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510(k) Data Aggregation
(221 days)
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.
| Parameter | Acceptance Criteria (VitaLogik 6000/6500 Performance) | Reported Device Performance (Menntor X7) |
|---|---|---|
| Hardware Parameters | ||
| Input Circuit Parameters | Configured | 2 Plug-in modules, Plug-in Multi Parameter Module (MPM) |
| Chassis Leakage Current | All patient signal inputs fully isolated (<50 μA); Meets or exceeds ANSI standard: "Safe Current Limits for Electromedical Apparatus," (SCLE) Dec, 1978 item 2.1.1. | Same |
| Front End electronics | Integrated front end electronics | Plug-in MPM |
| Front Panel keys | 5 | Same |
| Quicknobe | Yes | Same |
| Main screen | Yes | Same |
| Escape | Yes | Same |
| Silence - Red | Yes | Same |
| Alarm Off - Red | No | Yes |
| Print - Green | Yes | Same |
| NIBP Start/Stop - Yellow | Yes | Same |
| Software/Display Functions | ||
| Main Menu, Vital Signs, Patient data, Setup, Utilities, System Setup | Fixed list, List of patient data, Setup menu, List of virtual keys, Password protected | Same |
| Display size | 15 inch | Same |
| Display | All waveforms and numeric vital sings | Same |
| Operating System | QNX4 | Same |
| GUI, Menus | Same, Full set | Same |
| LAN | Yes, Optional Wireless LAN | Same |
| Optional Hardware enable | Touch screen | Same |
| Change ECG Lead Selection | YES | Same |
| Display of Arrhythmia Information | YES | Same |
| Data Review: Trends - Graphic | YES | Same |
| Data Review: Chart - Tabular | YES | Same |
| User defined Configuration Setup/Default Settings | YES | Same |
| Accessories | Accessories | Same |
| Vital Signs Inputs | ||
| ECG (Leads, Freq Response, Input Impedance, CMR, Input Dynamic Range, Input offset, Gain, Noise, Pacemaker Pulse Rejection, Defibrillator Protection, Lead Fault Sense, QRS Detection, Synchronous Defibrillation Signal, Analog Output) | 3, 5 or 12 leads; 0.5 to 40 Hz (Monitor), 0.05 to 150 Hz (Diagnostic), 1 to 25 Hz (Exercise); Typical 20 MΩ; At least 100 dB; ±5mV p-p; ±300mV; Manual selection of 250-8000x; Less than 30 μV p-p; 2.0 mV to 700 mV pulses of 0.2 to 2.0 mSec; Up to 5 KV, < 3 sec recovery; On any ECG electrode; 0.25 to 5.0 mV, 70-120 msec width; Pulse Width: 100 ms, Amplitude: 5 Vdc; 1 Volt / mVolt | Same |
| Heart Rate (Range, Acc, Response Time) | 20 to 350 bpm; Within 2 bpm; Less than 7 sec | Same |
| Blood Pressure (Input Sensitivity, Transducer Excitation, Ranges, Max variation, Zero Accuracy, Zero Drift, Transducer Load Impedance, Linearity, CMR, Freq Response) | 5 μvolts/volt/mmHg; 5 Volt; -50 to +300 mmHg; ± 2 mmHg; ± 0.2 mmHg; Less than ± 0.2 mmHg in 24 hours; 300 – 600Ω; Better than 1%; 80 dB minimum; DC to 12 Hz (DC to 40 Hz optional) | Same |
| Cardiac Output | Yes | Yes |
| Temperature (Range, Accuracy) | 27 °C to 45°C; ± 0.2°C | Same |
| Respiration (Freq Response, Range, Excitation) | 0.13 to 2.5 Hz, 3 dB bandwidth; 8 to 150 bpm; 65 kHz | Same |
| Pulse Oximetry (SpO2) (Probe Type, Range, Pulse Rate Range, Rate Accuracy, SpO2 Accuracy) | Masimo™ or Nellcor; 0% to 100%; 20-250 bpm; ± 3 bpm; Determined by specific sensor: ±2 digits (70-100%), ±3 digits (50-70%), ±3 digits (70-95%) | Same |
| Non-Invasive Blood Pressure (Method, Initial Inflation, Pressure Accuracy) | Oscillometric; 150 mmHg (adult), 120 mmHg (pediatric); Overall ± 3 mmHg | Same |
| EEG (Features, Number of channels) | EEG + aEEG; 2 | Same |
| Protection | ||
| Defibrillator Pulse Protection | 5KV as per ANSI/AAMI EC13 (9), clause 3.2.2.2 and per IEC 60601-2-27 (12), clauses 17,101 and 102 | Same |
| Degree of protection against electrical shock | Type CF and BF (ECG, IBP, CO = CF; NIBP, SpO2 = BF) | Same |
| Electrosurgical Interference Suppression | Yes | Same |
| Displayed Waveforms | ||
| ECG, BP, Respiration, SpO2, EtCO2, EEG | Up to 12 lead; Up to 4, separate or superimposed; 1; 1; 1; 2 channels | Same |
| Displayed Numeric Parameters | ||
| Heart Rate, Respiration Rate, SpO2, BP (Systolic/Diastolic/Mean), Temperature, EtCO2, CerebraLogik interface, Alarm Indications | Yes; Yes; Yes; Yes; 2; Yes (optional); EEG & aEEG; Yes | Same, Plug-in Module (option for EtCO2) |
| Spirometry Module (compared to Envoy) | ||
| Module size | Height: 10.0cm, Width: 4.0 cm, Depth: 14.0 cm | Height: 9.5cm, Width: 4.0 cm, Depth: 11.5 cm |
| Display Function (Air Flow, Volume, Airway pressure, Flow-volume loop, Pressure-volume loop, Pressure-flow loop, Derived parameters) | All Yes | Same |
| Pulmonary mechanics parameters | Vt_e. PIP, PEEP, MAP, Plat, PF_i, PF_e, RR, Ve, I:E, COMP, RES, RSBI | Same |
| Clinical Alarms for derived parameters | Visual & Sound Alarms | Same |
| Data Storage (Trend, Chart, Waveforms) | Trend: Yes - up to 3 months; Chart: Yes- up to 3 months; Waveforms: Yes- up to 72 hours | Trend: Yes - up to 80 days; Chart: Yes - up to 80 days; Waveforms: Yes - 5 days |
| Degree of protection against electrical shock | Type BF applied part | Same |
| Sampling | 100 sps | Same |
| Airway Adapter spec (Flow Range, Accuracy, Dead Space, Connections, Length, Weight, Material) | 2 - 180 lpm; ± 5 % reading, or 0.5 lpm; 6.9 ml; 15 mm ID/22 mmOD patient end by 15 mm ID ventilator end (ISO 5356-1), Proprietary Smart connector, Tri-Tubing - triple 0.055" inch ID lumen; 2.5 inches (adapter) - 6 feet (tubing); 6.3 grams (minus tubing); Sensor - Polycarbonate (Makrolon), Tubing - Medical grade Polyvinyl Chloride | Same |
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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