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The HBP-2070 is intended to be used to monitor electrocardiography (ECG),heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressure) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR) temperature (Temp) for adult, pediatric, and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse, or medical specialist.

The proposed vital signs monitor is a modification of a previously cleared Colin Press Mate Advantage (K973637). The proposed model, HBP-2070, measures and monitors: Noninvasive blood pressure (NIBP), Oxygen saturation (SpO2), ECG, Respiration rate (RR), Heart Rate (HR), and Temperature.

1. Table of acceptance criteria and the reported device performance:

The provided document is a 510(k) premarket notification for the Omron HBP-2070, which aims to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are not explicitly stated as performance targets, but rather as alignment with or improvements over the predicate device's specifications. The "reported device performance" is the HBP-2070's specifications.

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

This document is a 510(k) premarket notification for a medical device (Omron HBP-2070 vital signs monitor). It primarily relies on demonstrating substantial equivalence to previously cleared predicate devices (K973637, K071645, K063690).

The document does not describe a specific clinical study with a test set of patient data for the HBP-2070 itself. Instead, it justifies its performance by stating that key modules (NIBP, SpO2) utilize components and/or algorithms from predicate devices that have already been cleared. For example:

• "Clange in the NIBP module to M3500 which has been used in our predicate HBP- T105 . (K071645)."
• "Change in the SpO2 module to Nell 3 which has been used and cleared in our predicate . BPS S510 (K063690)"

Therefore, there is no explicit mention of sample sizes for a new "test set" for the HBP-2070, nor data provenance (country of origin, retrospective/prospective) because the primary evidence for safety and effectiveness is through comparison to existing device approvals. Any performance data would have been generated and reviewed for the predicate devices.

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. As explained above, this submission relies on substantial equivalence to predicate devices, not on a new clinical study with expert-established ground truth for the HBP-2070.

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

Not applicable. There is no new test set described that would require an adjudication method.

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. The Omron HBP-2070 is a vital signs monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This is not explicitly stated as a standalone "algorithm only" study in the context of a software-based AI algorithm evaluation. However, the performance specifications listed in the table (e.g., accuracy of pressure indicator, HR accuracy, SpO2 accuracy, temperature accuracy) represent the device's intrinsic measurement capabilities, which are essentially "standalone" in their function to provide readings. These specifications are compared to those of the predicate devices. The "Software updates" mentioned are part of the overall device functionality, but not presented as a distinct AI algorithm subjected to separate standalone performance testing in this document.

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

The document does not detail the "ground truth" establishment for the predicate devices' evaluations, as it focuses on the HBP-2070's substantial equivalence to those devices. Typically, for vital signs monitors, ground truth for accuracy studies (which would have been conducted for the predicate devices) involves:

• NIBP: Invasive arterial blood pressure measurements (intra-arterial catheter) or simultaneous readings from another highly accurate, validated NIBP device.
• ECG/Heart Rate: Simultaneously recorded reference ECGs validated by cardiologists or a highly accurate reference heart rate counter.
• SpO2: Co-oximetry measurements from arterial blood samples.
• Respiration Rate: Visual counting by experts or capnography.
• Temperature: Calibrated reference thermometers.

The specific "ground truth" methodologies would have been part of the original 510(k) submissions for the predicate devices.

8. The sample size for the training set

Not applicable. This device is not described as an AI/ML algorithm that undergoes a distinct "training set" process. Its performance is based on established engineering principles and components from already cleared devices.

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

Not applicable, as there is no mention of a "training set" for an AI/ML algorithm in this submission.

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