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Menntor X7 is intended for use as a multi-parameter physiological patient monitoring system.

The Menntor X7, is a modular monitor with a Multi Parameter Module (MX57, MPM) that can monitor ECG/heart rate, invasive blood pressures , temperature, pulse oximetry, respiration, non-invasive blood pressure, and Cardiac Output

The Menntor X7 can also monitor EtCO2, Spirometry and EEG, and display aEEG.

The MPM (MX57) is equipped with a battery and can continue monitoring it's vital sign when out of the host Menntor X7

This effectively allows the Menntor X7 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.

Functions include display of multi-parameter waveforms, vital signs, alarm & status messages.

The Mennen Medical Menntor X7 is intended for sale as a system for monitoring and recording patient information on any in-hospital application requiring patient monitoring.

The following are examples of intended clinical applications:

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

*The Intended Use of the Menntor X7 as indicated above is same as the Indications For Use.

The Menntor X7 is a modular multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical VitaLogik 6000/6500 and Envoy monitors, with integrated display screen. It is part of the Envoy/VitaLogik Monitor family and runs on same software versions.

In general, the Menntor X7 has the same functions, similar intended use and technology as the other members of the Mennen Medical monitor family.

The Menntor X7 uses identical display format and patient data as does the VitaLogik 6000/6500 monitor. The Ensemble central station and the Enguard remote monitor can both view the Menntor X7 as well as the other members of the family: VitaLogik 6000/6500, VitaLogik 4000/4500, VitaLogik 5000/ 5500 and Envoy.

The Menntor X7 bedside patient monitor consists of MX57 - Multi Parameter plug in Module, (MPM), two additional single parameters plug in modules, a main processing unit, and an integrated color monitor with optional touch screen. The front end electronics incorporated in the MPM has same hardware and software as VitaLogik 6000/6500 . The input connectors are incorporated in the side panel of the MPM.

The MPM (MX57) has an optional 5.7" display, that enables the MPM to continue monitoring when taken out of the Menntor X7 host.

The Menntor X7 monitor presents vital signs in the same way and the same GUI (Graphic User Interface) as does the VitaLogik 6000/6500 monitor.

The Menntor X7 can acquire the following physiological signals of the patient:

· ECG - Waveform. Arrhythmia and numeric values of Heart Rate, and ST

• · Blood Pressures Waveform and numeric values of, Diastole and Mean pressure
• · Temperature As a numeric value in Cº or Fº
• · SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
• · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp
• · EtCO2 EtCO2, inCO2 and Respiration Rate
• · Spirometry
• · EEG and aEEG.

The provided document is a 510(k) premarket notification for the Menntor X7 patient monitor. It focuses on demonstrating substantial equivalence to predicate devices (VitaLogik 6000/6500 and Envoy monitor with Spirometry module) rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials or standalone performance evaluation against a large, adjudicated dataset.

This type of submission relies heavily on comparisons of technical specifications and functional equivalence to existing cleared devices. Therefore, many of the requested details regarding acceptance criteria, study sample sizes, expert adjudication, and MRMC studies are not present as they are typically associated with de novo submissions or more complex, novel AI/ML device approvals.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Menntor X7 are primarily based on demonstrating equivalence in performance specifications to the predicate devices. The document provides a detailed comparison table (pages 7-8) of various vital signs parameters, listing the specifications of the predicate device (VitaLogik 6000/6500) and stating "Same" for the Menntor X7 if the performance is identical. This "Same" implicitly serves as the acceptance criterion, meaning the Menntor X7 performs at least as well as the predicate for those parameters.

Since the document repeatedly states "Same" for the Menntor X7's performance compared to the predicate, we can construct a table reflecting this. The acceptance criteria are the predicate's performance specifications.

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

The document does not specify a "test set" in the context of labeled patient data for algorithm performance. Instead, it relies on:

• Performance tests using calibrated simulators: "Calibrated simulators were used to confirm the equivalence of each of the monitored Vital signs." (page 16) This means testing was done on the device's ability to accurately read and display signals generated by known, controlled inputs, mimicking physiological signals. The sample size for these simulated tests is not explicitly stated.
• System-level software validation: "At the system level, SW Validation of the performance of the Menntor X7 as compared to the VitaLogik 6000/6500 system was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Menntor X7." (page 16)
• Final performance tests: "Final testing for the Menntor X7 included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Menntor X7." (page 16)
• Electrical Safety and EMC Testing: Performed by an independent lab (page 16).

