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The Capsule 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 Capsule Vitals Plus Patient Monitoring System which is the subject of this submission 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.

It operates with the Capsule Medical Device Information Platform (CMDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.

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

• -Capsule Neuron Mobile Platforms
• Capsule Vitals Plus Application |
• Capsule Vitals Plus NIBP Monitoring Modules -
• Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 —
• Capsule Capnography Interface Module -
• Nellcor SpO2 Oximetry Module -
• Masimo uSpO2 Pulse Oximetry Cable
• -Exergen TAT-5000S Temperature Scanner
• -Capsule Early Warning Scoring System

The provided text is a 510(k) summary for the Capsule Vitals Plus Patient Monitoring System. It describes the device, its intended use, comparison to a predicate device, and performance testing. However, it explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving the device meets those criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details.

The summary focuses on demonstrating substantial equivalence by showing that the proposed device has the same intended use and similar technical characteristics as the predicate device (SmartLinx Vitals Plus Patient Monitoring System, K200856), with minor differences that do not raise new questions of safety or effectiveness. The performance testing mentioned refers to hardware and software verification and validation, as well as conformance with FDA recognized consensus standards (listed in Table 4).

Based on the provided text, it is not possible to answer the detailed questions about acceptance criteria and a study proving the device meets them because such a study involving clinical performance with specific metrics (like sensitivity, specificity, or human reader improvement) was not part of this 510(k) submission.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on showing equivalence to a predicate device and conformance to standards, not on demonstrating performance against specific clinical metrics.
2. Sample sized used for the test set and the data provenance: Not present. The performance testing described is primarily engineering verification and validation and compliance with standards, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present. No clinical ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not present.
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 done. This device is a patient monitoring system, not an AI diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a monitoring system intended for use by clinical physicians or appropriate medical staff.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not present.
8. The sample size for the training set: Not applicable/Not present. The document describes a medical device, not a machine learning model that would typically have a training set.
9. How the ground truth for the training set was established: Not applicable/Not present.

Conclusion stated in the document: "The subject of this premarket submission, Capsule Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence." (Page 15)

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