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The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

• The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.
• In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

The Envoy is a multiparameter physiological patient monitor, capable of monitoring:

• ECG/Heart Rate .
• Invasive blood pressure .
• Non-invasive blood pressure ●
• Respiration ●
• Pulse oximetry
• Two temperature channels ●
• Cardiac output ●
• EtCo2 .
• Spirometry ●
• EEG ●
• BIS module (new subject of this application) .

The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.

The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.

The BIS Module is used to monitor dual channel EEG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness.

The BIS index together with several quality parameters are displayed and stored by the Envoy monitor.

The Mennen Medical Envoy BIS module is a modification to the existing Envoy Patient Monitor, adding Bispectral Index (BIS) monitoring capabilities. The device claims substantial equivalence to the predicate device, the Spacelab Medical Bispectral Index (BISx) Analysis Module 91482 (K060900).

The provided text outlines the functional description of the new BIS module and its comparison to the predicate device, focusing on display formats, data storage, and alarm functionalities. It also references "performance testing" and "SW Validation" but lacks specific details regarding acceptance criteria and the results of these studies.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence by comparing the functional and technical specifications of the Envoy BIS module with the predicate device. The primary claim for acceptance is that the Envoy BIS module's function to display BIS parameters and quality parameters, and its alarm capabilities, are equivalent to the predicate device.

The document highlights the following parameters and their ranges as displayed and stored by the Envoy monitor, which are derived from the BISx unit:

The "Similarities" and "Differences" sections (Page 9) act as an indirect comparison of performance criteria, stating that differences in display options between the two devices "do not change the efficiency of BIS and EEG displays of both monitors," implying an equivalence in performance.

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

The document does not provide details on the sample size used for any specific test set related to the BIS module. There is no mention of human subject data, country of origin, or whether it was retrospective or prospective. The testing described primarily appears to be technical validation against the predicate device's performance.

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

No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set. The validation primarily focuses on comparing technical specifications and functional equivalence.

4. Adjudication Method for the Test Set

No information on an adjudication method for a test set is provided.

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

No MRMC comparative effectiveness study is mentioned, nor is any effect size for human reader improvement with or without AI assistance. The device is a patient monitor, not an AI diagnostic tool involving human reader interpretation. The BIS module aids in monitoring the effects of anesthetic agents to help guide administration and potentially reduce awareness with recall, but this is a clinical utility, not a reader study.

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

The BIS module itself processes EEG signals to generate the BIS index and related parameters. This processing can be considered "standalone" in the sense that the algorithm generates these outputs without direct human intervention in the calculation process. The device functions to "display the BIS parameter and the quality parameters" and to "provide alarm limits for the BIS index and provide visual and audible alarms." These outputs are generated by the device's algorithms based on the input from the BISx unit. However, the context of the question often implies a comparison to a clinical ground truth, which is not detailed here.

7. The Type of Ground Truth Used

The "ground truth" implicitly used in this submission is the established performance and output of the predicate device, the Spacelab Bispectral Index (BISx) Analysis Module 91482. The entire submission is built on demonstrating substantial equivalence to this legally marketed device. The "Substantial Equivalence Discussion" (Page 5) directly compares the Envoy BIS module's specifications and functionality to the predicate.

8. The Sample Size for the Training Set

No information is provided regarding a training set sample size. The device is not described as utilizing machine learning or AI that would typically involve a training set for model development. Its function appears to be based on established algorithms for processing EEG signals and deriving the BIS index, which are derived from the OEM (Aspect BISx).

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

As no training set is mentioned for the Envoy BIS module itself, there is no information on how its ground truth was established. The core processing capabilities for the BIS index are derived from the Aspect BISx unit (OEM agreement), suggesting that any fundamental ground truth for the BIS algorithm would have been established during the development and clearance of the original BISx device (K040183 and subsequently K060900 for the predicate).

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The Envoy is intended for use as a multiparameter monitoring system. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, EtCO2 and EEG. The EEG module is not intended for use on infants. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical Envoy is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. Intended clinical applications: Critical Care Patients, Cardiac Step-down/Telemetry Units, Emergency Departments, Intra-operative (Anesthesia) Monitoring, Post Anesthesia Care.