Since this is a 510(k) for a patient monitor and not a diagnostics AI/ML device, patient data provenance (country of origin, retrospective/prospective) and sample size for a "test set" as one might see in an AI/ML submission are not relevant or provided. The testing is primarily bench testing and software validation against established predicate performance.

3. 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 performance claims in this submission is the known output of calibrated simulators and the established performance specifications of the predicate devices, not expert human readers evaluating patient data.

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

Not applicable. There's no human adjudication of "ground truth" labels/diagnoses as would be the case for an AI/ML diagnostic algorithm.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a patient physiological monitor, not an AI-assisted diagnostic tool. Its primary function is to acquire, process, display, and store vital signs. There is no "human reader" in the sense of interpreting complex medical images or data that the device then assists.

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

The device's performance is inherently "standalone" in terms of its ability to acquire and process physiological signals from a patient. The "study" proving this is the direct comparison of its technical specifications and performance in bench testing against the predicate device's cleared specifications, as detailed in the comparison tables.

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

The ground truth used for verifying the Menntor X7's performance is established by:

• Calibrated Simulators: For vital signs acquisition and display (e.g., generating a known ECG waveform or blood pressure reading to ensure the device accurately measures and displays it).
• Predicate Device Specifications: The established, legally marketed performance characteristics of the VitaLogik 6000/6500 and Envoy Spirometry module serve as the benchmark for equivalence.
• Industry and Safety Standards: Compliance with standards like IEC 60601 series, which specify performance and safety requirements for medical electrical equipment.

8. The sample size for the training set

Not applicable. This is a traditional medical device (patient monitor), not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's design and verification is based on established engineering principles, physiological accuracy requirements for patient monitoring, and compliance with recognized medical device standards.

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The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

The CerebraLogik consists of a dual channel EEG amplifier that is put near the monitored patient. The amplifier is connected, using an interface cable, to a Mennen Medical patient monitor via the UIM input of the monitor. The monitor has display options for both real time EEG and history of Amplitude Integrated EEG - aEEG. The monitor stores both EEG and aEEG signals for the duration of the EEG monitoring.

The provided documentation describes the CerebraLogik aEEG device, intended to monitor brain activity by acquiring EEG signals and displaying them as Amplitude Integrated EEG (aEEG). The submission is a Traditional 510(k) for the addition of this aEEG functionality to Mennen Medical's existing VitaLogik monitor family, asserting substantial equivalence to the Olympic CFM 6000 (K031149).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olympic CFM 6000) through bench testing and an animal study, comparing device characteristics and output patterns. The reported "performance" is that the CerebraLogik produced "same aEEG graphs" and "same aEEG pattern" as the predicate device under specific testing conditions.

Here's a table summarizing the comparative characteristics and the reported findings for direct comparison points:

Note: The acceptance criteria are implicitly drawn from the predicate device's specifications and the expectation that the new device should perform equivalently or better without raising new safety/effectiveness concerns.

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

• Bench Test (Simulated Use): EEG signal from one Grass EEG Simulator model EEG SIM. The signal was inserted in parallel to both devices for periods of 3 hours. Data provenance for the simulated signal is not explicitly stated but implies a synthetic source, not patient data.
• Animal Study: EEG signals from anesthetized piglets. The number of piglets is not specified but it states "piglets" (plural). The recordings were made in parallel on both devices for periods of 3 and 7 hours. Data provenance is an animal model, not human patients. This data is retrospective for the purpose of the study as it was collected for comparison.

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 human experts to establish ground truth for either the bench test or the animal study. The "ground truth" seems to be the output of the predicate device itself, with the new device's output being compared against it.

4. Adjudication Method for the Test Set

Since human experts were not used to establish ground truth or compare outcomes, there was no adjudication method described. The comparison was based on direct observation of "same aEEG graphs" and "same aEEG pattern" by the study's researchers/engineers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on technical equivalence and functional comparison of the device's output to a predicate device and simulated/animal signals, not on human reader performance with or without AI assistance.

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

The studies described are essentially standalone performance evaluations of the device's signal acquisition and processing capabilities. The device's output (aEEG graphs/patterns) was compared directly to the predicate device and the input signals, without a human in the loop affecting the device's generation of the aEEG display. The product itself, CerebraLogik aEEG, is a standalone module integrated into a monitor, providing processed EEG data for clinicians to interpret, but its output generation is algorithm-only.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the bench test, the ground truth was effectively the known electrical signal from the Grass EEG Simulator and the output of the predicate device (Olympic CFM 6000) when fed this signal.
• For the animal study, the ground truth was the physiological EEG signal from anesthetized piglets, and the comparative output of the predicate device (Olympic CFM 6000) under the same conditions.

