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The Portrait VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport.

The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.

The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.

The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients.

The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

The optional Welch Allyn® SureTemp® Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.

The optional Exergen TemporalScanner thermometer is intermittent measurement of human body temperature of patients of all ages.

The optional HeTaiDa electronic infrared non-touch thermometer is intermittent measurement of human body temperature of patients of all ages.

A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.

The portable device is designed for use in hospital-type facilities. The Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings.

The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner.

The Portrait VSM vital signs monitor is not intended for use during MRI.

"Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.

The proposed Portrait™ VSM is a vital signs monitor which is developed based on primary predicate vital signs monitor VC150(K133810) with integrated NIBP and SpO2 design from a secondary predicate monitor B105M (K213490) and provided additional non-contact infrared body temperature measurement option by supporting OEM thermometer (K171888) previously cleared by FDA.
In addition to the added non-contact infrared body thermometer, the proposed monitor Portrait™ VSM also offer several enhancements:
New hardware platform
Adopted equivalent NIBP design from B105M(K213490)
Adopted equivalent SpO2 design from B105M(K213490)
Compatible with Recorder B1X5-REC
Support Round Advisor in spot check mode
Support automatically screens brightness adjustment.
Improved Early Warning Score
Addtional alarm management enhancement.
Additional cybersecurity enhancement

The proposed monitor Portrait™ VSM adopts larger 10-inch LCD touch screen with improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate monitor VC150 (K133810) while maintaining the same primary function and operation.

As with the predicate Monitor VC150 (K133810), the proposed Portrait™ VSM is Vital Signs Monitor, utilizing an LCD display and can measure the most commonly used vital signs of patient: Non-invasive Blood Pressure (NIBP), Pulse Rate (PR), Temperature (Temp), and Pulse Oxygen Saturation (SpO2).

Same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM also has three choices for SpO2 include GE TruSignal™; Nellcor™ or Masimo SET® and temperature measurement from Exergen® TemporalScanner™, and Welch Allyn® SureTemp®.

Both the predicate monitor VC150 (K133810) and the proposed monitor Portrait™ VSM can be configured to be used for Spotchecking or for continuous morning, the device can send measured patients' data to EMR (Electronic Medical Record) system by interfacing to Hospital Information Systems (HIS) over a wired or wireless network.

Moreover, same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM can be powered by battery or AC, has a carrying handle and can be placed on a shelf or table or mounted in a variety of ways using a mounting plate located on the bottom of the monitor.

The provided document is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc. Portrait VSM vital signs monitor. It describes the device, its intended use, and a comparison to predicate devices, along with summaries of non-clinical and clinical testing.

However, the document explicitly states that "the proposed monitor Portrait™ VSM did not require clinical studies to support substantial equivalence." This means there is no detailed clinical study described in this document that proves the device meets specific acceptance criteria based on human-in-the-loop performance or expert-adjudicated ground truth, as would be expected for a complex AI/ML-driven device.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through bench testing, compliance with consensus standards, and verification of hardware/software functionality, electrical safety, usability, and environmental performance.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain a study with the specific elements you've asked for related to clinical performance verification with AI/ML and human readers.

However, I can extract the acceptance criteria (in terms of standards compliance and functional equivalence) and the reported performance from the non-clinical testing described.

Here's what can be extracted and what cannot be provided given the document's content:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Equivalence Claim)

Since no clinical study was required, the "acceptance criteria" for this device's submission are primarily based on demonstrating:

1. Functional Equivalence to legally marketed predicate devices.
2. Compliance with relevant electrical safety, EMC, usability, and performance standards for vital signs monitors.
3. Verification of hardware and software specifications through bench testing.

Therefore, the table below will reflect the claimed equivalence and standards compliance as the "performance" rather than specific accuracy metrics against a clinical ground truth from a reader study.

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The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (02), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements.

The bedside monitoring systems require both a core unit and an input unit. The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices.