The Envoy is intended for use as a multiparameter physiological patient monitoring system for the monitoring and recording of patient information or any in-hospital application that requires patient monitoring. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, eTCO2 and EEG. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. This effectively allows the Envoy to monitor a wide-range of adult, pediatric, and neonatal patient conditions, in many different areas of the hospital. The Envoy consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules monitor the patient's vital signs. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient; the modules display the patient waveforms, vital signs information, and alarms indications on the Envoy display unit. The Envoy is not a life supporting, nor life-sustaining device; nor is it implantable; therefore sterility is not a consideration. The Envoy is not a kit and does not contain any drug or biological products.

The Envoy EEG module can monitor up to 4 differential EEG channels and display processed trend and real-time EEG waveforms. EEG monitoring is continuous and in real time. The Envoy EEG module does not have derived parameters such as Aspect BIS or other derived parameters. The Envoy EEG module can be used as an indicator of brain damage or cerebral activity. The EEG module is commonly used to monitor the cerebral activity of patients who have suffered serious head injury or to evaluate the state of consciousness of a patient. The EEG module of the Envoy patient monitor is not sold as a stand-alone EEG device, but as part of a multiparameter physiological patient monitoring system (Envoy). The primary purpose of the EEG module is to determine the need for more detailed EEG recordings. The EEG module is not a replacement for a comprehensive multi-channel (16 to 36 or more) EEG diagnosis by a neurology specialist. Since four channels are displayed simultaneously, qualitative assessments can be made regarding right and left hemispheric activity. The EEG module of the Envoy monitor consists of the following main parts/components: 5 lead input cable, Four channel differential amplifier, Processing and Storage circuit block (P&SB). The P&SB of the EEG module is identical to the Mennen Medical P&S Boards located in the other Envoy input modules. The P&SB consists of a communications processor and memory, and performs local data storage and protocol translation from low-level protocol to high level protocol. The Envoy can display between one and four EEG channels on and the user can control the sensitivity and the frequency response of the EEG waveforms. Both sensitivity and filters are common to all four channels. The top displayed EBG channel is stored in Overview for up to 72 hours.

The Envoy Patient Monitor with the new EEG module was determined to be substantially equivalent to the predicate device (EEG module of the Mennen Medical Horizon 2000 patient monitor (K910945)) through performance testing and comparison of technological characteristics.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Monitored Parameters and Features" table and the "Displayed Parameters" table, alongside the claim of compliance with relevant IEC standards. The "Reported Device Performance" is directly listed within these tables.

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The Envoy is intended for use as a multiparameter monitoring system.

The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, etCO2 and Spirometry. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.

The Envoy also includes a spirometer intended for continuous monitoring of adult and pediatric patients with tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages.

The Spirometry module is used to provide an objective measurement of lung function. The Spirometry module is intended for use in the hospital clinical environment only (e.g. in the RICU). The module is used for the continuous monitoring of mechanically ventilated adult and pediatric patients, or adult and pediatric patients able to breathe spontaneously. In both cases, the patient is connected to the module via an endotracheal tube or mask. The module is to be used only for patients with tidal volumes greater than 100 ml.

The Envoy is a multiparameter physiological patient monitor consisting of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules to monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. Data presented from the modules by the Envoy are presented on the monitor as waveform and numeric displays.

The Envoy vital signs modules acquire vital signs data from the patient, and display their indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.

The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such, it is not a life supporting, nor is it implantable and therefore sterility is not a consideration.

The Envoy is not a kit and does not contain any drug or biological products. The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY).

The provided document is a 510(k) premarket notification for a new Spirometry module added to the Envoy Patient Monitor. The document indicates that the device has been subject to "extensive safety and performance testing" but does not contain the detailed study results needed to fully answer your request.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides some specifications for the OEM Airway Adapter/Flow sensor which can be considered performance criteria and reported performance:

Missing Information for Table: The document states that the system included "various performance tests designed to ENSURE that the device complies to applicable requirements and performance specifications" but does not explicitly list the acceptance criteria or the full detailed results for all monitored parameters (Vt_e, PIP, PEEP, MAP, Plat, PF_i, PF_e, RR, Ve, I:E, COMP, RES, RSBI).

