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The Welch Allyn Vital Signs Monitor is intended for monitoring of blood pressure, pulse rate, temperature and oxygen saturation (SpO2) of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated.

• The Welch Allyn Vital Signs Monitor is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn Small Child cuffs are the smallest cuffs approved for use with young children and infants. The circumference of the child's arm must fit within the range markings on the cuff.
• The Welch Allyn Vital Signs Monitor should not be used on patients who are linked to heart/lung machines.

The Welch Allyn Vital Signs Monitor is designed to non-invasively and automatically measure systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. THE WELCH ALLYN VITAL SIGNS MONITOR IS NOT INTENDED TO BE USED ON NEONATAL PATIENTS. All blood pressure, pulse, temperature and SpO2 values are displayed on large, easy-to-read displays, and may be printed via an integrated thermal printer, as desired. The rechargeable battery and wide variety of mounting accessories make the Welch Allyn Vital Signs Monitor convenient for many locations. The operator may choose any combination of simultaneous measurement modalities. This flexibility, combined with features such as programmable alarms and automatic blood pressure cycles, makes the Welch Allyn Vital Signs Monitor ideal for a wide variety of patient monitoring needs.

The provided document describes the Welch Allyn Vital Signs Monitor, an updated version of a previously cleared device, primarily focusing on the change of the SpO2 module.

Here's an analysis of the acceptance criteria and the study justifying the device's performance, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document mentions "Accuracy test" as a validation test. However, it does not explicitly state specific numerical acceptance criteria (e.g., within X mmHg for blood pressure, within Y% for SpO2) or the quantitative reported device performance against such criteria. The submission states that the device "passed all the safety and effectiveness testing," implying that any implicit acceptance criteria for these tests were met.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample sizes used for the "Accuracy test" or "Usage test" for the Welch Allyn Vital Signs Monitor with the new MP506 module. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of any data collected during these tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

The document does not mention the use of experts to establish ground truth for any of the described tests. The testing described appears to be focused on device functionality, safety, and compliance with manufacturing/module-specific standards rather than a clinical performance study requiring expert adjudication of patient data for ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as there is no indication that expert review of patient data was part of the testing described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device through verification and validation of changes (specifically the SpO2 module).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

The "Accuracy test" and "Nellcor compliance testing" performed on the SpO2 module can be considered standalone performance evaluations of that component. The overall device testing (software functional, basic functional) also assesses the device's inherent performance. There's no mention of a human-in-the-loop performance study in the context of its accuracy, but rather general "usage test" which might involve human interaction.

7. The Type of Ground Truth Used:

For the SpO2 module, the "Nellcor compliance testing" implies that the ground truth would be based on the established gold standards and methodologies used by Nellcor for validating pulse oximetry, which typically involves controlled desaturation studies against arterial blood gas measurements (co-oximetry). However, this is inferred, not explicitly stated regarding the data collected for this submission. For other metrics like blood pressure, temperature, and pulse rate, the ground truth for an "Accuracy test" would typically involve comparison against a reference standard device. The document does not explicitly detail these ground truth methods.

8. The Sample Size for the Training Set:

The document describes verification and validation testing for the updated device, not the development of an algorithm that would require a training set. The device is a measurement instrument, and the core technology for SpO2, blood pressure, etc., relies on established physical principles and algorithms, not a machine learning model that requires a distinct training/test split in the way AI/ML devices do. Therefore, a "training set" is not applicable in the context described.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable.

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