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The T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring:

• . Pulse rate (via oximetry data)
• . Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP)
• . Temperature
• . Blood Oxygen Saturation (SpO2 via finger oximeter)
  This device is intended for use by qualified healthcare personnel trained in its use.

The Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100 and is intended to monitor a single patient's vital signs. The device is capable of monitoring:

• . Pulse rate (via oximetry data):
• Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP); .
• . Temperature; and
• . Blood Oxygen Saturation (SpO2 via finger oximeter)

The provided document is a 510(k) premarket notification for the Omron HBP T-105 Series Vital Signs monitor. This type of submission relies on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than presenting a full de novo study with detailed acceptance criteria and performance data as might be found in a clinical trial report for a novel AI device.

Therefore, the requested information, particularly regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (especially for AI systems), is largely not present in this document. The document focuses on demonstrating that the new device's specifications are similar to or the same as those of the predicate devices.

However, I can extract what is available and highlight what is missing based on your request.

Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" here are implicitly the specifications of the predicate devices, as the new device claims "same as predicate device" for most performance metrics. The "Reported Device Performance" is also stated in relation to these predicate device specifications.

Missing Information from the Document:

1. Sample sizes used for the test set and the data provenance: This information is not provided. A 510(k) submission for a vital signs monitor often relies on performance data collected during design verification and validation, but detailed sample sizes and population demographics are not routinely included in the public summary. Given the device is a technical modification of existing technology, the "testing" would likely involve demonstrating compliance with recognized standards (e.g., ISO 81060-1 for NIBP, ISO 80601-2-61 for Pulse Oximetry) rather than a novel clinical study for equivalence, and the results are summarized as "same as predicate."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. For device performance, the "ground truth" would be established by reference measurement devices or established clinical protocols, not by expert consensus on, for example, image interpretation.

3. Adjudication method for the test set: Not applicable/not provided. Adjudication is typically relevant for subjective assessments, which is not the primary mode of evaluation for a vital signs monitor.

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: Not applicable. This device is a vital signs monitor, not an AI-powered diagnostic imaging system. There are no "human readers" or "AI assistance" in the context of interpretation of complex medical cases.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of AI. The device's algorithms (e.g., for oscillometric NIBP, SpO2) operate intrinsically. Performance is assessed against reference standards.

6. The type of ground truth used: For vital signs monitors, the ground truth is typically established using independent, highly accurate reference measurement equipment/methods. For example, for NIBP, this might involve simultaneous intra-arterial pressure measurements, or non-invasive methods validated against such standards. For SpO2, it might involve co-oximetry measurements from arterial blood samples. This document does not detail the specific ground truth methods employed in its validation studies, but it is implied that standard validation procedures were followed for each parameter.

7. The sample size for the training set: Not applicable. This device does not employ machine learning/AI in a way that requires a distinct "training set" in the context of general-purpose vital signs monitoring. Its algorithms are based on established physiological principles.

8. How the ground truth for the training set was established: Not applicable, as no AI training set is described.

Summary of Study that Proves the Device Meets Acceptance Criteria

The document states that the Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100. The primary method for proving the device meets acceptance criteria in a 510(k) submission like this is demonstrating substantial equivalence to a previously cleared predicate device.

The "study" in this context is not a standalone clinical trial in the sense of a drug or novel AI device, but rather a series of verification and validation (V&V) tests to confirm that the modified device performs according to its specifications and is at least as safe and effective as the predicate.

The provided table itself serves as the core of this proof, by showing that:

• Many key specifications (measurement method, patient target, accuracy of pressure indicator, accuracy of pulse rate for NIBP, SpO2 measurement method and accuracy for Nellcor, temperature measurement method and accuracy) are "same as predicate device."
• Where changes exist (e.g., power source, display, operating/storage conditions, dimensions, weight, BP module, SpO2 module, addition of Masimo sensors, use of an Omron algorithm for quick BP measurement), these changes are either presented as minor design updates (e.g., battery type, display technology) or by referencing other legally marketed predicate devices for the specific component/feature (e.g., Omron HEM907 for Air Control Valve/Applicable Cuff, Omron HEM-757 for Quick BP algorithm, Nellcor N-595 and Masimo RAD-5 with their respective sensors for SpO2).

The conclusion of the FDA (as shown in pages 4-6) is that the device is "substantially equivalent" to the predicate devices, which signifies that the manufacturer successfully demonstrated that the changes do not raise new questions of safety or effectiveness and that the performance meets acceptable standards, usually through bench testing, engineering analysis, and potentially limited clinical testing if deemed necessary for specific changes (though not detailed here).

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