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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, 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.

ENVOY EtCO2 is a hospital based module, for monitoring EtCO2 physiological patient vital signs.

ENVOY vital signs EtCO2 module acquires vital signs data from the patient, and displays the patients waveform and alarms indication on the ENVOY display unit. This information is displayed simultaneously on the ENVOY Display Unit.

All processing and alarm determination for EtCO2 is made using Pryon technology based on currently marketed Pryon monitoring devices.

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.

Selection of the EtCO2 functions 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.

The provided document is a 510(k) summary for the MENNEN MEDICAL LTD. ENVOY Patient Monitor with an EtCO2 module. It outlines the device's description, indications for use, and a summary of its validation, focusing on substantial equivalence to predicate devices rather than detailed acceptance criteria against specific performance metrics for the EtCO2 module itself. Therefore, much of the requested information about acceptance criteria and a specific study proving the device meets them directly is not present in the provided text.

Based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for the EtCO2 module's performance (e.g., accuracy, precision) or specific reported performance values against such criteria. Instead, it focuses on functional substantial equivalence to predicate devices and general safety and effectiveness based on design and software validation.

The "Displayed Parameter Message" and "Alarm Indication" table suggests functional equivalence for displaying and alarming on various EtCO2 related parameters between the ENVOY and the MERCURY, but these are not performance metrics.

The document states that the ENVOY EtCO2 was "tested against Mennen Medical's Design Specifications," and "Simulated inputs were used to test the vital signs monitored by the ENVOY." It also mentions testing "against voluntary industrial standards where appropriate, and Mennen Medical design standards where appropriate, or where industrial standards did not exist." However, the specific quantitative acceptance criteria and the numerical results of these tests for EtCO2 performance are not provided.

Study Information

The document describes a validation study, but it lacks the detail typically found in a clinical or performance study report.

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

   • Test Set Size: Not explicitly stated. The validation used "simulated inputs" and "defined gas concentrations of CO2" for the EtCO2 module. This suggests a laboratory-based test with various CO2 concentrations rather than a patient-based test set, and therefore, typical "patient sample size" is not applicable in the usual sense.
   • Data Provenance: The testing was done internally by Mennen Medical. The nature of "simulated inputs" and "defined gas concentrations of CO2" indicates lab data rather than retrospective or prospective patient data from a specific country.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the "simulated conditions" was "defined gas concentrations of CO2," which would be established by the precise calibration of the gas mixing equipment, not by clinical experts.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no expert review or clinical adjudication is described for establishing ground truth in this type of simulation-based testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a patient monitor, not an AI-assisted diagnostic tool requiring human reader interpretation, nor does it describe human-in-the-loop performance improvement.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the validation described appears to be a standalone performance assessment of the EtCO2 module against simulated inputs and design specifications. The focus is on the device's ability to accurately measure and display EtCO2 levels.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): "Defined gas concentrations of CO2" for software validation. This is a controlled, objective physical ground truth established by calibrated equipment.

7. The sample size for the training set: Not applicable. This document describes a traditional medical device validation using engineering and software testing, not a machine learning or AI algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this device's validation as described.

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The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, whose prime function is the acquisition and display of vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Cathlab is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats. The system has a UNIX Sun Solaris 2 (Ultra 5 computer) that utilizes powerful, real-time software to control the system operation and to process the vital patient sign data measurements acquired from the Physiological Front End or entered manually at the keyboard. The Thermal Array Chart Recorder provides a continuous recording of all monitored vital signs, patient ID, time and date during the procedures. A Laser Printer is provided in addition to the Chart Recorder in the central console. This provides print-outs of textual and graphical summaries of all patient data and catheterization procedures.

This document is a 510(k) summary for the Mennen Medical LTD. Horizon 9000 WS Computerized Catheterization Laboratory. It describes the device's function and its substantial equivalence to a previously cleared device. However, this document does not contain information about specific acceptance criteria or study results demonstrating that the device meets such criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The provided text is a regulatory submission for premarket notification (510(k)). Its primary purpose is to establish substantial equivalence to a predicate device, not to detail specific performance studies with acceptance criteria. It states that "None promulgated" for Performance Standards, indicating that the FDA had not issued specific performance standards for this type of device at that time.
• Focus on Substantial Equivalence: The document highlights the device's capabilities and compares them to a predicate device (Horizon 9000 WS - K 940415) cleared in 1995. The FDA's letter (Page 6) confirms that they "reviewed your Section 510(k) notification... and have determined the device is substantially equivalent." This means the device is considered as safe and effective as a legally marketed predicate device, primarily based on its specifications and intended use, not necessarily independent performance studies against defined acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details because that information is not present within the provided text.