The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display
• CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav

The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav
• CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display

The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

Here is an analysis of the acceptance criteria and supporting study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device rather than defining specific performance-based acceptance criteria for novel claims. The acceptance criteria are implicitly derived from the predicate device's specifications and compliance with recognized standards. Therefore, the "reported device performance" is essentially a statement of "identical" or "below" (meaning lower capacity/resolution but deemed not to affect safety/effectiveness) compared to the predicate.

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The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures.

The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.

The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).

The 3880 MRI Patient Monitoring System, also referred to as the 3880, cleared October 25th, 2017, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or attached to a patient bed. The 3880 provides monitoring for the following parameters:

• Electrocardiogram (ECG) ●
• Heart rate (HR- ECG, SpO2, and NIBP derived) ●
• Blood oxygen saturation/pulse oximetry (SpO2) ●
• Non-invasive blood pressure (NIBP)
• End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) ●
• Anesthetic agents (AGENTS) (requires 3886 Multi-Gas Unit) ●
  • Desflurane (DES) O
  • Enflurane (ENF) O
  • Halothane (HAL) O
  • Isoflurane (ISO) O
  • Sevoflurane (SEV) O
• Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiN2O) ● (requires 3886 Multi-Gas Unit)
• Temperature (TEMP) ●
• Respiration rate (CO2-derived) ●

The provided text describes a 510(k) premarket notification for the Iradimed Corporation's 3880 MRI Patient Monitoring System. The purpose of this submission is to expand the indications for use to include neonatal populations for Pulse Oximetry (SpO2), Capnography (CO2), and Anesthetic Agents (AGENTS). The manufacturer claims substantial equivalence to previously cleared devices.

Based on the provided text, the device itself is a patient monitoring system, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical and potentially clinical testing performed to demonstrate substantial equivalence for the expanded indications.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by conformance to FDA-recognized consensus standards for medical electrical equipment. The "reported device performance" is indicated by a "Pass" for each standard.

Notes from the document:

• *All FDA Recognized Consensus Standards test reports listed above were provided and reviewed with the primary predicate device, which was cleared to market under K172200. The test reports provided in this submission, identified with asterisks in the table above, have been supplied in Section 18 to support substantial equivalence with the parameter specific predicates for the SpO2 and CO2/AGENTS parameters.
• ** Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted to demonstrate equivalence of the subject device which integrates Masimo MS Series Module and sensor technology. The testing demonstrated equivalence of both systems when configured for use in neonates.

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

The document explicitly states: "The proposed modifications to the 3880 MRI Patient Monitoring Systems labeling does not require non-clinical performance testing. The non-clinical performance testing provided in K172200 has not changed since the submission and is still applicable to the modified device."

• Sample Size for Test Set: Not directly specified in the provided text for the current submission (K180903). The reliance is on prior testing from K172200 and the specified predicate devices (K050399, K053269, K171121). For the SpO2 performance, "The SpO2 volunteer blood study testing results using ISO 80601-2-61:2011 were submitted with K172200." This suggests human subject data for SpO2 accuracy, but the sample size is not stated here. "Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted" for neonatal SpO2, but again, the sample size (e.g., number of test points, subjects) is not provided.
• Data Provenance: The data is primarily from non-clinical performance testing (bench testing) and possibly a volunteer blood study. The origin (country, retrospective/prospective) of this data is not specified, but typically, premarket testing for FDA clearance is conducted under good laboratory practices (GLP) and may involve international standards but is intended for the US regulatory context. The nature of the submission (510(k) for an expanded indication) suggests this isn't a large-scale clinical trial with geographical data.

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

This type of information is typically relevant for studies involving subjective interpretations (e.g., image analysis for AI diagnostic devices). For a vital signs monitor, the "ground truth" would be established by validated reference measurement devices or controlled physiological conditions. The document does not describe the use of experts to establish ground truth in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable in the context of this submission. Adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers assess cases and their disagreements need to be resolved to establish a "ground truth" or reference standard. For a vital signs monitor, the performance is typically assessed against a known standard or reference measurement, not through human consensus.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily for diagnostic medical devices (e.g., AI for radiology) to compare the performance of human readers with and without AI assistance. This submission is for a vital sign monitoring system, and the equivalence is established through conformance to performance standards and comparison to predicate devices, not improvement in human reader performance.

