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The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The 3160 MRI Patient Monitoring System is intended for use by health care professionals.

The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 orovides accurate, continuous, and reliable performance during all phase of MRI applications.

Here's a summary of the acceptance criteria and study information for the K050399 device, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Vision Telepak™ Telemetry Transmitter is portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.

The Vision Telepak Telemetry Transmitter unit is a portable, wireless, patient monitor intended to be used for monitoring the ECG and SpO2 vital signs of critically ill and pediatric patients. The Telepak unit is used in all areas of the hospital which utilize telemetry transmitters for ECG and/or SpO2 monitoring. The Telepak transmits vital sign information to an ESCORT Vision Central Station or an ESCORT Series bedside monitor. Both the central station and beside monitors were cleared under K970763.

Here's an analysis of the provided text regarding the Vision Telepak™ Telemetry Transmitter, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided general information, the acceptance criteria and specific performance metrics are not explicitly detailed in a quantitative table. However, we can infer the general acceptance criteria and the claimed performance:

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

The provided documentation does not explicitly state the sample size used for the performance testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "The study conducted to compare equivalency..."

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

This information is not provided in the submitted documents. The device is for physiological monitoring (ECG and SpO2), which typically relies on established medical standards and potentially reference instruments, rather than expert interpretation of images or complex data needing multiple clinical experts.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device (physiological monitoring), traditional adjudication methods (like 2+1 or 3+1 for imaging) are unlikely to apply. Performance would likely be assessed against reference instruments or established clinical guidelines.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is typically relevant for interpretative devices (like AI for image analysis) where human readers' performance is being evaluated with and without AI assistance. The Vision Telepak™ is a monitoring device, not an interpretative AI system in the context of this submission.

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

A standalone performance study of the device itself was implicitly done as part of the "Performance Testing." The statement "met the performance requirements for accuracy and precision relative to the reference laboratory system" suggests an evaluation of the device's output against a known standard, independent of user interpretation for its core measurements (ECG and SpO2). However, this is not an "algorithm only" study in the sense it would be for an AI diagnostic tool, but rather the performance of the physical monitoring device.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was a "reference laboratory system." This implies that the device's ECG and SpO2 measurements were compared against highly accurate and precise reference instruments or methodologies in a controlled laboratory setting.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Vision Telepak™ Telemetry Transmitter, as described in this 510(k) summary, is a traditional medical device for vital sign monitoring, not a machine learning or AI-based device that would typically have a "training set." Its functionality is based on established engineering and physiological principles.

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

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

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The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.

The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is a significant modification of the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System. This device has been integrated into the Philips Physiotrak patient gurney used with the Philips MRI System. The Philips Medical Systems Integrated Patient Monitoring System is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner. The IPMS works on DC (battery) power supplies and monitors ECG, non-invasive blood pressure, SPO2, respiration and temperature. This information can be displayed either at the monitor or remotely. The monitor sounds an alarm if any monitored parameter falls outside the range indicated by the alarm limits. The alarm limits is programmable either manually or programmally based on the current value of the parameter(s). This monitoring system is MRI-compatible. It utilizes technology from the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System and the Invivo Research Millennia Patient Monitor. The IPMS consists of three major component parts; the MCB (Patient Connector Box), MEB (Monitoring Electronics Box), and MDCU (Monitoring Display and Control Unit) which are integrated into the Phillips Physiotrak patient gurney.

The provided text describes the acceptance criteria and a summary of performance testing for the Philips Medical Systems Integrated Patient Monitoring System (IPMS). However, it does not include a detailed study description with information like sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing full clinical study details.

Here's the information that can be extracted from the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

The 3150M Fiber-Optic Temperature option enables the measurement of a patient's surface temperature both safely and accurately during all MRI procedures. This option utilizes a fiber-optic cable for interface between the temperature sensor at the patient application site and the measuring device. With this scheme, light channeled through a fiber-optic cable is the medium of temperature measurement rather than electrical conductor based components. The fiber-optic cable is impervious to the RF energy present during MRI procedures, thus eliminating the possibility of heating.

The Fiber-Optic Temperature option contains four items: 1) Re-usable fiber optic surface temperature sensor. 2) Disposable surface temperature sensor applicator for use on patients ranging from Neonatal (5 kilograms) to Adult. 3) Fiber optic connector on the outside of the 3150M. 4) Signal conditioner inside 3150M patient monitor.

The provided text describes the Invivo Research Inc. Magnitude™ 3150M MRI Monitor, which monitors various parameters, including temperature. The focus of the performance testing summary in the document is on the specifications for the temperature option of the device.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes a table of specifications that serve as acceptance criteria for the temperature monitoring function of the device. The reported device performance is stated as conforming to these specifications.