In both cases, it's a form of empirical comparison against a known input or a legally marketed predicate device's output, rather than an expert consensus, pathology, or outcomes data from human patients.

8. The Sample Size for the Training Set

The document does not mention any training set. The CerebraLogik aEEG module appears to be based on fixed algorithms for filtering, rectifying, and compressing EEG signals, rather than a machine learning model that would require a distinct training set. The descriptions focus on the implementation of these algorithms and their output comparison, not on their development or training.

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

Since no training set is mentioned and the device's technology appears to be based on established signal processing rather than machine learning, this question is not applicable based on the provided text.

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The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures, and EtCO2.

BP waveforms from different heart and vascular sites, are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform, gradients and FFR, can be stored, recorded, analyzed and presented in a variety of report formats.

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The system has a computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard. The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display. The Central System contains the following main devices: Computer, Two local LCD displays, Video line driver, AC Power Unit, Laser printer, Hub, Modem. FFR is a mode that uses two invasive pressure inputs. Pa - Proximal pressure measured with external pressure transducer at the artery or aorta. and Pd - Distal pressure measured with a pressure wire sensor in the coronary arteries across lesion. Mean pressures are calculated and the ratio between the means Pd/Pa is calculated and displayed.

The provided document describes the Mennen Medical Horizon XVu with the addition of Fractional Flow Reserve (FFR) measurement, submitted as a traditional 510(k) for device modification (K123792).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table between the predicate device (Volcano ComboMap) and the modified Horizon XVu with FFR, particularly focusing on input circuit parameters and measurement capabilities. While it doesn't explicitly state "acceptance criteria" as a pass/fail threshold, it presents a comparison of specifications.

Note: The document emphasizes that "the basic amplifier specifications are the same for the Horizon XVu (FDA approved) and the Horizon XVu with FFR." The key "reported device performance" is that the Horizon XVu with FFR can successfully display the FFR waveform and value, and its FFR measurement capabilities are comparable to the predicate. The provided table details the technical specifications that are meant to show this comparability and thus meet the implicit acceptance criteria of substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

The document states: "At the system level, SW Validation of the performance of the Horizon XVu with 9600PT580/585 as compared to the Horizon XVu Cathlab system, was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Horizon XVu."

It also mentions: "Final testing for the Horizon XVu system included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Horizon XVu system."

• Sample Size for Test Set: The document does not specify a sample size for the test set. It refers generally to "system level, SW Validation" and "Final Testing" without providing numbers of test cases, patients, or data points.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. The validation and testing appear to be internal to Mennen Medical, conducted as part of their software and system validation process.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth. The testing mentioned appears to be focused on technical performance and comparison to specifications rather than clinical ground truth established by external experts.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. The validation seems to rely on internal test plans and procedures, likely against predefined technical specifications.

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

No MRMC comparative effectiveness study is mentioned. The submission is for a device modification (addition of FFR measurement capability) and focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and functionality, not on human-in-the-loop performance metrics or improvements with AI assistance.

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

The testing described appears to be standalone in nature, focusing on the system's ability to acquire, process, calculate, and display FFR and other vital signs according to its specifications, without explicitly evaluating human interaction or diagnostic decisions. The FFR calculation itself is an algorithm. However, no specific "algorithm only" performance metrics (e.g., sensitivity, specificity, AUC) are provided for the FFR calculation; rather, it focuses on the accuracy of the underlying pressure measurements. The "Measurement accuracy" for FFR is specified for the pressure measurements: "+/- 2 mmHg, or +/- 2%, whichever is greater, exclusive of transducer." This is a standalone performance metric for the pressure measurement component of the FFR calculation.

7. The Type of Ground Truth Used

The ground truth used for the device's FFR capability is based on the accuracy of pressure measurements and the ratio calculation (Pd/Pa) as compared to predefined technical specifications. The document states a measurement accuracy of "+/- 2 mmHg, or +/- 2%, whichever is greater, exclusive of transducer." This implies that the ground truth for evaluation is derived from calibrated pressure inputs and the expected mathematical outcome of the FFR ratio. It is a technical ground truth rather than a clinical one established by pathology or patient outcomes.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device is a "programmable diagnostic computer" with added FFR measurement, not an AI/ML-based device that typically undergoes a training phase with a distinct training set. The FFR calculation is based on established physiological principles and algorithms, not learned from data in the way AI models are trained.

