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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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