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

• Sample Size for Test Set: Not specified. The document mentions "extensive safety and performance testing" but does not provide details on the number of samples or cases used.
• Data Provenance: Not specified. It is not clear whether the testing involved retrospective or prospective data, or the geographical origin of any patient data, if used.

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

• Not specified. The document does not describe a process for establishing ground truth using experts. The testing seems to be based on engineering performance specifications rather than clinical reads.

4. Adjudication method for the test set

• Not applicable/Not specified. Since expert ground truth establishment is not described, adjudication methods are also not mentioned.

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. This is not an AI/CAD device. It is a physiological patient monitor with a spirometry module. An MRMC study is not relevant to this type of device.

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

• Yes, implicitly. The performance testing described refers to the device itself and its components. The document explicitly states, "The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY)." However, the performance specifications are for the module's technical capabilities (e.g., flow range, accuracy), which would be tested in a standalone capacity within the system.

7. The type of ground truth used

• Engineering Specifications/Reference Standards. The reported accuracy and flow range suggest comparison against known, calibrated inputs or reference standards rather than clinical consensus or pathology. Examples: "Accuracy: ± 5 % reading, or 0.5 lpm."

8. The sample size for the training set

• Not applicable/Not specified. This device is a hardware-based physiological monitor, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable. No training set is mentioned or implied for this type of device.

Study Proving Device Meets Acceptance Criteria:

The document states: "The Envoy Spirometry module has been subject to extensive safety and performance testing. The survey of the system included various performance tests designed to ensure that the device complies to applicable requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards."

This is a general statement that indicates testing was done, but the document does not detail the specific study, methodology, or results of this "extensive safety and performance testing" beyond the specifications provided in the table above. It does not provide a formal "study" report within this 510(k) summary.

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The Envoy is intended for use as a multiparameter physiological patient monitoring system. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical Envoy is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: Critical Care Patients, Cardiac Step-down/Telemetry Units, Emergency Departments, Intra-operative (Anesthesia) Monitoring, Post Anesthesia Care.

The Envoy is intended for use as a multiparameter monitoring system. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical Envoy is intended for sale as a system for remote monitoring and recording patient information or any in-hospital application requiring remote patient monitoring. The following are examples of intended clinical applications: Critical Care Patients, Cardiac Step-down/Telemetry Units, Emergency Departments, Intra-operative (Anesthesia) Monitoring, Post Anesthesia Care.

The Envoy is a multiparameter physiological patient monitor, capable of monitoring: ECG/Heart Rate, invasive blood pressure, non-invasive blood pressure, respiration, pulse oximetry, two temperature channels, cardiac output, eTCO2. The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time. The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting. nor life sustaining device; nor is it implantable and therefore sterility is not a consideration. The Envoy is not a kit, does not contain any drug or biological products and is not for prescription use. The sale of and use of the Envoy is restricted to qualified medical personnel only.

The 12L ECG telemetry module can be used instead of the regular ECG module to monitor the ECG of patients whose condition enables them to be mobile. ECG is monitored by attaching electrodes to the patient's chest and by connecting the electrodes via a cable to the ECG module in the patient monitor. A 10-wire cable enables ECG monitoring via 12 ECG leads, while a 5-wire cable enables the display of 7 ECG leads. The ECG signal is used to detect the QRS complex, and for the detection and alarm of Heart Rate, Arrhythmia and ST changes. The ECG telemetry does away with the need to connect the patient cable to the bedside monitor: instead, the patient cable is connected to a lightweight transmitter (240 gram) carried by the patient. This enables the patient to move around freely while being monitored by the Envoy patient monitor. The telemetry operating range is 15 meters (with no barrier) from the receiver. For a longer operating distance, you need to add an optional Antenna network. The Telemetry system can use up to 256 channels working in parallel. Each telemetry transmitter is coupled to one telemetry receiver. The telemetry receiver is located in a ECG Telemetry module connected to the Envoy module rack. The single width ECG Telemetry module is intended to be used to monitor 12 lead ECG for patients monitored by the bedside Envoy monitor. Telemetry monitoring is used when the condition of the patient enables him/her to move around.

