Search Results

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. SmartLinx Vitals Plus consists of the following components: SmartLinx Vitals Plus Application, SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and SmartLinx Early Warning Scoring System.

The provided text does not contain enough information about acceptance criteria or a study proving that the device meets specific performance metrics. It primarily focuses on the device's substantial equivalence to predicate devices and adherence to recognized safety and performance standards.

The document discusses:

• Device Description: What the device is and its components.
• New Functionality: The additions to the SmartLinx Vitals Plus Application, such as Intervals Mode for NIBP, physiological alarms, continuous SpO2 monitoring features, and integration of the Covidien FILAC 3000 Thermometer.
• Comparison to Predicate Devices: Tables detailing technical characteristics and their differences, and a discussion of why these differences do not raise new questions of safety or effectiveness.
• Safety and Performance Testing: A list of FDA recognized standards that the device complies with (e.g., for general safety, EMC, usability, alarms, software, NIBP, temperature, SpO2, battery, patient monitoring).
• Clinical Studies: A clear statement that clinical studies were not required to support substantial equivalence.

Therefore, I cannot extract the specifically requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided text.

The document states:

• "Extensive performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
• "The subject of this premarket submission, the SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."

This indicates that while performance testing was done against specifications, the specific details of those tests, the acceptance criteria used, and the quantitative results are not included in this summary document.

Ask a specific question about this device

The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System consists of the SmartLinx Vitals Plus mobile medical application and externally integrated vital signs modules operating on the SmartLinx Neuron 2 mobile platform. The application controls the modules at the point of care through interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the monitoring purposes. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, mean arterial pressure (MAP)), pulse rate, functional arterial oxygen saturation (SpO2), and temperature.

The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products:

• The SmartLinx Vitals Plus mobile medical application
• The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses
• The Masimo SET uSpO2 Pulse Oximetry Cable
• The Exergen TAT-5000S infrared thermometer
• The SmartLinx Neuron 2 Mobile Platform
• The SmartLinx Vitals Plus Roll Stand

The provided document details the 510(k) premarket notification for the SmartLinx Vitals Plus Patient Monitoring System. It describes the device, its intended use, and a comparison to a predicate device, focusing on functional equivalence. However, the document does not contain detailed acceptance criteria for specific performance metrics (like accuracy or precision for NIBP, SpO2, or temperature) nor does it provide a study report proving the device meets said criteria with specific quantitative results.

Instead, the document generally states that the device "complies with its predetermined specification" based on various types of testing, often referencing compliance with established electrical safety, EMC, and software standards, as well as a clinical performance standard for NIBP (ISO 81060-2:2013).

Therefore, I cannot populate the table or answer all the requested questions with specific data from the provided text. I will indicate where information is not available.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in the document. For clinical performance testing (referencing ISO 81060-2:2013), this standard typically requires a certain number of subjects (e.g., 85 subjects for NIBP accuracy) and measurements, but the document does not report the actual sample size used for this specific device's clinical performance trial.
   • Data Provenance: Not specified. The document does not indicate the country of origin, nor whether the data was retrospective or prospective.

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

   • Not specified. The document indicates clinical performance testing was done "in accordance with ISO 81060-2:2013". For NIBP validation studies, ground truth (reference measurements) are typically established by trained technicians using a reference device (e.g., auscultation with mercury sphygmomanometer), but the number and qualifications of these individuals are not detailed in this submission.

3. Adjudication method for the test set:

   • Not specified. If ground truth involved multiple measurements or experts, an adjudication method would typically be used, but this information is absent.

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. This device is a vital signs monitor, not an AI-assisted diagnostic imaging device that involves "human readers" or "AI assistance" in that context. Therefore, an MRMC study and AI improvement effect size is not applicable to this type of device and was not conducted.

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

   • Yes, to an extent. The performance testing described (Software Testing, Electrical Safety, EMC Testing, Bench Performance Testing, and Clinical Performance Testing conforming to standards like ISO 81060-2:2013) essentially evaluates the device's inherent performance. While the device is intended for use by healthcare providers, these tests assess the accuracy and reliability of the device's measurements and functions independent of a human's interpretation of those measurements in a diagnostic workflow (which is the typical context for "standalone AI performance"). The software and hardware perform their functions (measuring NIBP, SpO2, temp) without direct "human-in-the-loop" assistance for the measurement process itself.

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

   • For NIBP, the ground truth would typically be established by simultaneous auscultatory measurements by trained observers using a reference device, as per the methodology specified in ISO 81060-2.
   • For SpO2, ground truth is usually established by CO-oximetry of arterial blood samples.
   • For temperature, ground truth would be from a precisely calibrated reference thermometer or other established method.
   • The document does not explicitly state the ground truth methodology beyond referencing the ISO standards, but these standards define the accepted methods for ground truth establishment.

7. The sample size for the training set:

   • Not applicable. This document describes a traditional medical device (a vital signs monitor) and its validation. It does not refer to an AI/Machine Learning model that requires a "training set" in the conventional sense. The software development process mentioned is likely for deterministic software, not a learned model.

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

   • Not applicable, as there is no "training set" for an AI/ML model described in this document.

Ask a specific question about this device