provided text is a 510(k) summary for a patient monitor. It focuses on establishing substantial equivalence to predicate devices rather than presenting detailed performance studies with specific acceptance criteria and detailed study results in the format requested.

Therefore, many of the requested categories cannot be directly extracted from the provided text. The document primarily describes the device, its intended use, and argues for its equivalence based on shared modules and compliance with industry standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance values in a quantifiable manner for each parameter. Instead, it states that various modules (ECG, NIBP, SpO2, Respiration, Thermometry, Capnography) used in the YM6000 are identical to those in predicate devices and comply with relevant standards (AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34). For example, it says: "all devices comply with the AAMI performance standard SP-10 & IEC60601-2-30 and have same measurement technology" for NIBP.

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

This information is not explicitly stated in the document. The text mentions "The Mediana patient monitor, Model YM6000 substantially have been tested in accordance with the system V & V plan (#P AA00-00005) and summary included with the submission using production equivalent units prior to release to market." This indicates testing was performed, but details about sample size, data type (retrospective/prospective), or origin are not provided.

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)

This information is not provided. The document focuses on technical equivalence and compliance with standards rather than human-expert-based ground truth establishment.

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

This information is not provided.

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 is not an AI-powered device, but a physiological patient monitor. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

The device is a patient monitor. Its performance is inherent to its functional modules, which operate "standalone" in recording physiological parameters. The document primarily focuses on the technical specifications and standards compliance of these modules.

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

The "ground truth" for a patient monitor like the YM6000 would generally be based on:

• Reference measurement devices/standards: For parameters like NIBP, SpO2, ECG, etc., the accuracy is typically verified against highly accurate reference devices or simulated signals that meet specific industry standards.
• Compliance with performance standards: The document frequently refers to compliance with standards like AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34. These standards define the acceptable range of error and performance characteristics.

The document does not explicitly state "expert consensus," "pathology," or "outcomes data" as ground truth methods for the device's fundamental physiological measurements.

8. The sample size for the training set

This information is not provided. For a patient monitor, there isn't typically a "training set" in the machine learning sense. The device's algorithms for physiological parameter measurement are developed based on established physiological principles and signal processing, and then validated against a range of inputs/patients.

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

As there's no mention of a "training set" in the AI/machine learning context, this question is not applicable. The ground truth for developing and testing the device's measurement algorithms would be based on established medical and engineering principles, known physiological ranges, and comparison with highly accurate reference equipment under controlled conditions.

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The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring:

• Electrocardiography (ECG)
• Heart rate (HR)
• Noninvasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Pulse rate (PR)
• Respiration rate (RR)
• Temperature (Temp)
• Arrhythmia/ST segment (M30 only)
• Capnography (M30 only)
  Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
  Note: The medically skilled and trained user can be clinicians like doctors and nurses who know to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.

The Mediana Lucon M-series (M20, M30) patient monitor is a lightweight and compact device (250 × 210 × 170 (mm) and 3.2 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

• Electrocardiography (ECG)
• Heart rate (HR)
• Noninvasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Pulse rate (PR)
• Respiration rate (RR)
• Temperature (Temp)
• Arrhythmia/ST segment (M30 only)
• Capnography (M30 only)

The provided text does not contain specific acceptance criteria with numerical performance targets or a detailed study demonstrating that the device meets these criteria. Instead, it focuses on establishing substantial equivalence to predicate devices for a patient monitor (Mediana Lucon M-series M20, M30).

However, based on the information provided, we can infer the approach used to demonstrate performance and substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance specifications of the predicate devices. The document repeatedly states that the Mediana Lucon M-series has "identical" or "similar" specifications and uses "identical technology" or "same technology" as the predicate devices. It also mentions compliance with relevant performance standards.

