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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. Monitoring can be accomplished on the VSM 6000 series bedside monitor itself and the VSM 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.g., at a central station). Secondary remote viewing and alarming features are intended to supplement and not replace patient bedside monitoring.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with 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.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

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 Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor 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. Patient monitors equiped with Masimo Rainbow SET® pulse Co-Oximeter modules are also capable of total hemoglobin measurements (SpHb, SpHbv) and acoustic respiration rate (RRa). Patient monitors equiped with Oridion capnography are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI). 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 scanner, IR temperature, and other patient or facility information. Data can be transferred electronically via USB, wired Ethernet, or wireless communications. Ethernet and wireless are intended for communication of vital signs parameters, patient data, and alarms (including continuous and episodic parameters and alarms) to secondary remote viewing and alarming systems. The Welch Allyn Application Framework (Framework) - has been included as a separate subsystem. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of and isolated from the CVSM's vital signs monitoring functionality.

The monitor has an enclosure constructed of engineered 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.

Here's an analysis of the provided text regarding the Welch Allyn Connex® Vital Signs Monitor 6000 Series, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Summary for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results for proving novel acceptance criteria. As such, many of the requested details about specific performance metrics, sample sizes, and ground truth establishment from a clinical effectiveness study are not present in this type of document. The document explicitly states "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." (Section 4).

Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for the device's functions. Instead, it relies on demonstrating compliance with recognized medical device standards and substantial equivalence to predicate devices. The "reported device performance" is thus implied through its compliance with these standards and the assertion of equivalence in technological characteristics and indications for use.

Explanation of "Reported Device Performance": The document indicates that "Verification and validation were conducted to ensure expected performance of the CVSM 6000 Series with enabled Masimo Rainbow SET® and the Oridion capnography module." This implies that the device meets the functional and safety requirements outlined by the referenced standards and the performance of the integrated predicate modules.

Study Details

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

   • Sample Size: Not applicable. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." (Section 4). The verification and validation were non-clinical, likely involving bench testing and engineering validation.
   • Data Provenance: Not applicable for a clinical test set. The validation was based on non-clinical testing against design specifications and international standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as no clinical test set with human-established ground truth was used.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as no clinical test set requiring human adjudication was used.

4. 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:

   • No. An MRMC study was not done. The device is a vital signs monitor, not an AI-assisted diagnostic tool for human interpretation improvement.

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

   • Yes, in a sense. The "performance" was assessed as a standalone device against engineering specifications and relevant standards through non-clinical testing. This isn't an "algorithm only" in the AI sense, but rather the integrated system's performance. The document doesn't detail specific algorithmic performance for features like "Integrated Pulmonary Index" but rather the functional correctness of its calculation.

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

   • The "ground truth" for the non-clinical tests would have been the established gold standards defined by the referenced IEC and ISO standards (e.g., accuracy limits for blood pressure, SpO2, CO2, etc.) and the documented performance of the predicate modules (Masimo, Oridion) that were integrated. For example, a blood pressure measurement device would be tested against a known reference pressure source to verify accuracy within specified tolerances.

7. The sample size for the training set:

   • Not applicable. This device is a vital signs monitor, not an AI/machine learning model that requires a "training set" in the conventional sense. Its functionality is based on established physiological measurement principles and signal processing, not data-driven learning.

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

   • Not applicable for the same reason as above.

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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

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.

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