Here's an analysis of the provided text regarding the Envoy Patient Monitor and its new 12L ECG/Telemetry module, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device. While it mentions "extensive safety and performance testing," it does not provide detailed quantitative acceptance criteria or specific study results showing the device meets those criteria, especially in a clinical performance context. The document primarily lists performance specifications and states that testing was performed to ensure compliance. Therefore, many sections of your request, particularly those related to clinical study design, will be answered with "Not explicitly stated" or "Not applicable" based on the limited information provided in this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications, which can be interpreted as the acceptance criteria that the device was designed to meet. The "reported device performance" is implied to meet these specifications as per the testing mentioned.

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

• Sample size used for the test set: Not explicitly stated in the provided document. The document mentions "various performance tests" and "Final testing for the system," but no specific patient or data sample sizes are given.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The manufacturer is based in Israel, so some testing may have occurred there, but this is not confirmed for a "test set." The nature of the testing described (performance, safety, EMC) suggests laboratory-based rather than clinical, patient-derived data directly.

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

Not applicable. The document describes engineering and safety testing against defined specifications and voluntary standards, not a clinical study involving expert interpretation of medical images or signals to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. As this was not a clinical study requiring expert consensus or adjudication on medical findings, no such method is described.

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

Not applicable. This document does not describe a clinical study comparing human reader performance with or without AI assistance. The device is a physiological monitor, not an AI diagnostic tool that requires human interpretation.

6. Standalone (Algorithm Only) Performance Study

Not explicitly described as a separate study with specific metrics. The "performance tests" mentioned are for the device as a whole, including its algorithms for ECG/HR and arrhythmia detection, but a dedicated "standalone" study demonstrating algorithm performance in isolation from the hardware and complete system is not detailed. The listed specifications for HR accuracy and QRS detection range imply algorithmic performance metrics.

7. Type of Ground Truth Used

The "ground truth" for the performance specifications would be established by:

• Engineering measurements against known electrical signals (for parameters like frequency response, input impedance, QRS detection range, HR accuracy).
• Compliance testing against the requirements of cited industry standards (IEC, AAMI/ANSI).
• Controlled scenarios for safety (e.g., defibrillation pulse protection) and EMC (electromagnetic compatibility) testing.

These are not "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense, but rather defined engineering and regulatory test conditions.

8. Sample Size for the Training Set

Not applicable. This device is a physiological monitor, not a machine learning or AI algorithm that relies on a "training set" of data in the way, for example, an image analysis AI would. Its functionality is based on established signal processing principles and hardware design.

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

Not applicable, as there is no "training set" for this type of device.

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ENVOY is intended for use as a multiparameter physiological patient monitoring system.

The ENVOY can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the ENVOY to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.

Functions include display of multiparameter waveforms, vital signs, alarm & status messages.

The Mennen Medical ENVOY is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.

The following are examples of intended clinical applications:

• · Critical Care Patients
• · Cardiac Step-down/Telemetry Units
• Emergency Departments
• · Intra-operative (Anesthesia) Monitoring
• · Post Anesthesia Care

The Envoy is a multiparameter physiological patient monitor, capable of monitoring:

• · ECG/Heart Rate
• · invasive blood pressure
• · non-invasive blood pressure
• · respiration
• · pulse oximetry
• · two temperature channels
• · cardiac output
• · eTCO2

The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays.

ENVOY vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the ENVOY display unit. Vital signs and waveform information are displayed simultaneously on the ENVOY Display Unit. Up to 8 traces can be displayed at any one time.

The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure and EtCO2 Modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.

Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message.

Operation of the ENVOY is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display.

ENVOY is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.

ENVOY complies with IEC 601-1 Medical Electrical Equipment, IEC 601-2-2-27 Safety of Electrocardiographic monitoring, IEC 601-2-30 Requirements for Automatic Cycling Indirect Blood Pressure monitoring, AAMI/ANSI SP-10/A1 Electronic or Automated Sphygmomanometers, IEC 601-2-34 Requirements for Invasive Blood Pressure monitoring, AAMI/ANSI ES1 Safe Current Limits for Electromedical Apparatus, and AAMVANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms. ENVOY is not a kit, does not contain any drug or biological products and is not for prescription use.