• ECG and heart rate specifications are identical to Omron HBP-2070.
• ECG measurement performance is similar to Philips SureSigns VM6.
• Uses identical technology as predicate devices. |
  | Noninvasive Blood Pressure (NIBP) | - NIBP module (M3200) is identical to that in Omron HBP-2070.
• NIBP specifications are identical to Omron HBP-2070.
• Complies with AAMI performance standard SP-10 & IEC60601-2-30.
• Uses same technology as predicate devices (Omron HBP-2070 and Philips SureSigns VM6). |
  | Functional Arterial Oxygen Saturation (SpO2) | - SpO2 module (NELL-3) is used in Spacelabs mCARE 300, 91220 and Omron HBP-2070.
• SpO2 specifications are identical to Omron HBP-2070 and Spacelabs 91220.
• Complies with performance standard ISO9919. |
  | Respiration Rate (RR) | - Algorithm of Impedance measurement is identical to Omron HBP-2070.
• Respiration specification is identical to Omron HBP-2070.
• Respiration measurement (Thoracic Impedance) for Lucon M-series and Spacelabs 91220 are from the same ECG module (designed and manufactured by Mediana). |
  | Capnography (EtCO2) | - Algorithm of Airway Measurement has identical performance to Spacelabs 91220.
• Airway Measurement is from Capnography module (Philips Respironics Inc.).
• Operation theory of Airway Measurement in Welch Allyn Propaq Encore 200 series is same as Lucon M-series (M30 only) and Spacelabs 91220.
• Uses Capnostat 5 and Lo Flo C5 modules (already FDA registered: K042601, K053174) which are identical to modules used in Spacelabs 91220.
• Minor differences in Capnography specification between Lucon M-series (M30 only) and identified predicate devices; all three devices have identical technology and operation theory for Capnography. |
  | Temperature (Temp) | - Thermometry MDT-1 module is identical to that in Omron HBP-2070 and Spacelabs 91220.
• Temperature measurement technology is equivalent to Omron HBP-2070 and Spacelab 91220.
• Uses YSI 400 and 700 probes/probe covers, identical to predicate devices. |
  | Pulse Rate (PR) | - Derived from NIBP channel (M3200 module), identical to Omron HBP-2070.
• Derived from SpO2 channel (NELL-3 module), identical to Omron HBP-2070 and Spacelabs 91220. |
  | General Device Functionality | - Internal power source (rechargeable lead acid battery and AC power) is similar to predicate devices.
• Overall safety and effectiveness, and compliance with appropriate medical device standards, stated to be substantially equivalent to predicate devices. |

Study Details:

The submission highlights a "Summary of Performance Testing" but provides very limited details about the actual studies conducted to prove the device meets acceptance criteria.

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

   • The document states that the device "substantially have been tested... with the system V & V plan (#MDR-YW071202-02) and summary included with the submission using production equivalent units prior to release to market."
   • No specific sample size for a test set is mentioned.
   • No information on data provenance (e.g., country of origin, retrospective or prospective) is provided. The testing seems to be internal verification and validation (V&V) against design specifications and predicate device performance.

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

   • Not applicable/Not mentioned. The testing described involves technical performance characteristics, not clinical interpretation that would require expert ground truth.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Given the nature of the technical performance testing described, an adjudication method like 2+1 or 3+1 would not be relevant.

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 MRMC study was done. This device is a patient monitor, not an AI-assisted diagnostic tool.

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

   • Yes, implicitly. The "Performance Testing" refers to the device's technical specifications and how it performs in measuring various physiological parameters. This would be standalone performance of the device's modules and algorithms. The core argument for substantial equivalence relies on the identical/similar technology and specifications to the predicate devices, which suggests an evaluation of the device's intrinsic measurement capabilities.

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

   • The ground truth for this type of device would typically be reference standards or highly accurate measurement equipment used to validate the accuracy and precision of each physiological parameter (ECG, NIBP, SpO2, Temp, RR, EtCO2). For example, NIBP accuracy might be validated against an invasive arterial line or a calibrated simulator. The document also mentions compliance with specific performance standards (e.g., AAMI SP-10, IEC60601-2-30, ISO9919), which define test methods and acceptance criteria.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to use a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physiological measurement technologies, often implemented as modules from reputable manufacturers (Omron, Nellcor, Philips Respironics).