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The Invivo Research Inc. The Centurion™ Central Station Arrhythmia Patient Monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor patients' cardiac arrhythmias during ECG monitoring. The need to monitor these arrhythmias is most commonly encountered in the intensive care areas of the hospital during patient monitoring. 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 Centurion™ Central Station with Arrhythmia Monitoring System is a Central Station monitor comprised of a standard VGA display, a standard Personal Computer (PC) base system, and hardware used to install the Network communications system (i.e. spreadspectrum transponders and UHF telemetry receivers). The Centurion™ Central Station with Arrhythmia Monitoring System can provide the centralized display, storage and recording (or printing) of patient vital sign and waveform data that is being monitored at the Invivo Research Inc. Millennia 3500 Series bedside monitors or spread-spectrum/UHF telemetry receivers. Data accumulated at the Millennia 3500 Series bedside monitors is sent via a proprietary spread-spectrum LAN (local area network) to the Central Station for display, storage, and/or printing. Data accumulated from any of the Invivo Research Inc. telemetry transceivers is sent directly to the Central Station on standard UHF telemetry frequencies. The Central Station oversees all communications activities, allowing each system component to pass information along without interruption of patient monitoring. The Central Station with Arrhythmia monitoring provides alarm detection and reporting for all patient parameters that are available to the Central Station, including arrhythmia monitoring for up to 8 patients. The Central Station alarm capability supplements the existing bedside monitor alarm capability (alarms at both locations). The Central Station can provide storage of patient data for 8 patients for up to 24 hours. This includes waveform and patient parameter data for all available parameter values. The waveform and parameter data that has been stored in a patient file at the Central Station can be retrieved and reviewed on the display or printed out on a thermal array recorder or laser printer.

The provided text describes a 510(k) submission for the Centurion™ Central Station with Arrhythmia Patient Monitoring System. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving device performance.

Here's what can be extracted and what is missing:

Missing Information:

• Specific Acceptance Criteria: The document states "The Invivo Research Inc. Centurion™ Central Station with Arrhythmia Monitoring System conforms with national and available international product safety standards for electrical. electromagnetic compatibility, and cardiac monitoring." and "Tests demonstrating consideration and mitigation of the identified potential hazards for this device have been developed, and will be complete before release of the device." This implies that there are acceptance criteria for safety and performance, but the actual criteria (e.g., sensitivity, specificity for arrhythmia detection, alarm accuracy thresholds) and reported device performance metrics are not provided.
• Study Details: There is no detailed description of a specific study that tested the arrhythmia detection performance of the device against predefined acceptance criteria.
• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.
• Number of Experts/Qualifications for Ground Truth: Not specified.
• Adjudication Method: Not specified.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, and generally not applicable for a standalone arrhythmia detection system like this.
• Standalone Performance: While the device functions as a standalone system, the specific performance metrics (like sensitivity, specificity, accuracy for arrhythmia detection) are not reported. The document only generally states it "provides alarm detection and reporting for all patient parameters... including arrhythmia monitoring for up to 8 patients."
• Type of Ground Truth: Not specified. For an arrhythmia detection system, this would typically involve expert-reviewed ECG recordings.
• Sample Size for Training Set: Not specified.
• How Ground Truth for Training Set Was Established: Not specified.

Information that can be extracted:

Here's a table based on the limited information available, with significant sections marked as "Not Provided in Document":

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance
Not provided in the document.

3. Number of Experts and Qualifications for Ground Truth
Not provided in the document.

4. Adjudication Method
Not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned in the document. This type of study is typically for image-based AI systems where human readers are interpreting data. This device is a monitoring system that directly detects arrhythmias.

6. Standalone (Algorithm only) Performance
The device itself is a standalone system for arrhythmia detection. However, specific performance metrics (e.g., sensitivity, specificity, positive predictive value, negative predictive value for different arrhythmia types) are not reported in this summary. The document only confirms its capability to perform these functions.

7. Type of Ground Truth Used
Not provided in the document. For an arrhythmia detector, ground truth would typically be established by expert cardiologists reviewing ECG recordings.

8. Sample Size for Training Set
Not provided in the document.

9. How Ground Truth for Training Set Was Established
Not provided in the document.

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The Invivo Research Inc. Millennia 3500 Series Monitor with Anesthetic Agent monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents whonitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide and Additionally, this more and to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. This device is available for sale only upon the order of a physician or other related licensed medical professional.

The Millennia 3500 Series Monitor with Anesthetic Agents Monitor is a patient monitor which draws a continuous flow of sample gas from the patient's anesthesia breathing circuit. The sample is then drawn through a measurement sample cell where the agent(s) and other patient gas concentrations are measured. Measured values are displayed as numbers and waveforms on the main display of the monitor. The monitor is operated by controls on the front panel of the monitor. The major functional subsystems of the device are the power supply, the pneumatic system, the measurement sample cell, the system electronics and product software. Power is supplied by an AC power cord, or an internal set of batteries. AC power is internally conditioned by the power supply subassembly, which powers the system and charges the internal batteries. The pneumatic system draws sample gas into the device through a moisture collection system. The sample then enters the sample cell, which is a cavity within the optical bench assembly. The sample is then exhausted out the rear of the unit. The sample cell cavity allows infrared light to be passed through the sample so a detector on the other side of the sample can measure the amount of infrared light absorption. The infrared light source consists of a resistive element which radiates a relatively wide spectrum of infrared light. The amount of transmitted infrared light is measured by an optical detector, and several optical filters are used to determine the identity and concentration of the anesthetic agents, nitrous oxide and carbon dioxide. The oxygen measurements are obtained using a polarographic oxygen cell which also receives sample gas from the sample cell. The electronic system consists of an analog circuit board, and a digital circuit board. These boards are added to the existing standard Millennia 3500 Series Patient Monitoring System. The analog board takes the electrical signals from the sample cell assembly and conditions them so that measurement calculations can be performed. The digital circuit board digitizes the conditioned analog signals and performs measurement calculations. Proprietary software algorithms are used to calculate measured concentrations of anesthetic agents and patient gases in the sample gas.