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

Since there is no mention of a training set for an AI/ML model, there is no discussion of how ground truth for a training set was established. The FFR calculation is a deterministic algorithm based on real-time pressure measurements.

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VitaLogik 6000/6500 is intended for use as a multiparameter physiological patient monitoring system.

The VitaLogik 6000/6500 can monitor ECG/heart rate, invasive blood pressures , temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2.

This effectively allows the VitaLogik 6000/6500 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 VitaLogik 6000/6500 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

Not Found

I am sorry, but the provided text does not contain the detailed information needed to construct the table of acceptance criteria and the comprehensive study description you requested. The document is a 510(k) clearance letter for a patient monitor (VitaLogik 6000/6500), which declares its substantial equivalence to predicate devices and lists its intended uses.

It does not include:

• Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
• Details of a performance study (like test set size, data provenance, expert qualifications, adjudication methods, MRMC study results, or standalone algorithm performance).
• Information about the training set size or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

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The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.

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 prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Horizon XVu system consists of a Front End unit (CFE) and a Central system. The CFE acquires, processes, and converts vital signs from the patient into digital signals and sends them to the central system for process and display. The central system contains a computer workstation, displays, printer, and other components. The system is capable of acquiring and displaying ECG/Heart Rate, ICECG, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature.

The provided text describes a 510(k) submission for a modification to the Mennen Medical Horizon XVu device, specifically adding an Intra-Cardiac ECG (ICECG) measurement option. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving new clinical effectiveness. Therefore, some of the requested information, particularly related to clinical study design (sample size, expert ground truth, adjudication, MRMC studies) for new effectiveness claims, is not detailed in this type of regulatory document.

However, based on the provided text, we can extract information regarding acceptance criteria (implied by the comparison to a predicate device) and the verification/validation activities performed.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified Horizon XVu with ICECG (960-OPT-600) are implicitly defined by its substantial equivalence to two predicate devices:

1. Horizon XVu (K081484): For the overall Cathlab system functionality, ensuring that the addition of ICECG does not negatively impact existing vital sign acquisition and display.
2. Mennen Medical EMS-XL cardiac electrophysiology system (K071348): Specifically for the ICECG measurement capabilities, ensuring its performance is comparable to the ICECG functionality of the EMS-XL.

The device performance is reported by comparing its characteristics directly to these predicate devices.

Study Details

The provided document describes verification and validation activities rather than a traditional clinical study with a test set of patient cases. This is typical for a 510(k) modification aiming to demonstrate substantial equivalence, especially when the modification is primarily technological (adding a new parameter that leverages existing technology).

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

   • Test set: Not applicable in the sense of a clinical patient cohort. The testing described is system-level and software validation.
   • Data provenance: Not specified other than "performance tests designed to ensure that the device meets all functional requirements and performance specifications". It is implied that this testing was internal to Mennen Medical or conducted by approved testing bodies. The document does not mention data from human subjects or a clinical test set for the ICECG functionality.

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

   • Not applicable/Not specified. Ground truth in this context would refer to the established performance requirements of the predicate devices and industry standards. No mention of human expert adjudication for a "test set" of cases.

3. Adjudication method for the test set:

   • Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. The submission is for a device modification to add a measurement parameter, not a new diagnostic algorithm requiring comparative effectiveness against human readers.

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

   • The document implies that the performance tests were for the device's ability to acquire and display the ICECG signal correctly, which is a "standalone" or intrinsic performance evaluation of the hardware and software. The "stand-alone" performance criteria are tied to the specifications of the predicate EMS-XL system's ICECG measurement.

6. The type of ground truth used:

   • The ground truth for this submission is based on engineering specifications and established performance characteristics of the predicate devices (Horizon XVu and EMS-XL), as well as compliance with electrical safety and EMC standards (e.g., IEC 60601 series). The claim is that the new ICECG functionality performs equivalently to an already cleared device, and the overall system still performs equivalently to the original cleared Horizon XVu.

7. The sample size for the training set:

   • Not applicable. This is not a submission for an AI/ML algorithm that requires a training set of data. The "software" changes relate to displaying and controlling existing vital signs and the new ICECG, implying configuration and integration rather than learning.

8. How the ground truth for the training set was established:

   • Not applicable (as there is no training set for an AI/ML algorithm).

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The Mennen Medical VitaLogik BIS interface 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 EBG 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 Intended Use of the VitaLogik monitor as indicated above are same as the Indications For Use.

