(172 days)
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:
- . ECG waveform derived from 3, 5, 6 and 12 Lead measurements
- . Heart Rate
- . Pulse Oximetry (SpO2)
- ST Segment Analysis ●
- . Arrhythmia Detection
- . Non Invasive Blood Pressure (NIBP)
- Invasive Blood Pressure (IBP) .
- Cardiac Output (CO) .
- . Respiratory Gasses
- . Respiration Rate
- . Temperature
The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
The V Series Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows the user to customize monitored parameters based on a patient's need or acuity level.
The Mindray V Series Monitoring System is a multi-physiological parameter patient monitor. The summary provided does not include specific acceptance criteria values or detailed study results for each parameter. Instead, it states that the device has been tested and found to be in compliance with recognized performance, safety, and electromagnetic compatibility standards.
However, based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not list specific numerical acceptance criteria (e.g., accuracy ranges for SpO2, NIBP, etc.) or quantitative performance results for each physiological parameter. Instead, it states that the device was found "to be in compliance with the following recognized performance, safety and electromagnetic compatibility standards." The listed standards implicitly define the acceptance criteria for each measurement type. For instance, ISO 9919:2005 for pulse oximetry, ANSPAAMI SP10:2002 + A1:2003 + A2:2006 for sphygmomanometers, and EC57:1998/(R)2003 for cardiac rhythm and ST-segment measurement algorithms would each contain detailed performance requirements.
Since specific performance values are not given, a table like the one requested cannot be fully constructed directly from the provided text. The "reported device performance" is implicitly that the device meets the requirements of the cited standards.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was required to confirm the safety and performance of the new features and non significant modification subject to this 510(k) submission." This implies that performance was likely evaluated through engineering bench testing and adherence to recognized standards, rather than through extensive clinical trials with a specific "test set" of patient data. Therefore, details about sample size for a test set and data provenance (country of origin, retrospective/prospective) are not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Given that no clinical testing was required, there is no mention of experts being used to establish a ground truth for a test set. The validation relies on compliance with established technical standards.
4. Adjudication Method for the Test Set
As no clinical testing with a specific test set was conducted that would require ground truth establishment by experts, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was reported. This device is a physiological monitoring system, not typically an imaging interpretation device where MRMC studies are common for evaluating AI assistance.
6. Standalone Performance Study
The summary focuses on compliance with recognized performance, safety, and electromagnetic compatibility standards (e.g., IEC 60601 series, ISO 9919). This indicates that the device's performance was evaluated independently against these standards without human intervention in the loop for the core measurements. Therefore, a standalone performance study was implicitly done by demonstrating compliance with these technical standards, which outline specific test methods and performance requirements for the algorithm and hardware.
7. Type of Ground Truth Used
The ground truth used for performance validation is the reference methods and specifications defined within the recognized performance standards (e.g., calibrated instruments for NIBP accuracy, known signal generators for ECG parameters, etc.). It's not based on expert consensus, pathology, or outcomes data from a clinical trial in this context.
8. Sample Size for the Training Set
This device is a hardware-based physiological monitoring system. The concept of a "training set" is primarily relevant to machine learning or AI algorithms that "learn" from data. While the device may employ algorithms for signal processing (e.g., arrhythmia detection, ST-segment analysis), the 510(k) summary does not indicate that these algorithms were developed using a specific machine learning "training set" in the modern AI sense. Therefore, no information on training set sample size is provided.
9. How Ground Truth for the Training Set Was Established
As no "training set" in the machine learning context is mentioned or implied, the method for establishing its ground truth is not applicable and not provided. Algorithm development for such devices typically relies on established signal processing techniques validated against known physiological models or benchmark databases, rather than a "training set" with expert-labeled ground truth as seen in diagnostic AI.
§ 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.