(343 days)
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
The V10 vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana V10 vital signs monitor is a lightweight and compact device (298 × 218 × 172 (mm) (W×H×D) and 3.4 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment and LED displays.
The Mediana V10 device is a vital signs monitor designed to measure non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), and temperature (Temp) in adult, pediatric, and neonatal patients across various healthcare settings.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria with specific thresholds for each vital sign measurement or detailed performance data for the V10 device itself. Instead, it states that the V10's specifications and performance are equivalent to predicate devices that comply with specific standards.
Therefore, the table below will reflect this equivalence statement. The "Acceptance Criteria" are implied by the standards and performance of the predicate devices, and "Reported Device Performance" is stated as being equivalent.
| Measurement Parameter | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance |
|---|---|---|
| Non-Invasive Blood Pressure (NIBP) | Complies with AAMI SP10 standard (same as Mediana ARGUS VCM) | Equivalent to Mediana ARGUS VCM |
| Pulse Rate (PR) | Equivalent to Mediana ARGUS VCM, Mediana P10, and Covidien Nellcor Bedside SpO2 | Equivalent to Mediana ARGUS VCM, Mediana P10, and Covidien Nellcor Bedside SpO2 |
| Pulse Oximetry (SpO2) | Equivalent to Mediana P10 and Covidien Nellcor Bedside SpO2 | Equivalent to Mediana P10 and Covidien Nellcor Bedside SpO2 |
| Temperature (Temp) | Equivalent to GE CARESCAPE V100 and Tyco Kendall Genius 2 | Equivalent to GE CARESCAPE V100 and Tyco Kendall Genius 2 |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The Mediana vital signs monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 included with the submission using production equivalent units prior to release to market."
- Sample Size for Test Set: Not specified. The document mentions "production equivalent units" but does not provide a number or range for the test set sample size.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set within the provided text. The assessment relies on equivalence to devices that already comply with established standards.
4. Adjudication Method for the Test Set
There is no information provided regarding an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No evidence of a MRMC comparative effectiveness study. The document focuses on the technical equivalence of the V10 to predicate devices, not on the improvement of human readers with or without AI assistance. The V10 is a standalone vital signs monitor, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone performance assessment was conducted, but it's framed as equivalence testing. The document states: "The Mediana vital signs monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 included with the submission using production equivalent units prior to release to market." This indicates that the device itself underwent testing to demonstrate its performance, which was then compared to that of predicate devices to establish substantial equivalence. However, the exact performance metrics or detailed results of this standalone testing are not provided, only the conclusion of equivalence.
7. Type of Ground Truth Used
- The "ground truth" for the V10's performance is implicitly tied to the performance established by the predicate devices and their adherence to recognized standards (e.g., AAMI SP10 for NIBP). For example, if the predicate device's NIBP measurements were validated against an invasive arterial line (a common ground truth for NIBP), then the V10's "equivalence" implies it meets similar accuracy standards. However, the document does not directly state the specific ground truth used for the V10's own testing.
8. Sample Size for the Training Set
- Not applicable / Not specified. The V10 is described as a vital signs monitor, which typically relies on established measurement principles and calibrated sensors, not a machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not relevant to this device as described.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not specified. As the device does not appear to be an AI/ML-based system requiring a training set, this question is not relevant.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).