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This oscillometric blood pressure monitor is intended to measure the systolic blood pressure, pulse rate and mean arterial pressure (MAP) in people aged 3 years or older. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

This oscillometric blood pressure monitor is intended for measuring non-invasive blood pressure in people aged 3 years or older. It is clinically validated in patients with hypertension, hypotension, diabetes, pregnancy, pre-eclampsia, atherosclerosis, end-stage renal disease, obesity and the elderly. This device is intended to be operated by trained personnels only. Examples of trained operators include professional clinical and healthcare personnels.

The proposed device, oscillometric blood pressure monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure, pulse rate and mean arterial pressure of the person aged 3 years or older at upper arm within its claimed range and accuracy via the oscillometric technique.

The proposed oscillometric blood pressure monitor is available in one model, RBP 100.

Three sizes of cuffs are provided with proposed device, which are S size, M size and L-XL size: 1422cm; M size: 2232cm; L-XL size: 32~52cm).

The proposed device is intended to be used in medical facilities.

The provided text describes the regulatory clearance of an oscillometric blood pressure monitor (K190927) and references a clinical study conducted to demonstrate its accuracy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure monitor. The key performance acceptance criterion for such devices is accuracy as defined by the ISO 81060-2:2013 standard. This standard dictates limits for the difference between the device's measurements and reference measurements (typically from a mercury sphygmomanometer).

Note: While the document mentions "Blood Pressure Accuracy: ±3 mmHg" in the comparative table (Page 6), this is likely a more general specification for the device's internal accuracy, whereas the clinical validation against ISO 81060-2 is what demonstrates its performance in a clinical setting against a reference standard. The ISO standard has specific, more complex criteria involving mean difference and standard deviation of differences across subjects. The statement "The test results can meet the requirements of acceptance criteria and ISO 81060" confirms adherence to the ISO standard.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Adults: Three distinct groups were recruited: "Three 85 subjects (aged 54±19 years)", "33 subjects (aged 53±17 years)", and 41 children. It's unclear if the "Three 85 subjects" refers to 3 groups of 85, or if "85 subjects" is the total. However, the ISO 81060-2 standard typically requires a minimum of 85 subjects for a full validation. Given the multiple age ranges and types of subjects mentioned, it indicates efforts to cover the required demographic spread.
  • Children: 41 children (7.7±2.8 years).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It was a primary clinical study conducted for the predicate device (WatchBP, K101275) and re-used for the current device due to identical blood pressure models. The study was conducted retrospectively in relation to the current device's submission, but was likely a prospective study at the time it was originally performed for the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The context of the study is a comparison of an automated device against a reference method (likely a mercury sphygmomanometer as per ISO 81060-2). The "ground truth" for blood pressure measurements in such studies is established by trained oscillometric and auscultatory observers who follow strict protocols for manual blood pressure measurement to serve as the reference. The document does not specify the number or qualifications of these observers, but the adherence to ISO 81060-2 implies that appropriately trained personnel performed the reference measurements.

4. Adjudication Method for the Test Set

The study used the "same-arm sequential BP measurement method" which is a standard procedure in ISO 81060-2. This method involves taking alternating measurements from the test device and a reference device (e.g., a mercury sphygmomanometer) on the same arm. Adjudication in the typical sense (e.g., 2+1 or 3+1 reader consensus for imaging studies) is not applicable here as the ground truth is established by a direct physical measurement comparison. The ground truth itself is derived from the reference standard measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices where human readers interpret images with and without AI assistance. This submission pertains to a blood pressure monitor, which is a standalone measurement device, and the clinical study focuses on its measurement accuracy compared to a reference standard, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done

Yes, the clinical study performed for the predicate device (WatchBP) and referenced here is effectively a standalone performance study. The study evaluated the accuracy of the oscillometric blood pressure monitor in measuring blood pressure values compared to a reference standard, independent of human interpretation or intervention beyond operating the device. The device itself performs the measurement and outputs the values.

7. The Type of Ground Truth Used

The ground truth used was reference blood pressure measurements obtained from a standard method (implied to be auscultatory measurements using a mercury sphygmomanometer) as mandated by the ISO 81060-2:2013 standard. This is a form of empirical measurement ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device described is a traditional oscillometric blood pressure monitor, not an AI/ML-driven device that typically requires a large training dataset. The "blood pressure model" refers to the underlying algorithm or method for oscillating blood pressure measurement, which would have been developed and refined through engineering, calibration, and clinical validation, not necessarily "trained" in the machine learning sense. The clinical study described is for validation/performance, not for training.

9. How the Ground Truth for the Training Set was Established

As there's no mention of a "training set" in the context of an AI/ML model, the concept of establishing ground truth for a training set is not applicable here. The "blood pressure model" was likely developed based on known physiological principles of oscillometry and extensively tested/calibrated using controlled experimental setups and initial clinical trials (which are distinct from the final validation study mentioned).

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