(98 days)
The VSM 6000 Series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure.
- pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
The optional Masimo Rainbow SET® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.
This product is available for sale only upon the order of a physician or licensed health care professional.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is designed to provide a scalable, modular system of components that can be configured to address the needs for vital signs spot check and continuous monitoring.
The CVSM 6000 Series is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), Total Hemoglobin (SpHb and SpHbv), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. The CVSM can also display and transfer patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode, IR temperature, and other patient or facility information. Data can be transferred electronically via USB, wired Ethernet, or wireless communications.
The monitor has an enclosure constructed of engineering plastics with internal steel members for strengthening. A silicone light bar is prominent in a carry handle on the top of the device and illuminates for different alarm conditions. A power button is located on the side of the device. A touch screen display is prominent on the front of the device and provides the primary interface for the user to interact with the device. Internal and external communications are primarily by USB. External host USB connections for accessories are tool accessible. A USB connection for data transfer is on the side of the device, as is a connection to an internal relay for use with nurse call systems. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.
The monitor can be configured for use in different workflows including desktop, affixed to a mobile stand, or on a wall mount.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is a physiological monitor. The provided text indicates that no clinical studies were performed, but rather verification and validation were conducted to ensure expected performance based on relevant international standards. Therefore, some of the requested information regarding clinical studies and ground truth cannot be extracted.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Compliance with various international standards for medical electrical equipment | Verified and validated to ensure expected performance |
| IEC 60601-1:Ed. 2: 1988 | Basic safety and essential performance | Complies |
| IEC 60601-1-2: Ed. 3: 2007 | Electromagnetic compatibility | Complies |
| IEC 60601-1-4: Consolidated Ed. 1.1: 2000 | Programmable Electrical Medical Systems | Complies |
| IEC 60601-1-8: Ed. 1: 2003 | Alarm Systems | Complies |
| IEC 60601-2-30: Ed. 2: 1999 | Manual, electronic or automated sphygmomanometers | Complies |
| ISO 9919: Ed. 2: 2005 | Pulse oximeter equipment | Complies |
| ISO 14971: Ed. 2: 2007 | Application of risk management to medical devices | Complies |
| Functionality | Acquisition and/or display of total hemoglobin utilizing Masimo Rainbow SET® module | Verified and validated |
| Transfer and display of weight, height, and BMI from OEM devices (e.g., Health o meter®) | Verified and validated |
2. Sample size used for the test set and the data provenance
The document explicitly states that "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." Therefore, there is no information on a 'test set' in the context of clinical data, its sample size, or data provenance. The testing appears to have been focused on engineering verification and validation against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical studies with human expert ground truth were conducted.
4. Adjudication method for the test set
Not applicable, as no clinical studies with human expert adjudication were conducted.
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. The device is a vital signs monitor and does not involve AI or human readers interpreting data in a comparative effectiveness study as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire submission focuses on the standalone performance of the device itself (the "algorithm only" in the sense of the device's inherent functionality). The device's performance was evaluated by confirming its compliance with various international standards through "Verification and validation," rather than through a clinical study where its output would be compared to a human interpretation.
7. The type of ground truth used
The "ground truth" used for this device's evaluation was primarily based on compliance with established international engineering and medical device standards. For example, the device was tested to ensure it met the requirements for basic safety, essential performance, electromagnetic compatibility, alarm systems, sphygmomanometers, and pulse oximeters as defined by the listed IEC and ISO standards.
8. The sample size for the training set
Not applicable, as the document does not describe an AI/ML model that would require a training set. The device is a physiological monitor whose performance was validated against established engineering and medical device standards.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/ML model.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).