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

The device is a patient monitoring system, which intrinsically involves a human-in-the-loop (healthcare professional) for operation and interpretation. The "performance" refers to its accuracy and reliability in measuring physiological parameters, which is assessed against objective standards, not as a standalone AI algorithm independent of human use. The performance data is essentially "standalone" in the sense that the device's measurements are validated against reference measurements, assuming correct operation by a human, but it's not an AI algorithm in the typical sense of generating a diagnosis or recommendation.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Validated Reference Measurement Devices: For parameters like SpO2, NIBP, temperature, CO2, and anesthetic agents, the "ground truth" is typically obtained from highly accurate, calibrated reference instruments under controlled conditions (e.g., volunteer blood study for SpO2, calibrated pressure sources for NIBP, known gas concentrations for CO2/agents).
• Consensus Standards: Conformance to recognized international and national standards (e.g., ISO 80601 series) dictates the methods for validation and the acceptable ranges of error, effectively serving as the definition of acceptable "ground truth" performance.

8. The Sample Size for the Training Set

The provided document does not mention "training sets" in the context of machine learning or AI algorithms. This device is a physiological monitor, not an AI/ML-based diagnostic or prognostic tool. Therefore, there is no "training set" in the sense of data used to train an algorithm. The development of such devices relies on engineering design, validation against physical and physiological models, and adherence to established measurement principles, not data-driven machine learning.

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

As there is no mention of an AI/ML training set, this question is not applicable.

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The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

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

• The arrhythmia detection, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
• C.O. monitoring is intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

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

• The arrhythmia detection and PAWP is intended for adult and pediatric patients only
  The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor
• BeneVision N19 Patient Monitor
• BeneVision N22 Patient Monitor
• BeneVision N1 Patient Monitor

The BeneVision N Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.

The provided document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

Therefore, many of the requested elements for a detailed study description (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and ground truth establishment for training data) are not present in the provided text.

The document primarily highlights changes from predicate devices and states that functional and system-level testing, along with compliance with consensus standards, demonstrate equivalence.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for a new device's efficacy study. Instead, it compares the specifications of the subject device with those of predicate devices, implicitly indicating that the subject device's performance meets or exceeds the predicate's established performance or relevant cleared standards.

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

The document does not specify sample sizes for test sets. The testing mentioned is referred to as "functional and system level testing" and "bench testing." It also states Mindray conducted "clinical testing to demonstrate that the Mindray and Nellcor SpO2 modules meet relevant consensus standards."
There is no mention of data provenance (e.g., country of origin of data, retrospective or prospective).

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

Not applicable. The document does not describe the use of experts to establish ground truth for testing. The evaluation focused on meeting specifications and consensus standards, and demonstrating equivalence to predicate devices.

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

Not applicable. There is no mention of adjudication methods.

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 is a patient monitor, not an AI-assisted diagnostic device, and no MRMC studies are mentioned.

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

The document describes performance in terms of functionality and adherence to technical specifications and consensus standards, not in terms of "algorithm-only" performance as would be relevant for an AI device. The tests performed are for the integrated device.

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

The term "ground truth" is not used. The performance evaluation is based on meeting engineering specifications, comparing against predicate device performance, and compliance with recognized consensus standards (e.g., IEC, ISO, AAMI standards for physiological measurement accuracy).

8. The sample size for the training set

Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a patient monitor, and no machine learning model training is discussed.

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

Not applicable, as no training set for a machine learning model is mentioned.

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The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.

MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.

The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of a HCP.

The MATRx plus is a new ventilatory effort recorder device. The MATRx plus recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation, snoring and body position during sleep. The physician prescribed device is worn on the patient's abdomen attached to a reusable effort belt and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives input from the sensors and wirelessly transmits the data to a bedside Tablet during the study.

The Tablet is set up through a connection to the web portal by the Health Care Professional (HCP) prior to deploying the device to the patient for use in the home. The Tablet runs the MATRx plus application according to the selected study type, records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording the Tablet advises the patient if sufficient data for analysis were recorded during the night.