The VitaLogik 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
• BBG
• BIS Interface (new subject of this application)

Main components of the VitaLogik: The VitaLogik system consists of:
(A) a Bed side computer with
(B) Display

(A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals.

The VitaLogik can acquire the following physiological signals of the patient:

• ECG Waveform and measures Heart Rate, ST and Arrhythmia
• Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure
• Temperature As a numeric value in C or F
• SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
• NIBP Systolic, Diastolic and Mean pressure with measuring time stamp
• EtCO2 EtCO2, inCO2 and Respiration Rate
• BIS Index of conciseness and EEG waveform

(B) The Display is used to display the measurement and waveforms, and alarms. With touch screen option it provides also the control functions, replacing the use of hardware keys. 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 VitaLogik is accomplished by interaction with front panel controls. A quickknob 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 displayed.

The VitaLogik 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 VitaLogik monitors the patient's vital sign data derived by the VitaLogik are presented on the monitor as waveform and numeric displays. The VitaLogik acquire vital signs data from the patient, and display their waveforms and alarms indications on the VitaLogik display.

The VitaLogik is not a kit and does not contain any drug or biological products. The BIS Interface of the VitaLogik patient monitor is not sold as a stand alone device, but as part of a multiparameter physiological patient monitoring system (VitaLogik).

In chapter 1, page 1-2 of the VitaLogik Operating Manual, the following Prescription Notice appears: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only"

Functional description of the new VitaLogik BIS Interface:
(Interface to Aspect BISx device cleared in K 040183)

The BIS Interface is used to monitor dual channel EBG 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 VitaLogik monitor.

Here's an analysis of the provided text regarding the VitaLogik Patient Monitor with BIS Interface, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for a device modification, specifically the addition of a BIS Interface to the existing VitaLogik Patient Monitor. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device (Envoy BIS Module). Therefore, the "acceptance criteria" are predominantly framed around matching the specifications and performance of the predicate device, rather than explicit numerical thresholds for clinical outcomes.

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

• Sample Size: The document does not specify a numerical sample size for patients or data used in the performance testing. It refers to "extensive performance testing," "SW Validation," and "Final testing." These are likely internal verification and validation activities rather than a formal clinical study with a defined sample size for statistical inference on patient data.
• Data Provenance: Not specified. Given the nature of a 510(k) for a device modification, the testing likely involved simulated data, test bench measurements, and possibly limited internal clinical evaluations for verification, rather than large-scale prospective clinical trials. The statement that "The performance of the BIS interface was also tested by Aspect Medical as per the attached certificate (part 21)" suggests some level of external validation, but details of that testing are not provided in this document.

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

This information is not provided in the document. The study described focuses on demonstrating technical and functional equivalence to a predicate device, rather than establishing a new clinical ground truth. For a device like a patient monitor, the "ground truth" for the displayed physiological parameters is typically the actual physical measurement itself (e.g., EEG signals, blood pressure, temperature), and the device's accuracy is verified against calibrated instruments or the predicate's output.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of technical equivalence testing described here. Adjudication by experts is typically for subjective assessments or outcomes in clinical studies, which is not the focus of this 510(k) submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study assesses how human readers perform with and without AI assistance, which is not relevant for a device modification involving only an interface to display existing physiological parameters like the BIS Index. The device itself is not an "AI" in the sense of providing diagnostic or interpretive assistance beyond presenting raw and processed physiological data.

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

Yes, a form of standalone testing was done. The VitaLogik BIS Interface itself is essentially an algorithm/hardware combination that:

• Receives data from the Aspect BISx unit.
• Transfers it to the VitaLogik bedside computer.
• Displays and stores the BIS parameter and quality parameters.

The "SW Validation of the performance of the VitaLogik with BIS interface as compared to the Envoy BIS module" and "Final testing for the VitaLogik BIS Interface included performance tests designed to ensure that the device meets all functional requirements and performance specifications" describe tests of the device's ability to accurately process, display, and store the parameters from the BISx, independent of a specific human-in-the-loop clinical outcome study. The comparison to the predicate device is a form of standalone performance assessment against an established benchmark.

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly the output of the Aspect BISx unit and the performance of the predicate Envoy BIS module. The VitaLogik BIS Interface is designed to accurately receive, display, and store the already processed BIS Index and related parameters as calculated by the BISx. The core ground truth for the measurements themselves originates from the BISx's processing of EEG signals. For the interface's performance, the ground truth is whether it accurately reflects what the BISx unit is sending and whether its display/storage matches the established predicate device's capabilities.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The VitaLogik BIS Interface is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. It is a hardware/software interface designed to relay and display data from another cleared device (BISx). Its development involves software engineering and testing against specifications, not machine learning model training.