The provided text describes the Millennia 3500 Series Monitor with Anesthetic Agent Monitoring. However, it does not contain specific acceptance criteria or detailed study results that would allow for a comprehensive table of acceptance criteria and reported device performance, nor does it provide the detailed information requested regarding sample sizes, expert qualifications, or comparative effectiveness studies.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing full study protocols and results. It states that "The Invivo Research Inc. Millennia 3500 Series Monitor with Anesthetic Agent monitor conforms with national and available international product safety standards for electrical, electromagnetic compatibility, and anesthetic agent monitoring." This is a general statement about compliance but not a detailed presentation of performance data against specific criteria.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an attempt to answer based on the available information and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The actual numerical acceptance criteria for accuracy, drift, response time, etc., are not provided in this document. The stated "same performance specifications as predicate devices" is the primary performance claim.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. Performance testing is mentioned generally, but no details on the number of cases or samples are provided.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or if the data was retrospective or prospective.

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

• Not specified. The document does not describe the establishment of a "ground truth" using human experts for performance testing. Performance is likely assessed against calibrated gas mixtures or reference devices, not human expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. This typically applies to studies involving human interpretation or clinical outcomes, which are not detailed here.

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

• No. An MRMC study was not done, as this device measures gas concentrations and does not involve human readers interpreting images or data in the same way an AI diagnostic tool would.

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

• Yes, implicitly. The device is a monitor that provides numerical readouts of gas concentrations. Its performance is inherent to the algorithm and sensors (standalone) without a human-in-the-loop directly influencing the measurement calculation itself. The "Proprietary software algorithms are used to calculate measured concentrations."

7. The Type of Ground Truth Used

• Inferred: Calibrated gas standards or reference measurement devices. For a gas analyzer, the ground truth for "concentration" would be established by preparing gas mixtures with known, precise concentrations and then measuring how accurately the device reports these known values. This is not explicitly stated but is the standard method for such devices.

8. The Sample Size for the Training Set

• Not applicable/Not specified. The document does not describe the development or training of AI/ML models in the modern sense that would require a "training set" of data labels. The device uses "Proprietary software algorithms" for calculations, but these are likely deterministic algorithms based on physical principles (infrared absorption) rather than statistical or neural network models trained on large datasets.

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

• Not applicable/Not specified. As above, the concept of a training set ground truth, as used for AI/ML, does not appear relevant to the described device.

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This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use.

This device includes the capability for monitoring the following patient parameters:

• ECG .
  Heart Rate .

Pulse Oximetry .

Non-Invasive Blood Pressure ●

. Invasive Blood Pressure

End-Tidal Carbon Dioxide / Nitrous Oxide .

Respiration effort .

. Rra

Not Found

This document is a 510(k) clearance letter from the FDA for a patient monitor and does not contain the detailed study information typically requested for AI/ML device evaluations, such as acceptance criteria, performance metrics, sample sizes, or ground truth establishment.

A 510(k) clearance evaluates a new device for substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety like a PMA (Premarket Approval). Therefore, the document focuses on regulatory approval rather than a detailed performance study report.

Based on the provided text, I cannot extract the following information:

• A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device itself.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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/ML device, so such a study would not apply.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI/ML device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

The document primarily states:

• Device: Omni-Trak™ 3150 Series Patient Monitor
• Intended Use: Patient vital signs monitor during magnetic resonance imaging (MRI) scans. To be used by or on the order of a physician or similarly qualified healthcare professional in hospital environments (MRI, Radiology Clinic, or similar settings). Not intended for home use.
• Monitored Parameters: ECG, Heart Rate, Pulse Oximetry, Non-Invasive Blood Pressure, Invasive Blood Pressure, End-Tidal Carbon Dioxide / Nitrous Oxide, Respiration effort.
• Regulatory Class: II (two)
• Product Code: 74 MHX
• Determination: Substantially equivalent to devices marketed prior to May 28, 1976.

To obtain the kind of study data requested, one would typically need access to the full 510(k) submission, which would include detailed testing protocols and results demonstrating the device meets its own specifications and is substantially equivalent to a predicate device in terms of safety and effectiveness, but not necessarily advanced AI/ML performance metrics as posed in the question.

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