The ECG/Resp. module is the source of all ECG data in the Envoy bedside monitor. ECG is measured using a multi-lead cable via electrodes attached to the patient's chest.

Monitoring the ECG produces a continuous waveform of cardiac electrical activity to enable an accurate assessment of a patient's current physiological condition. With the ECG module, you can use a 3, 5 6 or 10 lead electrode ECG cable set to display up to 12 selectable ECG leads in up to three channels.

The 12 Lead ECG/Resp. module is housed in the Envoy module rack, where it occupies a single slot. It includes ECG and respiration monitoring.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "ECG/HEART RATE": {
      "Monitored Leads": {
        "Acceptance Criteria": "Same as predicate (3/5/6-leads)",
        "Device Performance": "3/5/6/12 leads"
      },
      "Sampling Rate and Resolution": {
        "Acceptance Criteria": "641 Hz sampling rate, 22 bit resolution",
        "Device Performance": "The same"
      },
      "Frequency Response - analog output": {
        "Acceptance Criteria": "Diagnostic: 0.05 to 150 Hz; Monitor: 0.5 to 40 Hz; Exercise: 1.0 to 25 Hz (According to ANSI/AAMI EC11 para.3.2.7.2)",
        "Device Performance": "The same"
      },
      "Input Impedance": {
        "Acceptance Criteria": "20M ohm typical; 5M ohm differential, dc to 10Hz; 2.5M ohm differential 10 to 100 Hz (as per ANSI/AAMI EC13 para.3.2.9.2)",
        "Device Performance": "The same"
      },
      "Common Mode Rejection (CMR)": {
        "Acceptance Criteria": "120 dB, minimum; Lead Fault Detection based on impedance",
        "Device Performance": "The same"
      },
      "Baseline Recovery": {
        "Acceptance Criteria": "within 3 sec, 1 sec after lead switch",
        "Device Performance": "The same"
      },
      "Gain Levels": {
        "Acceptance Criteria": "250 - 8000",
        "Device Performance": "The same"
      },
      "Pacemaker Detection and Rejection": {
        "Acceptance Criteria": "Amplitude: 2 mV to 700 mV; Width: 0.1 ms to 2.0 ms (as per ANSI/AAMI EC13 para.3.1.4); Pacemaker flag inserted into displayed waveform",
        "Device Performance": "The same"
      },
      "Patient Isolation": {
        "Acceptance Criteria": "Meets ANSI/AAMI ESI-1985 standard for Safe Current Limits for Electromedical Apparatus (5kV dc, 2.5kV AC)",
        "Device Performance": "The same"
      },
      "Heart Rate (HR) Counting": {
        "Acceptance Criteria": "20 to 300 BPM",
        "Device Performance": "The same"
      },
      "HR Accuracy": {
        "Acceptance Criteria": "± 2 BPM. Values below 20 are recorded as zero",
        "Device Performance": "The same"
      },
      "QRS Detection Range": {
        "Acceptance Criteria": "0.25 to 5.0 millivolt height; 70 to 120 milliseconds width",
        "Device Performance": "The same"
      },
      "Leads analyzed for: Hear Rate and Arrhythmia Configuration": {
        "Acceptance Criteria": "Top two displayed",
        "Device Performance": "The same"
      },
      "HR Alarm Settings": {
        "Acceptance Criteria": "20 (low) to 250 (high), non-overlapping",
        "Device Performance": "The same"
      },
      "Lead Fault Sense": {
        "Acceptance Criteria": "when ECG electrode is interrupted or becomes marginal",
        "Device Performance": "The same"
      },
      "Defib. Pulse Protection": {
        "Acceptance Criteria": "5KV (as per ANSI/AAMI EC13, clause 3.2.2.2 and per IEC 601-2-27, clause 17,101 and 102)",
        "Device Performance": "The same"
      },
      "Degree of protection against electrical shock": {
        "Acceptance Criteria": "Type CF",
        "Device Performance": "The same"
      },
      "Electrosurgical Interference Suppression Provided": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "The same"
      },
      "Dynamic Range": {
        "Acceptance Criteria": "differential voltage of up to ± 5mv at a rate up to ±320 mV/sec (as per ANSI/AAMI EC13, para. 3.2.9.1)",
        "Device Performance": "The same"