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

This information is not applicable and not provided, as there is no "training set" for this device modification.

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The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.

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, analyzed and presented in a variety of report formats.

*The Intended Use of the Horizon XVU is same as the Indications For Use as indicated above.

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history.

The Horizon XVu is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature. Heart rate, multi-lead ECG, EtCO2 and BP waveforms from different heart and vascular sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats.

The Horizon XVu is used for activities such as coronary and peripheral endovascular procedures and Angioplasty. The basic steps described above (catheter positioning, site definition/acquisition, analysis and acceptance) are performed as an integral part of these procedures.

The system has a Sun Ultra 25 computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard.

A Laser Printer is provided in the system. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures.

The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs (A) from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Horizon XVu device:

Important Note: The provided document is a 510(k) premarket notification for a device modification. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel clinical study with detailed acceptance criteria and performance metrics for an entirely new device. As such, the document primarily describes the device and its intended use, and explains why the modification does not alter its fundamental safety or effectiveness.

Therefore, the information you've requested regarding specific acceptance criteria, comprehensive study designs, sample sizes, expert qualifications, and detailed performance metrics is largely absent from this particular 510(k) document. The device is being cleared based on its similarity to a previously cleared device (Horizon SE) and the limited nature of the modification (primarily a GUI change).

Despite this, I will attempt to extract and infer what I can from the provided text to address your points, acknowledging where information is not present.

Acceptance Criteria and Device Performance

Due to the nature of this 510(k) (device modification, specifically a GUI change), the document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the way one might expect for a new device's clinical trial results. The "performance" being validated here is primarily that the new GUI does not negatively impact the existing functionalities and performance of the predicate device.

The implicit acceptance criteria for this modification are:

• Functional Equivalence: The Horizon XVu performs all the functions of the Horizon SE.
• Safety Equivalence: The GUI change does not introduce new safety risks.
• Effectiveness Equivalence: The GUI change does not negatively impact the device's ability to acquire, display, store, and analyze patient data effectively for its intended use.
• User Interface Improvement: The new GUI is "more user-friendly" and has a "modern look" with "better contrast and easier user interface."

Study Details (Based on available information)

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

   • Test Set Sample Size: Not explicitly mentioned. Given this is a GUI change to an existing device, a formal "test set" in the sense of a new clinical study with patient data is unlikely to have been conducted for this 510(k). The focus would be on internal verification and validation of the software change.
   • Data Provenance: Not applicable in the context of a new clinical study. The device itself is manufactured in Israel ("Mennen Medical Ltd., 4 Hayarden Street, Yavne, 81228, Israel").

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

   • Not applicable. There is no mention of a "ground truth" derived by experts for a test set in this document, as it's a device modification focused on the user interface and functional equivalence, not a new diagnostic or prognostic tool requiring clinical adjudication.

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

   • Not applicable. No clinical test set or adjudication is described.

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:

   • No. This device is a physiological monitoring system and is not described as having AI capabilities or undergoing an MRMC study for diagnostic effectiveness. It's an information display and management system.

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

   • Not applicable. This is not an algorithm-only device; it's a integrated system for acquiring and displaying physiological data for human interpretation and use in medical procedures.

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

   • Not applicable. No ground truth is described in this context. The "ground truth" for the device's accuracy in measuring ECG, BP, etc., would have been established during the original predicate device clearance (K032997) through calibration and performance testing against reference standards, not through expert consensus on patient data for this GUI update.

7. The sample size for the training set:

   • Not applicable. This document describes a traditional medical device (physiological monitor with a specific GUI), not a machine learning or AI algorithm that requires a "training set" of data.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set is described.

Summary of the 510(k) Scope:

This 510(k) (K081484) is a "Special 510(k)" for a "Device Modification - Horizon XVu." The core premise is that the Horizon XVu is "identical to the Horizon SE Cathlab but with different graphic user interface." The key justification for substantial equivalence lies in the fact that the underlying hardware, signal acquisition electronics (CFE), functions, and protocols were not changed. Only the "GUI view and colors" were modified to improve user-friendliness and provide a modern look. Therefore, the detailed studies and performance metrics typically expected for an entirely new device, or a device with new clinical claims, are not required or presented in this type of submission. The FDA's clearance (JUN 20 2008 letter) confirms that the device is "substantially equivalent" to its predicate, based on this scope.

