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The VSM 6000 series of monitors 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), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments. This product is available for sale only upon the order of a physician or licensed health care professional.

The Welch Allyn VSM 6000 series is designed to provide a scalable, modular system that could be configured to address the needs for vitals signs spot check and monitoring, by using interchangeable components. The VSM 6000 series of monitors 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) and body temperature of neonatal, pediatric and adult patients. The overall device 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 LCD with a touch screen 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 is primarily by USB. External host USB connections for accessories are tool accessible. A user accessible client USB connection for data transfer is on the side of the device. A connection to an internal relay for use with nurse call systems is provided on the side of the device. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.

The provided text lacks specific acceptance criteria and detailed study information that would allow for a comprehensive breakdown of the device's performance against such criteria. However, I can extract what is available and highlight what is missing based on your request.

Here's a summary of the available information and an outline of the missing components for a full response:

Device: Welch Allyn VSM 6000 Series Vital Signs Monitor

1. Table of acceptance criteria and the reported device performance:

Study Information:

The critical piece of information for all clinical performance aspects is stated directly:
"No clinical studies were utilized for the purpose of obtaining safety and/or efficacy data."

This means that the device's performance and safety were established based on its substantial equivalence to predicate devices through non-clinical performance data (i.e., adherence to recognized standards) and the incorporation of previously cleared modules and algorithms.

Therefore, many of the requested points below cannot be answered directly from the provided text, as they pertain to clinical studies that were not performed for this 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not Applicable. No clinical test set was used, as no clinical studies were performed. The device's performance relies on the established performance of its predicate components and adherence to standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No clinical test set was used.

4. Adjudication method for the test set:

• Not Applicable. No clinical test set was used.

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 vital signs monitor and does not involve "human readers" or "AI assistance" in the context of diagnostic image interpretation that an MRMC study would typically evaluate.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Partially Applicable. The noninvasive blood pressure (Oscillometric), SpO2, and temperature algorithms operate in a "standalone" fashion within the device to generate measurements. However, the performance assessment was not a new standalone study of these algorithms. Instead, it was based on the fact that these algorithms are "equivalent to the algorithm used in the Welch Allyn NIBP, Spot Ultra Vital Signs and Welch Allyn VSM 53000 (VSM 300 series)" (all previously cleared devices).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable/Indirect. For the purpose of this 510(k), the "ground truth" for the VSM 6000 series' performance is the regulatory acceptance and established performance of its predicate devices and their integrated components, as well as compliance with relevant IEC and ISO standards. No new "ground truth" was established for this specific device through clinical data.

8. The sample size for the training set:

• Not Applicable. Since no new clinical studies were conducted for this device to generate new performance data, there was no "training set" in the context of developing new algorithms or models. The algorithms are inherited from previously cleared devices.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8. The ground truth for the predicate devices' algorithms would have been established during their respective clearances, but this information is not provided here for the VSM 6000.

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