After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis.

The Zephyr Sleep Technologies MATRx plus device, a ventilatory effort recorder for aiding in the diagnosis and assessment of sleep-disordered breathing in adult patients, underwent bench testing and performance comparisons to demonstrate substantial equivalence to its predicate device, the ApneaLink Air (K143272).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance metrics (like sensitivity, specificity for diagnosing sleep-disordered breathing). Instead, it focuses on demonstrating technological equivalence to the predicate device and satisfactory performance in bench testing.

Therefore, the table below reflects the comparison of technological characteristics between the MATRx plus and its predicate device, ApneaLink Air, as presented in the submission. The acceptance criterion is implicit: the MATRx plus should be "substantially equivalent" in its performance and features to the predicate device.

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

The document mentions validation of the "Autoscoring algorithm for ODI" (Oxygen Desaturation Index) by comparing its output with the Snore SAT monitor (K002159).

• Test Set Sample Size: 179 patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's mentioned as "data from 179 patients" when comparing the autoscoring algorithm. The study appears to be retrospective, using existing data for comparison.

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

The document states: "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."

• This implies that the "ground truth" for the ODI autoscoring comparison was the output of the Snore SAT monitor (K002159).
• The document does not specify the number of human experts, their qualifications, or their role in establishing this ground truth for the test set. It relies on the predicate device's (or reference device's) established output as the comparative standard.

4. Adjudication method for the test set

Not applicable. The ground truth for the ODI autoscoring was based on the output of a previously cleared device (Snore SAT monitor), not on human consensus or adjudication in this specific context.

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 is mentioned for the MATRx plus. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and bench testing, not on assessing human reader improvement with AI assistance.

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

Yes, a standalone performance assessment was done for the Autoscoring algorithm for ODI.

• "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."
• This suggests the MATRx plus's algorithm-driven ODI calculation was directly compared to the output of a reference device without human interpretation as part of this specific comparison.

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

For the ODI autoscoring algorithm validation, the ground truth was the output of a legally marketed predicate/reference device, the Snore SAT monitor (K002159). This is a form of "reference device data" ground truth, not pathology, expert consensus, or outcomes data in this specific study.

8. The sample size for the training set

The document does not provide information on the sample size used for training any algorithms within the MATRx plus device. The focus of this 510(k) summary is on demonstrating equivalence, not on detailing algorithm development and training.

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

Not provided in the document. As no information on the training set is included, the method for establishing its ground truth is also absent.

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The Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System is intended for:

• General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position.

• The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode.

• The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less.

• This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

• The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the Oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI.

The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHg as the high negative pressures can result in uncontrolled fluid flow.

The MRidium 3860+ MRI Infusion Pump/Monitoring System with software version 3.5.3 is an MRI compatible IV pump intended for use within the MR Scan room. The device operates to full specification in magnetic fields of up to 10,000 Gauss and has RF emissions at Larmor frequencies up to and including 3.0 Tesla MR scanners (132 MHz) such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is such that there is no hazard of magnetic attraction.

The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (nonmagnetic) motor. This integral channel is vertically oriented to the right side of the main assembly of the pump unit shall contain the controls, display, power supply, battery, processor/memory functions suitable to meet the complete and expanded system requirements.

The left side of the unit is designed to accommodate attachment of an optional second peristaltic pump channel (Model 3861) which is controlled through the main pump assembly's display and controls. A remote display (Model 3865) is also available for independent viewing and control from the adjacent MRI Control areas.

The Dose Rate Calculator feature, allows the user to set up a patient's infusion rate based upon user selected parameters, including volume to be infused, dose, concentration, weight, and/or time.

The Dose Rate Calculator feature also provides a Drug Library, allowing the user to program a patient's infusion protocol from selected parameters, including volume to be infused, dose, concentration, weight and/or time.

The Drug Library includes a small drug library consisting of 5 drugs (four common medications most frequently infused during MRI procedures, and one customizable drug) and with the DERS library card, can hold up to 50 customizable drugs. The optional DERS library card also includes the ability of setting hard and soft limits for each drug. This Drug Library feature can only be activated/de-activated with a service-related, limited user access menu.