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VitaLogik 4000/4500 is intended for use as a multiparameter physiological patient monitoring system.

The VitaLogik 4000/4500 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 VitaLogik 4000/4500 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 VitaLogik 4000/4500 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 Intended Use of the Envoy monitor as indicated above is same as the Indications For Use.

The VitaLogik 4000/4500 is a configured multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical VitaLogik 5000/5500 monitor, with integrated display screen. It is part of the Envoy/VitaLogik family and runs on same software versions.

In general, the VitaLogik 4000/4500 has the same functions, intended use and technology as the VitaLogik 5000/5550, the main different between the VitaLogik 4000/4500 and the VitaLogik 5000/5500 is the addition of battery power supply that gives the VitaLogik 4000/4500 same abilities as the VitaLogik 5000/5500 with the ability to use it as a transport monitor. To reduce the power consumption we have also replaced the hard disc memory with a Compact Flash memory.

The VitaLogik 4000/4500 uses identical display and patient data as do the VitaLogik 5000/5500 and Envoy monitors. The Ensemble central station and the Enguard remote monitor can both view the VitaLogik 4000/4500, VitaLogik 5000/ 5500 as well as the Envoy.

The VitaLogik 4000/4500 bedside patient monitor consists of a main processing unit, and an integrated color monitor with optional touch screen.

The front end electronic has same hardware and software as VitaLogik 5000/5500 . The input connectors are incorporated in the side panel of the monitor.

The VitaLogik 4000/4500 monitor presents vital signs in the same way and the same GUI (Craphic User Interface) as does the VitaLogic 5000/5500 monitor.

The VitaLogik 4000/4500 can acquire the following physiological signals of the patient:

• · ECG Waveform and measures Heart Rate, ST and Arrhythmia
• · Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure
• · Temperature As a numeric value in Cº or Fº
• · SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
• · NIBP Systolic, Diastolic and Mean pressure with measuring time stamp EtCO2 - EtCO2, inCO2 and Respiration Rate

The provided text is a Special 510(k) submission for the VitaLogik 4000/4500 patient monitor. Special 510(k)s are used for modifications to a legally marketed device that do not affect its intended use, fundamental scientific technology, safety and efficacy, and do not fall into categories inappropriate for a special 510(k) application.

This means the submission is primarily focused on demonstrating "substantial equivalence" to a predicate device (VitaLogik 5000/5500) rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance metrics for an AI algorithm.

Therefore, many of the requested details, particularly those related to AI algorithm performance, ground truth, expert consensus, and sample sizes for training/test sets as would be found in an AI/ML device submission, are not applicable to this document.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) are provided in this document as it's a Special 510(k) for device modification, not a de novo clearance requiring clinical performance studies against specific endpoints. The device is deemed substantially equivalent to its predicate. The acceptance is based on the determination that the changes:

• Do not affect the intended use of the VitaLogik 5000/5500.
• Do not alter the fundamental scientific technology of the VitaLogik 5000/5500.
• Do not affect the safety and efficacy of the VitaLogik 5000/5500.
• Do not fall within the type of change inappropriate for a special 510(k) application.

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

This information is not applicable as the submission is for a hardware and minor software modification to an existing patient monitor, not an AI/ML algorithm that would undergo testing with a clinical test set. The justification relies on the substantial equivalence to the predicate device, which would have undergone performance testing for its original clearance.

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 applicable. Ground truth establishment by experts for a test set is relevant for AI/ML performance evaluation, which is not the focus of this Special 510(k).

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

This information is not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert ground truth labels for AI/ML validation, which is not present here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which is not relevant for this device submission.

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

This information is not applicable. This submission is for a patient monitor, not an AI algorithm.

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

This information is not applicable. Ground truth is not established in this Special 510(k) submission.

8. The sample size for the training set

This information is not applicable. There is no mention of an AI/ML training set in this submission.

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

This information is not applicable. There is no mention of an AI/ML training set or its ground truth establishment in this submission.

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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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EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded.

The system allows the user to monitor, display and record the signal data.

The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

The EMS-XL Cardiac Electrophysiology System consists of a software driven, multichannel amplifier and stimulator that are connected to a computer.

Input signals include 12 lead surfaces ECG, two Blood pressure channels and 18 or 50 channel intra-cardiac ECG.

The signals are digitized and sent to the computer for analysis, display and storage.

Signals are displayed with sweep speeds of 25 to 300mm/sec in either predefined or customized configurations.

The system consists of a computer, Front end amplifiers with integrated stimulator.