      },
      "Noise": {
        "Acceptance Criteria": "3K ohm",
        "Device Performance": "The same"
      },
      "Manual Threshold Mode": {
        "Acceptance Criteria": "0.2 ohm/1000 ohm (0.02%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
        "Device Performance": "0.2 ohm/1500 ohm (0.013%) to 5 ohm/1000 ohm (0.33%) at 20 BPM"
      },
      "Automatic Threshold": {
        "Acceptance Criteria": "0.35 ohm/1000 ohm (0.035%) to 5 ohm/1000 ohm (0.5%) at 20 BPM",
        "Device Performance": "The same"
      },
      "Alarm Settings": {
        "Acceptance Criteria": "Low rate: 0 - 150 BPM; High rate: 8 - 150 BPM",
        "Device Performance": "Low rate: 0 - 120 BPM; High rate: 8 - 120 BPM"
      },
      "Apnea Alarm Delay": {
        "Acceptance Criteria": "10 - 90 sec, selectable (default 10 sec.)",
        "Device Performance": "The same"
      },
      "Apnea Alarm Reset": {
        "Acceptance Criteria": "Automatic as defined by System administrator (default 3 breaths)",
        "Device Performance": "The same"
      }
    },
    "DISPLAYED PARAMETERS": {
      "ECG": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      },
      "Heart Rate": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      },
      "Respiration": {
        "Acceptance Criteria": "Yes",
        "Device Performance": "Yes"
      }
    },
    "ALARM INDICATIONS": {
      "ECG": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      },
      "Heart Rate": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      },
      "Respiration": {
        "Acceptance Criteria": "Visual & Sound",
        "Device Performance": "Visual & Sound"
      }
    },
    "DISPLAY FUNCTIONS": {
      "Change ECG Lead Selection": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Display of Arrhythmia Information": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Data Review: Trends": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "Data Review: Tabular": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "User Defined Configuration Setup": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      },
      "User Defined Default Settings": {
        "Acceptance Criteria": "YES",
        "Device Performance": "YES"
      }
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document states that the 12 Lead ECG/Resp. module 'has also been clinically tested and evaluated in a local hospital.' However, it does not specify the sample size of the test set nor the specific country of origin, or if it was retrospective or prospective.",
  "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 in the document.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This information is not provided in the document.",
  "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. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The device's proprietary algorithms for ECG, Respiration, and Invasive Blood Pressure are stated to be 'based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions.' This suggests standalone testing of the algorithms was performed, but specific details of this testing are not provided for the modified device.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the algorithms, 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions' were used. This implies a ground truth based on established clinical examples and likely expert-validated data, though the exact method is not detailed.",
  "8. The sample size for the training set": "The document does not explicitly mention a training set, but refers to algorithms being 'based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases'. The sample size of these databases is not specified.",
  "9. How the ground truth for the training set was established": "The ground truth for the underlying algorithms was established using 'well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions.' The specific methodology for establishing this ground truth (e.g., expert consensus, independent validation) is not detailed for the original databases."
}