The Dose Error Reduction System (DERS) option (P/N 1145) to the Dose Rate Calculator feature allowing user facilities to program custom drug names, doses, and limits for use in the Dose Rate Calculator. A user programmable drug library memory card stores the specific infusion protocols established by the hospital facility. This library is accessed using the pump's Dose Rate Calculator Menu. The drug library card supports a number of separate user-programmed infusion protocols for either primary and/or primary/bolus infusions, retrievable by drug/protocol name. The library can be programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum) and soft limits (high and low limits that require a user confirmation to exceed) for: Dose, Concentration, Time and Patient Weight can be programmed. Programming the custom medications and limits is performed with the pump and a dedicated drug library SD Memory Card in the limited access service mode.

The Pulse Oximeter feature of the 3860+ MRI Infusion Pump/Monitoring System is used in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. It is indicated for continuous monitoring of patients in the MRI who are well or poorly perfused. The 3860+ System displays the patient's pulse rate and SpO2 values, as well as applicable alarm limits. The 3860+ System includes adjustable and visual pulse rate and oxygen saturation (SpO2) alarms. It also includes a variety of additional features, including low battery alarms, status indicators and sensor-related alarms. The 3860+ System only uses fiberoptic SpO2 sensors. These fiber optic sensors, cables, and associated finger wrap accessories contain no conductive components; they can be applied safely to the patient while inside an MR (magnetic resonance) environment. The 3860 model number is used for the same infusion device with no SpO2 module.

This document describes the Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System, which is a medical device intended for infusing fluids to patients before, during, or after MRI scans, and for monitoring pulse oximetry. The submission is for a 510(k) premarket notification, claiming substantial equivalence to a predicate device (MRidium 3860 MRI Infusion Pump/Monitoring System, K090087).

Here's the information requested based on the provided text, focusing on the changes from the predicate device (software update and pulse oximeter):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of an AI/ML device. The testing described is verification and validation (V&V) for the infusion pump and pulse oximeter, and it focuses on the safety and performance of the device's functions, not on a diagnosis or prediction task from a specific dataset. Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) as typically understood for an AI/ML study is not applicable to this submission. The "test set" would typically refer to the data used to evaluate AI model performance, which isn't the primary focus here.

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

As this is not an AI/ML device study involving ground truth establishment by experts on medical imaging or similar data, this information is not applicable. The ground truth for device performance would be established by validated test methods and reference measurements or standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as there is no mention of a human-adjudicated test set in the context of an AI/ML device.

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. The submission is for a medical device (infusion pump/monitoring system) and does not involve AI assistance for human readers in diagnostic tasks.

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

This information is not applicable. This is not an AI algorithm being evaluated for standalone performance. The device itself (infusion pump and pulse oximeter) operates with software, and that software's performance is verified and validated as part of the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the specific performance testing detailed in this document:

• Software V&V: The ground truth is the design input and safety requirements for the software. This would be established through a rigorous software development lifecycle and adherence to recognized software engineering standards.
• Human Factors: The "ground truth" for human factors is compliance with the usability engineering guidance (FDA guidance). This would involve testing with representative users performing intended tasks.
• Risk Management: The "ground truth" for risk management is adherence to ISO 14971 and the FDA guidance for infusion pumps, ensuring identified risks are mitigated.
• Pulse Oximeter: The "ground truth" for the pulse oximeter's performance (SpO2 and pulse rate measurement accuracy) would be based on established physiological measurement standards and reference devices. The document states that performance specifications are "identical" to the predicate and that the OEM Masimo Set Technology (K053269) for pulse oximetry was previously cleared.

8. The Sample Size for the Training Set

This information is not applicable. The device is an infusion pump and monitoring system, not an AI/ML model that is "trained" on a dataset in the conventional sense. The software development process involves coding and internal testing, not machine learning training.

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

This information is not applicable for the same reasons as point 8.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI.