Two display screens, one used for Real Time signal display and the other for Non real Time display for analysis and review and playback of stored signals.

A Laser printer is used to print surface and intra-cardiac ECG and a CD or DVD is used for archive of signals.

The two display screens are used to show the signals. The real time display, RT, shows the real time signal waveforms. Each waveform channel is color-coded for easy identification. The non real time display, NRT, serves as a Review monitor allowing the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

The stimulator is computer controlled and provides basic stimulation rate plus up to 4 stimulations delayed after the basic stimuli. Stimulation can be either synchronized to the cardiac electrical activity or non synchronized. Pacing protocols with automatic increment and decrement functions provides refractory period measurements.

A variety of stimulation sequences can be created and stored for future use.

The EMS-XL can be used for all types of electrophysiological procedures, including His bundle recording, Sinus Node Recovery Time - SNRT, Overdrive, Wenckebach, and tachy-arrhythmias. An interface to ablation generators provide Ablation Start and End information with data on the ablation parameters.

Each waveform is color-coded for easy identification.

The review monitor allows the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

Special display options support the signal analysis

This includes Trigger mode and template comparison. Event marking. Holter mode: quick. minute-by-minute scrolls and jumps to event, On screen calipers: both real-time and review screen with auto measurement , Auto Tachycardia detection. Free text labeling, and Customized reports in Word™.

The input to the amplifiers is via a patient connection box, to which the intra-cardiac catheter electrodes (not manufactured and not supplied by Mennen Medical) are connected.

This 510(k) summary for the Mennen Medical EMS-XL Cardiac Electrophysiology System focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials. The provided document is a predicate device comparison, which is a common approach for 510(k) submissions.

Therefore, the acceptance criteria and study detailed below are interpreted from the provided predicate comparison tables and the accompanying "Rational for claims of equivalence".

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the specifications of the predicate devices. The reported device performance (EMS-XL) is presented in direct comparison to these predicate specifications. The table below synthesizes information from the various comparison tables provided in the document (Amplifier Spec comparison, Stimulator Spec Comparison, Comparison of Systems).

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

This document describes a predicate comparison for a 510(k) submission, not a direct clinical study with a specified "test set" as one might find for an AI/ML device.

• Sample Size: Not applicable in the context of a prospective or retrospective clinical study of user data. The "sample" here refers implicitly to the specifications and functionalities of the two predicate devices being compared.
• Data Provenance: The data provenance is the technical specifications and reported features of the two predicate devices:
  • K993414 Cardiolab EP system (Prucka Engineering, Inc)
  • K011826 Micropace model EPS 320 (Micropace Pty Ltd.)
    The submission itself is from Mennen Medical Ltd., Israel. The clinical experience mentioned for EMS-XL notes use by clinics "out of the USA" since December 2003, implying international (likely European) usage.

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

Not applicable in this type of submission. The "ground truth" for this submission is the established and legally marketed performance and specifications of the predicate devices. The review and interpretation of these specifications for equivalence determination would be performed by the manufacturer's regulatory affairs team and then by FDA reviewers.

4. Adjudication Method for the Test Set

Not applicable. This is a technical specification comparison, not a clinical trial requiring adjudication of patient outcomes or expert reads. The "adjudication" is essentially the manufacturer's justification (Rational for claims of equivalence) and the FDA's acceptance of those justifications for "substantial equivalence."

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, an MRMC study was not done. This device is a cardiac electrophysiology system, which includes signal acquisition, display, recording, and stimulation capabilities. It is not an AI/ML diagnostic interpretation tool that would typically undergo an MRMC study to assess reader performance with and without AI assistance. The submission confirms that the EMS-XL system is a software-driven, multichannel amplifier and stimulator connected to a computer, focused on acquiring and analyzing physiological signals.

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

Yes, implicitly. The comparison tables are a standalone comparison of the technical specifications and functions of the EMS-XL device against the technical specifications and functions of its predicate devices. The "performance" being evaluated is the device's inherent functional capabilities as designed and manufactured, not an AI algorithm's interpretive ability.

7. The Type of Ground Truth Used

The "ground truth" used is the published and legally established technical specifications and performance characteristics of the predicate devices (Cardiolab EP system and Micropace model EPS 320) as detailed in their 510(k) clearances and product documentation. This is a regulatory "truth" rather than a clinical "truth" (like pathology or outcomes data).

8. The Sample Size for the Training Set

Not applicable. This document does not describe the development of an AI/ML algorithm that would require a "training set." The EMS-XL is a hardware and software system for electrophysiological studies.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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