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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.

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

• Sample Size: The document refers to "various performance tests" and "extensive safety and performance testing" but does not specify the sample size for these tests.
• Data Provenance: Not explicitly stated, but given that the manufacturer is Mennen Medical Ltd. in Israel, it is likely that parts of the testing were conducted there. The document mentions "Safety testing and EMC testing were performed by an independent testing laboratory," but the location of this laboratory or the origin of the data is not provided. It's unclear if the testing involved real patient data (prospective or retrospective) or simulations/phantoms.

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

• This information is not provided in the document. The testing described focuses on technical performance specifications rather than clinical accuracy determined by experts.

4. Adjudication Method for the Test Set

• This information is not provided in the document. The testing described appears to be objective measurements against technical specifications rather than interpretations requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through technical specifications and performance testing, not on comparing reader performance with or without AI assistance. The EEG module itself does not perform AI-driven interpretation requiring human-in-the-loop studies.

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

• Yes, a standalone study of the device's technical performance was done. The document states, "The Envoy EEG module has been subject to extensive safety and performance testing. Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications." This describes the algorithm/device-only performance against its design specs. The EEG module described is a data acquisition and display device, not an AI-driven interpretive algorithm in the modern sense.

7. The Type of Ground Truth Used

• The "ground truth" for the performance testing described appears to be technical specifications and established engineering standards (e.g., precise voltage measurements, frequency response curves, noise levels, impedance measurements). For the safety and EMC testing, the ground truth was compliance with IEC standards (60601-1, 60601-1-2, 60601-2-26). There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the device's functional performance.

8. The Sample Size for the Training Set

• Not applicable / Not provided. The Envoy EEG module is described as a physiological patient monitor module that converts analog EEG signals into digital data for display. It does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense for algorithm development.

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

• Not applicable / Not provided. As mentioned above, a "training set" doesn't appear to be relevant for this type of device.

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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 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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