(119 days)
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:
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (VitaLogik) |
|---|---|---|
| ECG | Substantially equivalent to Envoy | Same as Envoy for: Input Circuit, Chassis Leakage Current, Degree of protection, Electrosurgical Interference Suppression, 3/5/6/12 Lead options, Input Impedance, Input Dynamic Range, Input offset, Noise, Defibrillator Protection, Gain, ECG Analog Output, Sampling Rate and Resolution, Frequency Response, QRS Detection Range, Heart Rate Counting Range/Accuracy, Heart Rate Alarm Settings, Leads analyzed, Common Mode Rejection, Lead Fault Detection, Pacemaker Detection and Rejection, Data Storage. |
| Respiration | Substantially equivalent to Envoy | Same as Envoy for: Lead Selection, Sensitivity Range, Impedance Range, Respiration Rate Counting Range, Respiration Frequency Response, Sampling rate, Respiration Alarm Settings, Data Storage. |
| Blood Pressure (IBP) | Substantially equivalent to Envoy | Same as Envoy for: LED for function, Transducer Excitation Voltage, Site Labels, Input Sensitivity, Dynamic Range, Zero Accuracy, Zero Drift, Blood Pressure Accuracy, Blood Pressure Linearity, Waveform Frequency Response, Sampling Rate, Fault Detection, Data Storage. |
| Cardiac Output & Temperature | Substantially equivalent to Envoy | Same as Envoy for: Adapter and Compatibility Cables, Temperature Range, Accuracy, Excitation, Frequency Response, Cardiac Output Determination Range, Injectate Volumes, Computation Constants, Displayed Data, Data Storage. |
| Non-Invasive Blood Pressure (NIBP) | Substantially equivalent to Envoy | Same as Envoy for: LED for function, Oscillometric Method, Displayed Parameters, Inflation Rate, Initial Inflation, Cycle Times, Measurement Ranges (Adult/Neonatal), Modes, Pressure Accuracy, Heart Rate, Data Storage. |
| Pulse Oximetry (SpO2) | Substantially equivalent to Envoy | Same as Envoy for: Masimo or Nelcor Technology, Saturation Range, SpO2 Accuracy, Pulse Rate Range, Saturation alarm limits. |
| End Tidal CO2 (EtCO2) | Substantially equivalent to Envoy | Same as Envoy for: LED for function, Microstream, Displayed Data, CO2 Display Range, Typical Accuracy (CO2), Typical Accuracy (Respiration Rate), Rise Time, Delay Time, CO2 Alarm Limits, Accuracy (for %/mmHg), Respiration Rate Alarm Limits, Sidestream Flow Rate, Start-up Time, Automatic Compensation, Ambient Temperature, Humidity, Barometric Pressure, Data Storage. |
| Universal Input | Substantially equivalent to Envoy | Same as Envoy for: Interface, Cable In/Out Detection, Electrical Isolation, Displays clinical and technical alarms. |
| Clinical Software Features | Substantially equivalent to Envoy | Same as Envoy for: Waveform Display, Numeric Display, Default Alarms, Data Display, User defined Configuration Setup, User defined Default Settings. |
| Electrical Specifications | Substantially equivalent to Envoy | Same as Envoy for: Main Processing Unit (AC Power Input, Maximum current, Dual fuse), AC Power Output for Local Display, Display Monitor. |
| Environmental Spec. | Substantially equivalent to Envoy | Same as Envoy for: Operating Conditions (Temperature, Humidity, Altitude, Vibration/Shock), Storage Conditions (Temperature, Humidity, Altitude). |
| Displayed Waveforms/Numeric Parameters | Substantially equivalent to Envoy | Many "Same" entries, e.g., ECG (Up to 12 lead), Respiration (1), SpO2 (1), EtCO2 (1). BP (VitaLogik has 2 separate or superimposed vs Envoy's up to 4). Numeric parameters like Heart Rate, Respiration Rate, SpO2, BP, Temperature. EtCO2 (optional for VitaLogik vs optional module for Envoy) |
| Alarm Indications | Substantially equivalent to Envoy | Same as Envoy |
| Display Functions | Substantially equivalent to Envoy | Same as Envoy for: Change ECG Lead Selection, Display of Arrhythmia Information, Data Review (Trends - Graphic/Chart - Tabular), User defined Configuration Setup, User defined Default Settings. |
| Accessories | Substantially equivalent to Envoy | Same as Envoy accessories |
| GUI | Substantially equivalent to Envoy | Same as Envoy (Menu driven) |
| Front End electronics | Integrated front end electronics (vs Module rack for Envoy) | Integrated front end electronics |
| Front Panel keys | Reduced from 10 (Envoy) to 3 (VitaLogik) | 3 (Quicknobe, Main screen, Escape, Event, Silence, Alarm Off - all "Same" too, implying those keys are present on VitaLogik, total 6, but some like Vital Signs, Patient Data, Setup, Timer, Print, Record, Freeze are gone). The document clarifies that functions of omitted keys are accessed via menus or software Quickeys. |
| Main Menu items | Similar functionality to Envoy, with fixed vital signs list | Fixed list of vital signs (vs dynamic for Envoy), but individual parameters (ECG, Respiration, NIBP, Temperature, SpO2, BP, CO, EtCO2) are listed as "Yes" and "Same" respectively. Spirometry and EEG present on Envoy but "No" on VitaLogik. |
| Software Components | Substantially equivalent to Envoy | Same as Envoy for: Display, Operating System (QNX4), GUI, Menus. VitaLogik has a fixed vital signs list (vs dependent on available modules for 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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.