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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), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

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), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates with the SmartLinx Medical Device Information Platform (MDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.

The proposed SmartLinx Vitals Plus Patient Monitoring System consists of the following components:

• SmartLinx Neuron Mobile Platform
• SmartLinx Vitals Plus Application
• SmartLinx Vitals Plus NIBP Monitoring Module
• Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02
• Nellcor SpO2 Oximetry Module
• Masimo uSpO2 Pulse Oximetry Cable
• Exergen TAT-5000S Temperature Scanner
• SmartLinx Early Warning Scoring System

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. Instead, it describes a "SmartLinx Vitals Plus Patient Monitoring System" which is a medical device data system that integrates various vital signs modules.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study for a new, novel device.

The "Performance Testing" section mentions adherence to FDA recognized consensus standards (Table 4), which are often general safety and performance standards for similar types of medical devices (e.g., electrical safety, electromagnetic compatibility, usability, software lifecycle, and particular requirements for specific monitoring components like non-invasive blood pressure, pulse oximetry, and respiratory gas monitors). This is a different type of "acceptance criteria" than what might be established for a novel AI/ML-based diagnostic device.

Crucially, the document explicitly states:

• "The subject of this premarket submission, SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot extract the specific information requested about acceptance criteria and a study proving the device meets them from this document, as there was no such clinical study performed or required for this 510(k) submission.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to conformance with recognized consensus standards (Table 4) rather than specific performance acceptance criteria for a novel functionality.
2. Sample sized used for the test set and the data provenance: Not applicable, as no clinical study was required or performed. Performance testing involved hardware and software verification, validation, and testing against consensus standards, not a "test set" of patient data in the typical sense of an AI/ML study.
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 study was required or performed that involved expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML-based diagnostic or assistive technology that would typically undergo an MRMC study. It is a patient monitoring system integrating existing vital sign modules.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The device relies on the established accuracy and ground truth of its component modules (e.g., NIBP, SpO2, CO2 sensors) which are themselves regulated and have their own performance specifications.
8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

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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 predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K180734. 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. The proposed SmartLinx SmartLinx Vitals Plus Patient Monitoring System is similar to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K180734. The change being proposed is to integrate the SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus Alarm Hub and Nellcor SpO2 Pulse Oximetry Module into one module or backpack configuration; and the alternative Masimo SpO2 pulse oximetry cable will continue to be connected to the same place as with the predicate. There is no change to the performance or functionality of the device. There is no change to the indications for use or intended use.

The provided text describes a 510(k) submission for a patient monitoring system, focusing on a configuration change rather than a new AI algorithm for diagnosis or treatment. Therefore, many of the requested elements for AI-based device studies (like sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies) are not applicable or explicitly mentioned in this document.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" in this submission revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is achieved by showing that the proposed device, despite a configuration change, does not raise new questions of safety and effectiveness and performs equivalently to the predicate.

• Electromagnetic Compatibility, Electrical Safety, and Safety Standards (e.g., ANSI AAMI ES 60601-1, IEC 80601-2-30 for NIBP, IEC 60601-1-2 for EMC, IEC 60601-2-49 for multifunction monitoring, ISO 80601-2-61 for pulse oximetry, IEC 60601-1-8 for alarms)
• Usability (IEC 60601-1-6, IEC 62366-1)
• Software (IEC 62304:2006)
• Batteries (IEC 62133:2012) |
  | Equivalence in Design, Features, and Functionality to Predicate | The study concluded that the proposed system results in an equivalent design, features, and functionality with "few exceptions that do not raise new questions of safety or effectiveness." |

Study Information (based on provided text):

1. Sample size used for the test set and the data provenance: This information is not provided in the document. The testing described is primarily focused on demonstrating physical and functional equivalence of hardware and software components through bench testing and adherence to standards, rather than evaluating performance against a clinical test set in the way an AI algorithm would be. The document does not specify the number of devices or scenarios used in the "performance testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to this submission. The device is a patient monitoring system, not an interpretive AI algorithm that requires expert-established ground truth for performance evaluation in a clinical test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable for the reasons mentioned above.