The proposed Monitor B40V3 is still a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2.1 (K133576) and now complies with IEC60601-1 3rd edition and RoHS (Restriction of Hazardous Substances) requirements, enabled time synchronization in HL7(Health Level 7) network environment, verified compatibility with CARESCAPE Central Station (K133882) and supported OAC (Optional Activation Codes) tool used in manufacturing and service for product license control. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to interface with following optional extension modules: E-MiniC module (K052582), Airway Gas Option Module (N-CAiO) (K133576), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and Entropy module. Comparing with E-Entropy module version (E-ENTROPY-00) (K061907) supported in predicate device, the proposed Monitor B40V3 supports improved E-Entropy module version (E-ENTROPY-01) (K150298). As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to be compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) with spirometry function disabled. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 still includes features and subsystems that are optional or configurable. The proposed Monitor B40V3 will continue interfacing to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes the GE Medical Systems China Co., Ltd. Monitor B40 (K151063), a multi-parameter patient monitor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of analytical or clinical performance.

Instead, the document focuses on:

• Substantial Equivalence: Demonstrating that the Monitor B40 (V3) is substantially equivalent to its predicate device (Monitor B40V2.1, K133576).
• Design Changes and Rationale: Explaining minor design modifications (e.g., compliance with IEC60601-1 3rd edition, RoHS compliance, time synchronization, compatibility updates, component upgrades due to end-of-life parts) and asserting that these changes do not impact the device's ability to obtain patient measurements or its safety/effectiveness.
• Compliance with Standards: Listing numerous voluntary and international standards the device and its applications comply with (e.g., IEC 60601-1, IEC 62304, ISO 80601-2-56).
• Quality Assurance Measures: Detailing the development process, including risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety).

Therefore, many of the requested points cannot be extracted from the provided text. The document explicitly states: "The subject of this premarket submission. The proposed Monitor B40V3 did not require clinical studies to support substantial equivalence." This indicates that detailed performance metrics from a dedicated clinical study for this specific device (B40V3) are not present in this submission.

Here is what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly listed as quantitative performance metrics for a specific function (e.g., arrhythmia detection sensitivity/specificity, NIBP accuracy). Instead, acceptance criteria implicitly refer to compliance with the listed international standards and demonstrating substantial equivalence to the predicate device, implying that its performance is at least as good as the predicate.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for any of the monitored parameters (ECG, SpO2, NIBP, etc.) for the Monitor B40V3 itself. The document claims "no changes to the parameter measuring principle" and that "all related risks were re-evaluated and found to be unchanged," implying performance is comparable to the predicate device.

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

• Not provided. The document does not describe specific test sets for analytical or clinical performance of the device's monitoring functions. It mentions "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," and "Safety testing" as part of quality assurance, but no details on size, provenance, or type of data are given.

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)

• Not applicable/Not provided. Since no specific clinical or analytical performance study with a 'test set' requiring expert ground truth is described, this information is absent. The submission focuses on technical compliance and substantial equivalence rather than de novo performance validation.

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

• Not applicable/Not provided. As no performance study with a test set requiring 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/Not provided. This device is a physiological monitor, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or described.

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

• Not explicitly described as a standalone performance study. The device itself functions in a "standalone" mode as a monitor, and its algorithms (e.g., ECG EKPRO V12, NIBP) operate without human intervention in their core function. However, no specific "standalone study" with performance metrics for these algorithms is described in this document for the B40V3. The document states that the Monitor B40 can be a stand-alone monitor or interfaced to other devices.

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

• Not applicable/Not provided. For a physiological monitor, ground truth would typically be established against highly accurate reference devices or established clinical standards. However, since no specific clinical performance study is detailed, the method for establishing ground truth for performance metrics is not mentioned. Compliance testing for standards (e.g., IEC, ISO) would rely on defined test methodologies and reference values.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a "training set" for AI or machine learning algorithms within this submission. The device uses established algorithms for physiological parameter monitoring.

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

• Not applicable/Not provided. As there is no mention of a training set.

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The Oximetry Module can be used with Philips Respironics BiPAP C Series (BiPAP AVAPS and BiPAP S/T) ventilators to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate for adult and pediatric patients. The Oximetry module may be used in a hospital or home care environment.

