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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

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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 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.

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

The VitaLogik 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 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 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 VitaLogik is a configured multi-parameter physiological patient monitor, based on the hardware and software of the Mennen Medical Envoy monitor, without the module rack and modules.

The front end electronic is composing the modules hardware and software into the chassis of the Bed Side Computer =BSC. The input connectors are incorporated in the front panel of the BSC

It is offered in two basic options: Non-Invasive monitor and Full monitor.

In the Non-Invasive version the vital signs are ECG, NIBP, SpO2 and Temperature. The Full monitor includes also two invasive Blood Pressures and Cardiac Output. Both have EtCO2 as an option.

The provided document is a 510(k) premarket notification for a device modification, specifically the "VitaLogik" patient monitor, which is a modified version of the "Envoy" patient monitor. The document primarily focuses on demonstrating substantial equivalence to the predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for the VitaLogik device itself.

Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state acceptance criteria in a quantitative format. Instead, it demonstrates that the VitaLogik device's performance characteristics are "Same" as the predicate Envoy device across a wide range of parameters. The acceptance criterion inherently is "performance is substantially equivalent to the predicate device."

Here's a table summarizing the reported device performance, noting that for almost all parameters, the VitaLogik is stated to be "Same" as the Envoy:

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

The document does not specify a "test set" in terms of patient data or clinical cases. The testing conducted was focused on proving that the device "meets all functional requirements and performance specifications" and complies with applicable industry and safety standards (IEC 60601 series). This suggests bench testing and possibly internal validation based on engineering specifications, rather than a clinical study with a patient data set.

Therefore, there is no stated sample size for a test set and no information on data provenance (country of origin, retrospective/prospective clinical data).

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)

Since there is no mention of a clinical test set requiring expert interpretation or ground truth establishment from medical professionals, this information is not applicable and not provided in the document. The "ground truth" for the engineering and safety testing would be the established performance specifications and voluntary standards (e.g., IEC standards).

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

As no clinical test set requiring human interpretation is described, adjudication methods are not applicable and 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

The VitaLogik is a physiological patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described.

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

The document describes "extensive safety and performance testing" of the VitaLogik device, indicating it was tested as a standalone system to ensure it met functional requirements and specifications. However, this is not an "algorithm-only" standalone performance in the context of an AI device. It refers to the device's performance as a complete monitoring system without necessarily involving human operators during the performance tests (though human interaction would be part of usability/safety). The performance data presented (e.g., accuracy of HR counting, BP, SpO2, EtCO2, etc.) are inherent to the device's measurement capabilities.

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

The ground truth for the testing appears to be the defined engineering performance specifications and the requirements of voluntary international standards (IEC 60601 series) mentioned in the document. These standards set benchmarks for safety, electrical characteristics, and performance accuracy for various physiological measurements. For example, for Heart Rate Accuracy, the ground truth would be a validated reference measurement against which the device's stated accuracy of "± 2 BPM" would be verified.

8. The sample size for the training set

The document describes a device modification, not a machine learning or AI algorithm where a "training set" would be typically used. The VitaLogik's software is stated to be "a brunch of the Envoy SW," meaning it's derived from the predicate device's existing software with modifications related to the hardware changes. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

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

As there is no "training set" described for the VitaLogik in this context, this question is not applicable. The device relies on established physiological measurement principles and software developed to implement these principles, inherited from the predicate device.

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