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: This is not applicable. This submission is for a patient monitoring system with a configuration change, not an AI-assisted diagnostic tool.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is a monitoring system intended for use by clinical physicians or appropriate medical staff, inherently involving human interaction. The submission does not describe a standalone algorithm performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing conducted, the "ground truth" would be established by the specifications and expected outputs of the individual physiological parameter modules (NIBP, SpO2, Temperature) as defined by their respective recognized standards (e.g., accuracy requirements for NIBP monitors per IEC 80601-2-30). The document refers to "bench testing," "testing to FDA recognized consensus standards," and "software verification and validation testing," inferring that these standards define the expected "truth" or acceptable performance ranges.

7. The sample size for the training set: This is not applicable. The device is not an AI/ML model that undergoes a training phase.

8. How the ground truth for the training set was established: This is not applicable for the reasons mentioned above.

Summary of the Study:

The "study" in this context is a comprehensive set of performance testing designed to demonstrate that a design configuration change to an existing, cleared patient monitoring system (SmartLinx Vitals Plus Patient Monitoring System, K180734) does not negatively impact its safety, effectiveness, or functionality.

The study involved:

• Bench Testing: To ensure the modified hardware and integrated components perform as expected.
• Software Verification and Validation Testing: To confirm the software (SmartLinx Vitals Plus Application, SmartLinx EWSS) functions correctly with the new configuration.
• Conformance to FDA Recognized Consensus Standards: This involved extensive testing against standards such as those for electrical safety (ANSI AAMI ES 60601-1), NIBP accuracy (IEC 80601-2-30), SpO2 accuracy (ISO 80601-2-61), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366-1), alarm systems (IEC 60601-1-8), and software lifecycle processes (IEC 62304).

The document explicitly states: "This Special 510(k) for the proposed SmartLinx Vitals Plus Patient Monitoring System did not require clinical studies to support substantial equivalence." This reinforces that the focus was on technical and functional equivalence through non-clinical testing.

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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. It consists of the SmartLinx Vitals Plus Application (a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform), 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 optionally the SmartLinx Early Warning Scoring System (EWSS). The system collects vital signs data from sensors connected to the SmartLinx Neuron 2 Mobile Platform, which serves as the user interface and supports connectivity with the electronic medical record (eMR). The proposed device is identical to the predicate device (K171751) with the addition of the option for Nellcor SpO2 Pulse Oximetry solution and software upgrades.

The provided document is a 510(k) summary for the SmartLinx Vitals Plus Patient Monitoring System. It outlines changes to an already cleared device, primarily the addition of Nellcor SpO2 pulse oximetry solution and software upgrades.

The document explicitly states that "clinical studies to support substantial equivalence" were not required. Therefore, there is no information in this document regarding:

• Acceptance criteria expressed as performance metrics or targets.
• A specific study proving the device met such acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number of experts or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used or how it was established for training or testing sets.

Instead, the submission relies on:

1. Comparison to a legally marketed predicate device (SmartLinx Vitals Plus Patient Monitoring System, K171751) and a reference device (Zoe Medical's 740 Select, K130411). The core argument is that the modifications (primarily the addition of Nellcor SpO2) do not raise new questions of safety and effectiveness, as the reference device already supports Nellcor SpO2.
2. Performance testing: This is described as "hardware and software verification and validation, as well as testing to FDA recognized consensus standards."
3. Conformance with FDA recognized consensus standards: A table of standards (such as ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 62304, etc.) is provided to demonstrate adherence to established safety and performance requirements for medical electrical equipment, including pulse oximeters and software.

Therefore, the tables and information requested cannot be derived from the provided text, as this 510(k) relies on substantial equivalence through design and standards conformance, rather than new clinical performance data for the specific changes.

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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.

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