To answer your questions, the following information would typically be found in a detailed device validation study report, which is usually part of a more extensive submission, but not always summarized in the publicly available 510(k) summary:

1. A table of acceptance criteria and the reported device performance: Would need specific performance claims (e.g., accuracy of heart rate measurement within X BPM, blood pressure measurement within Y mmHg) and the results of tests demonstrating these.
2. Sample size used for the test set and the data provenance: Would need details on how many patients or data points were used for testing, and if the data was collected prospectively, retrospectively, or from specific geographies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a device primarily measuring physiological parameters. Ground truth for parameters like heart rate or blood pressure would come from other validated measurement devices, not expert consensus interpretation.
4. Adjudication method: Not applicable for this type of device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Highly unlikely for a a data acquisition and display system. MRMC studies are typical for image interpretation devices where human readers interpret medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone system for data acquisition and display. Its performance would be evaluated on its ability to accurately acquire and display physiological data.
7. The type of ground truth used: For physiological measurements, ground truth would typically be established by simultaneously using a highly accurate, reference standard measurement device (e.g., highly calibrated pressure transducers for blood pressure, gold-standard ECG machines for heart rate).
8. The sample size for the training set: Not applicable for this type of device. Training sets are relevant for AI/ML algorithms that learn from data. This device is described as a "computerized laboratory" using "real-time software to control the system operation and to process the vital patient sign data measurements," implying programmed functionality, not machine learning.
9. How the ground truth for the training set was established: Not applicable for this type of device.

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ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

The Ensemble Central Station is able to display the signals that are transmitted to it by the patient monitor to which it is connected via the communication network.

The document provided is a 510(k) premarket notification for the Mennen Medical ENSEMBLE Physiological Monitoring System, Central Station Display Terminal. It establishes substantial equivalence by comparing the new device to existing predicate devices (Mennen Medical ENVOY and HORIZON XL Patient monitors). This type of submission generally does not include performance studies with detailed acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC comparative effectiveness studies in the same way a de novo or PMA submission might for novel AI/ML devices.

The information primarily focuses on demonstrating that the new Central Station performs similarly to previous versions in terms of displaying physiological parameters and alarm indications. The "equivalency statement" column acts as the "reported device performance" in this context, asserting that the new device performs identically or similarly in its function.

Given the nature of the document, many of your requested fields are not directly applicable or are not explicitly stated.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the ENSEMBLE Physiological Monitoring System, Central Station Display Terminal, when connected to the Mennen Medical ENVOY patient monitor, performs equivalently to when it is connected to the Mennen Medical HORIZON XL patient monitor across various functionalities.

Study Information:

1. Sample size used for the test set and the data provenance: Not explicitly stated. This type of submission relies on demonstrating functional equivalence through comparison to legally marketed predicate devices, rather than a clinical trial with a specific test set of patients or data. The "test" here is the comparison of features, not a performance evaluation on clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., from expert annotations or pathology) is not discussed in this device's 510(k) submission.

3. Adjudication method for the test set: Not applicable.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a central station display system, not an AI/ML diagnostic or assistive tool, and thus MRMC studies are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's function is to display data from patient monitors; it does not contain a standalone algorithm for diagnosis or interpretation.

6. The type of ground truth used: Not explicitly defined in terms of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is implicitly the established and legally marketed functionality of the predicate devices. The claim is that the new configuration (ENSEMBLE with ENVOY) performs equivalently to the existing configuration (ENSEMBLE with HORIZON XL), where the existing configuration's performance is the reference.

7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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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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ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

ENSEMBLE is hospital based, multi-patient, multi-parameter display terminal. As such, it is a component in a physiological patient vital signs monitoring system.

A system consists of any of the several possible combinations of the following components: Bedside Devices

HORIZON XL patient monitor, and/or 219 TELEMETRY RECEIVER/TRANSMITTER with NS-7, (K911616, and K895395, respectively) Ethernet™ Communication Network Documentation Peripherals (Chart Recorders and Laser Printers), and

ENSEMBLE Central Station Monitor.

ENSEMBLE acquires patient vital signs, waveforms and alarm indications from Mennen Medical HORIZON XL and 219 TELEMETRY systems. All processing and alarm determination is made in these "bedside devices", using proprietary algorithms and software contained therein. Processed information is communicated from the bedside devices to one or more ENSEMBLE Central Station Monitors by the Mennen Medical ENSEMBLE system Ethernet™ network. If documentation is requested, information is transmitted to the appropriate Documentation Peripheral, using the same network.