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

   • Not applicable/Not mentioned. As there's no mention of a traditional training set for an AI algorithm, this question is not relevant. The performance is validated against established medical device standards and the performance of predicate devices.

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The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.

The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.

PC-900A vital signs monitor is a small Multi-parameter Patient Monitor, which can monitor the vital physiological parameters: Carbon Dioxide (CO2), Pulse Oxygen Saturation (SpO2), respiration and pulse rate. 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. The specific sensors have been previously cleared by the FDA 510(k) process. (For specifics, please refer to the Description Section). After CPU analyzing and calculating, the parameters can display on the screen in a graphical way, record and/or print if necessary. The alarm will work if the parameters over the limits to take medical practitioner's attention.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Vital Signs Monitor, Model PC-900A:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria for a new clinical trial. However, it does list performance specifications and accuracy claims for the device. These can be interpreted as the functional acceptance criteria the manufacturer aims for, by comparing them to predicate devices.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarmine of multiple physiological parameters of adults, pediatrics and memates in healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release D.02 software into the IntelliVue Patient Monitor devices, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90.

This 510(k) summary (K060221) describes the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Release D.02. This submission is for a software modification (Release D.02) to existing, legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly states that the performance criteria for the modified devices were based on the predicate devices and other previously cleared submissions. The testing showed "substantial equivalence." However, explicit numerical acceptance criteria for specific physiological parameters are not provided in this summary. Instead, the focus is on demonstrating that the new software release maintains the safety and effectiveness of the previously cleared devices.

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

• Sample Size: The document does not specify a numerical sample size for the test set used in "system level tests, performance tests, Pass/Fail tests, and safety testing."
• Data Provenance: Not specified. However, given that Philips Medizin Systeme Boeblingen GmbH (Germany) is the submitter, it is likely that parts of the testing were conducted in Germany. The nature of the testing (performance tests, safety tests) suggests a combination of simulated and possibly real-world data, but this is not explicitly stated. The study appears to be retrospective in the sense that it evaluates the new software's performance against existing benchmarks and predicate device performance, rather than a new, prospective clinical trial.

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

Not applicable. This submission is for a software modification to an existing device, focusing on demonstrating substantial equivalence to its predicate. The testing described (system level, performance, pass/fail, safety) would typically involve engineering and quality assurance personnel, not clinical experts establishing ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

Not applicable. The testing described does not involve human interpretation requiring adjudication. It's a technical verification of device functionality and performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI assists in that interpretation. The IntelliVue Patient Monitors are monitoring devices, and the submission is for a software update to ensure existing functionality is maintained.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The testing described (system level tests, performance tests, Pass/Fail tests, and safety testing from hardware and software analysis) is inherently a standalone assessment of the device's technical performance with the new software. It evaluates the algorithm and device's capabilities independent of a human operator's direct interpretation of the raw output for diagnostic purposes. The device is a "patient physiological monitor (with arrhythmia detection or alarms)," indicating algorithmic processing of physiological signals.

7. The Type of Ground Truth Used:

The ground truth for the performance tests would be based on:

• Known input signals: For performance and accuracy tests, the device would likely be fed known, precisely controlled physiological signals to verify its measurement accuracy, alarm thresholds, and data processing.
• Predicate device specifications: The performance of the modified device would be compared against the established specifications and performance characteristics of the legally marketed predicate devices.
• Safety standards: Compliance with relevant safety and electrical standards forms a critical part of the ground truth.

8. The Sample Size for the Training Set:

Not applicable. This document describes a software update for a physiological monitor, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" of the device's algorithms would have occurred during the development of the original predicate devices, if applicable.

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

Not applicable, as there is no mention of a "training set" in the context of this software update. The algorithms for physiological monitoring (e.g., arrhythmia detection, ST segment analysis) are typically based on established medical science and engineering principles, not statistical learning from a large, annotated training dataset for this type of device at the time of this submission (2006).

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