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The HomMed Sentry IIIB-F Patient Monitor System is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry IIIB-F Patient Monitor System is available with physicians' orders only.

The HomMed Sentry IIIB-F Patient Monitor System measures the following parameters: Non-Invasive Blood Pressures (Systolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SpO₂), Peripheral Pulse Rate (PPR), Pulse Strength, Oral Temperature and Patient Weight via an external scale. The HomMed Sentry IIIB-F Patient Monitor System's optional, compatible devices extend those measurements to glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) monitoring and digital image acquisition. The patient parameter data is collected and displayed by the HornMed Sentry IIIB-F Patient Monitor System. Data can be transmitted via the communication module to a central station where the patient data can be viewed and analyzed.

The HomMed Sentry IIIB-F Patient Monitor System (Sentry IIIB-F) is a portable patient vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) measuring, and digital image acquisition capabilities. The Sentry IIIB-F acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.

Sentry IIIB-F provides a noninvasive blood pressure (NIBP) monitor for measurements of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures; pulse oximeter, acquires a pulse rate using an oximeter; oral temperature via an electronic thermometer; weight from an electronic scale. All data collected from these functions as well as optional glucometry, ECG devices, PT/INR monitor and acquired digital images are sent through an internal communication module.

The provided 510(k) summary for the HomMed Sentry IIIB-F Patient Monitor System states that the device's performance has been confirmed to be equivalent to its predicate device (HomMed Sentry III Patient Monitor System with Card Reader, K014025). The summary also mentions compliance with various national and international standards. However, it does not provide a detailed list of specific acceptance criteria or the reported device performance in a numerical or quantitative format. Instead, it offers a general statement regarding compliance and consistency with guidelines.

Therefore, the requested table of acceptance criteria and reported device performance, as well as several other detailed study parameters, cannot be fully extracted from the provided text. The document focuses on regulatory compliance and equivalence to a predicate device rather than presenting a standalone clinical or performance study with detailed statistical results.

Here's a breakdown of what can and cannot be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified. The document mentions "testing done on the Sentry III IIIB-F" but does not provide details on sample size (e.g., number of patients, number of measurements), data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. The nature of the device (vital signs monitor) suggests that ground truth would typically be established by validated reference devices rather than human experts interpreting complex data. The document does not mention any expert involvement in establishing ground truth for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. This type of adjudication is typically used for subjective interpretations by multiple human readers (e.g., in imaging studies). For a vital signs monitor, performance is usually assessed against a known standard or reference device, not via subjective adjudication.

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

• No. This is not an AI-assisted device, nor is it a device that involves human readers interpreting complex cases in the way that an MRMC study would apply. Therefore, no such study was conducted or reported.

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

• Yes, implicitly. The "Performance Data" section describes "testing done on the Sentry III IIIB-F" to assure compliance with standards and to demonstrate it "performed within its specifications and functional requirements." This refers to the device's inherent performance. Since this is a direct vital signs measurement device, its "standalone" performance is its primary mode of operation. There is no "algorithm only" in the sense of an AI model being evaluated separately from the device's physical sensors and processing.

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

• Implicitly, reference standards or validated measurement methods. For vital signs, ground truth would be established by highly accurate, often invasive or gold-standard, reference devices (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2, calibrated scales for weight, etc.). The document does not explicitly state the specific reference devices used but implies comparison to established and validated measurement techniques.

8. The sample size for the training set

• Not applicable/Not specified. This device is not an AI/machine learning device that requires a training set in the conventional sense. Its performance is based on traditional signal processing and sensor technology, not a learned model.

9. How the ground truth for the training set was established

• Not applicable/Not specified. As mentioned above, there is no "training set" for this type of device.

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