The Philips Respironics BiPAP C-Series Ventilatory System (BiPAP AVAPS and BiPAP S/T) is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of ages; > 18 kg) patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C-Series Ventilatory Support System may be used in the hospital or home.

The Respironics BiPAP C-Series (BiPAP AVAPS and BiPAP S/T) Ventilatory Support Devices when used with the Respironics Link Module Oximetry Interface Kit provides access to patient therapy information through the two-way transfer of data between patient devices and clinicians through the appropriate software including therapy efficacy and device settings as requested by the attending physician.

The Oximetry Interface Kit consists of the following components:

• Respironics Link Module
• SD Card and Mailer
• Masimo Oximetry Module and Sensor

When connected to the flow generator, the oximetry module records treatment and pulse oximetry data during therapy. The data is stored on a secure digital card. After treatment, the secure digital card containing the data can be removed from the device and sent to the clinician for review.

The Respironics BiPAP C-Series (BIPAP AVAPS and BiPAP S/T) devices, cleared under K092818, when used with the Respironics Oximetry Interface Kit are microprocessor controlled blower based positive pressure systems that interface with an with integrated heated humidifier, like the predicate cleared in K102465.

I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance tables, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document describes a 510(k) submission for a medical device (Respironics BiPAP Ventilator Series Oximetry Interface Kit) and focuses on administrative information, intended use, device description, non-clinical testing, and a statement of safety and effectiveness, mostly comparing it to predicate devices.

The "Test Execution Summary" section mentions several tests (Time Meters, Standard Regression Test, Pulse Oximetry User Interface, Pulse Oximetry Logging, Serial Port AutoBaud Detection, User Interface – Monitor Parameters Submenu) and states that "All tests have passed and requirements referenced in these tests have been verified," and "All tests were verified to meet the required acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. It also does not delve into the methodology of studies with details like sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or how ground truth was established for training sets, which are usually part of more comprehensive study reports rather than a 510(k) summary.

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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 alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.

The provided text is a 510(k) summary for the Philips Medical Systems Masimo SET SpO2 module. This document focuses on establishing substantial equivalence of a new device to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device's specific clinical efficacy or accuracy.

Therefore, much of the requested information cannot be directly extracted from the provided text. The summary explicitly states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry module functionality meets all reliability requirements and performance claims."

This indicates that the testing performed largely confirmed the new device's ability to operate similarly to the predicate under various conditions, rather than a clinical study establishing new performance benchmarks.

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 states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It does not provide specific acceptance criteria or reported device performance metrics in a table format for the new device. The focus is on equivalence, not on new performance claims.

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 provided in the 510(k) summary. The summary refers to "system level tests, integration tests, environmental tests, and safety testing," which are typically laboratory or engineering tests, not clinical studies with a "test set" in the context of patient 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)

This information is not provided. As noted above, the "test set" likely refers to engineering testing, not a clinical dataset requiring expert ground truth.

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 information is not provided. The device is an SpO2 module, which provides a physiological measurement, not an AI-powered diagnostic tool requiring human reader studies to improve interpretation. An MRMC study would not be relevant in this context.

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

The device is a pulse oximetry module, which inherently provides a standalone measurement (SpO2, pulse rate). The summary confirms its "functionality" and "performance claims," implying its ability to provide these measurements independently. However, the exact details of standalone performance metrics are not explicitly stated beyond meeting predicate specifications.

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

For a pulse oximeter, "ground truth" for accuracy is typically established through controlled desaturation studies compared against arterial blood gas measurements. The provided text does not detail the type of ground truth used for specific accuracy validation, but implies it was sufficient to demonstrate equivalence to the predicate.

8. The sample size for the training set

This information is not provided. Pulse oximeters do not typically employ a "training set" in the machine learning sense. Their algorithms are based on established physiological principles and signal processing, often calibrated and validated against clinical data, but not "trained" as an AI model would be.

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

As there is no "training set" in the AI sense for this device, how its ground truth was established is not applicable and therefore not provided.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a detailed clinical study report on the new device's performance metrics against specific acceptance criteria.

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