Although ENSEMBLE does not make alarm determinations, it does provide users with a remote interaction capability, allowing users to make changes to both parameter and alarm settings in the remote bedside devices. Similarly, ENSEMBLE users have a remote interactive capability to initiate recordings or printing of patient information and waveforms.

Vital signs and waveform information from up to 12 patients are be displayed simultaneously on an ENSEMBLE Central Station Monitor. Information from each individual patient is presented in a separate portion of the display. Each patient display area includes: Patient Name, Assigned Location (room), Primary Vital Sign Name, Value & Alarm Limits (nominally Heart Rate), Primary Waveform (nominally ECG), Secondary Vital Sign Numeric Data, Alarm Status Messages, and a dedicated "soft key" for recording waveforms. Software configurations allow more than one waveform or parameter to be displayed for each patient.

Primary operation of the ENSEMBLE is accomplished by a desktop mouse. A standard computer keyboard is used for manual entry of alphanumeric information. An optional touchscreen is available for users who prefer to use a touchscreen. Alternative "desktop devices", such as trackball and light pen, are also available as options. For large installations, with several ENSEMBLEs intended for a single user, the system may be configured to enable one keyboard and one mouse to control up to eight individual ENSEMBLE computers.

ENSEMBLE is a reusable, software driven, central station display terminal, 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. ENSEMBLE complies with UL 544, ANSI Safe Current Limits for Electromedical Apparatus, and FDA MDS-201-0004 voluntary standards. ENSEMBLE is not a kit, does not contain any drug or biological products and is for prescription use,

The provided text is a 510(k) Summary for the ENSEMBLE Central Station Monitor. This document describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on regulatory approval rather than a detailed scientific study with acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted directly from this document. The document primarily focuses on demonstrating regulatory compliance and substantial equivalence.

Here's an explanation based on the limited information found in the document, and what is missing:

The document states:
"ENSEMBLE complies with UL 544, ANSI Safe Current Limits for Electromedical Apparatus, and FDA MDS-201-0004 voluntary standards." and "AAMI/ANSI ES11 Safe Current Limits for Electromedical Devices AAMI/ANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms UL-544"

This indicates that the "acceptance criteria" are likely based on adherence to these voluntary standards for electrical safety and performance of cardiac monitors. However, no specific performance metrics (e.g., accuracy of heart rate measurement, alarm response time) are provided in the way requested in the prompt.

Missing Information:

• A table of acceptance criteria and reported device performance: No such table is present. The document mentions compliance with standards but does not quantify performance against specific criteria.
• 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: 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: Not mentioned. The device is a display terminal, not an AI-driven diagnostic tool in the sense of the prompt.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device is a "multi-patient, multi-parameter display terminal" and explicitly states, "All processing and alarm determination is made in these 'bedside devices', using proprietary algorithms and software contained therein." ENSEMBLE acquires information and displays it.
• The type of ground truth used: Not applicable in the context of the provided document, as it describes a display device that presents data processed by other "bedside devices."
• The sample size for the training set: Not applicable and not mentioned, as this is not an AI algorithm development study.
• How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of available information related to "acceptance criteria" and "study":

• UL 544
• AAMI/ANSI ES11 Safe Current Limits for Electromedical Devices
• AAMI/ANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms
• FDA MDS-201-0004 |
  | Reported Device Performance | The document states the device "complies" with the listed standards. No specific performance metrics (e.g., accuracy, sensitivity, specificity) against these standards are provided for the ENSEMBLE specifically. The device is a display terminal; processing and alarm determination happen in "bedside devices." |
  | Study that proves device meets acceptance criteria | The document is a 510(k) summary, aiming to demonstrate substantial equivalence to predicate devices (MENNEN MEDICAL COMPREHENSIVE CENTRAL STATION (K892066) and HEWLETT-PACKARD M2360A WAVEVUE CENTRAL MONITOR (K921014)). It implies that compliance with the voluntary standards, along with the description of the device's functionality and safety features, constitutes the evidence for meeting "acceptance criteria" for regulatory clearance. It does not describe a scientific study with a test set, ground truth, or statistical analysis. |

In conclusion, the provided document is a regulatory submission (510(k) Summary) that outlines the device's characteristics and its substantial equivalence to predicate devices under existing standards. It does not contain the detailed scientific study information, ground truth methods, or specific performance metrics typically found in a clinical study report for an AI/ML-driven diagnostic device.

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