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The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, and Pulse Oximetry. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

ENVOY is hospital based, multiparameter patient monitor for monitoring physiological patient vital signs. The ENVOY patient monitor system consists of the following components: Main Processing Unit, Display Unit, Module Rack, Vital Signs Plug-in Modules. ENVOY vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the ENVOY display unit. Vital signs and waveform information are displayed simultaneously on the ENVOY Display Unit. Up to 8 traces can be displayed at any one time. The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. SpO2 and Non-Invasive Blood Pressure Modules use sofware/hardware from vendors whose products already appearing on the USA market. Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, Waveform, Vital Sign Numeric Value, Alarm Status Message. Operation of the ENVOY is accomplished by interaction with front panel controls on the main processor unit. A quick-knob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is display. ENVOY is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, or life sustaining device; nor is it implantable and therefore sterility is not a consideration.

This submission K974510 for the ENVOY Patient Monitor describes various validations against industry standards and the manufacturer's design specifications for different physiological parameters. However, it does not provide a table of acceptance criteria with corresponding reported device performance values in a structured format that can be easily extracted for all parameters. It also lacks detailed information on studies concerning AI assistance, multi-reader multi-case studies, or specific AI algorithms.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a single, comprehensive table outlining acceptance criteria and reported device performance for all vital signs. Instead, it describes general compliance with standards and internal design specifications.

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

• Sample Size for Test Set: Not explicitly stated in this summary. The text mentions "Simulated inputs were used to test the vital signs monitored by the ENVOY" and "Simulated patient waveforms were generated using a DNI Navada Inc. 217A Patient simulator and Mennen Medical simulators." For NIBP and Pulse Oximetry, it refers to "clinical trials" in "Part 8" but doesn't detail the sample size or provenance in this summary.
• Data Provenance:
  • Simulated Data: For general vital signs (ECG, Respiration, Invasive BP), "proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions."
  • Clinical Data: For NIBP and Pulse Oximetry, "clinical validation studies" are mentioned, with results in "Part 8." The country of origin and whether data was retrospective or prospective is not specified in this summary.

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

• The document does not mention the use of experts to establish ground truth for the test set explicitly. The ground truth for simulated inputs would be the known parameters set on the simulators. For the clinical studies (NIBP, Pulse Oximetry), the "ground truth" would typically come from reference devices or expert-interpreted data, but details are not provided in this summary.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method for the test set.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study is not indicated or described in this document. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device for human interpretation improvements in the context of MRMC studies.

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

• Yes, the core of the validation described for ECG/Heart Rate and "other Vital signs" (excluding SpO2 and NIBP modules that use vendor software/hardware) implicitly involves standalone algorithm performance. The device's "proprietary algorithms and software" for ECG, Respiration, and Invasive Blood Pressure were tested using simulated inputs. The performance for these parameters against AAMI/ANSI standards (for ECG/HR) and Mennen Medical's Design specifications (for others) indicates a standalone evaluation.
• It's important to note that "standalone" here refers to the device's algorithms processing data and displaying results without human intervention in the processing itself, which is standard for patient monitors. However, the clinical use always involves a human-in-the-loop (healthcare provider) to interpret the displayed information.

7. The Type of Ground Truth Used

• For ECG/Heart Rate, Respiration, Invasive BP: The ground truth came from "Simulated patient waveforms generated using a DNI Navada Inc. 217A Patient simulator and Mennen Medical simulators," and "well known and accepted data bases." This is a form of simulated data/known input ground truth.
• For Non-Invasive Blood Pressure and Pulse Oximetry: These parameters underwent "clinical validation studies" and their results are in "Part 8," implying reference device comparisons (e.g., against an established, accurate NIBP device or pulse oximeter) or potentially directly measured physiological data. The summary doesn't specify if it was pathology, outcomes data, or expert consensus for these clinical trials. Given the nature of vital sign monitoring, it's most likely comparison against a gold-standard measurement.

8. The Sample Size for the Training Set

• The document does not specify a sample size for a "training set." The proprietary algorithms for ECG, Respiration, and Invasive Blood Pressure were "based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases." This suggests the algorithms were likely developed and refined (trained/tuned) using these historical "data bases," but the size of these databases is not provided. Modern AI/ML terminology like "training set" might not have been standard practice in medical device submissions in 1997.

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

• The document states that the proprietary algorithms were "based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions."
• This implies the ground truth for these "data bases" was established through:
  • Reference device comparison: Likely, the older Mennen Medical devices and the data they collected were compared against established, validated reference measurements for physiological parameters and artifact detection.
  • Expert knowledge/manual annotation: For "waveform artifact," it's highly probable that experts (e.g., cardiologists, intensivists) annotated or identified these artifacts in the "well known and accepted data bases."
  • The exact methodology for establishing ground truth for these historical "data bases" is not detailed in this summary.

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