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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)

Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

Here's a breakdown of the acceptance criteria and the study details for the Electronic Blood Pressure Monitor, model: HTD6602US, based on the provided document:

Acceptance Criteria and Device Performance

Note: The primary acceptance criteria for accuracy are based on compliance with ISO 81060-2 Third Edition 2018-11, as indicated in the "Performance" row of the comparison table and the discussion of clinical accuracy testing. The specific numerical accuracy values are explicitly stated in the comparison table.

Study Details

The study that proves the device meets the acceptance criteria is a clinical accuracy test.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 85 subjects
• Data Provenance: Not explicitly stated, but since the submission is by Hetaida Technology Co., Ltd. from China and it's a 510(k) submission to the US FDA, it likely refers to a prospective clinical trial conducted to meet ISO standards. The document doesn't specify if the subjects were from a particular country.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The document refers to "reference equipment" (Sphygmomanometer - Stethoscope health box) and "Measuring Method: Auscultatory," which implies measurements were taken by trained personnel (e.g., medical professionals, technicians) using a standard, validated auscultatory method simultaneously with the device being tested.
• Qualifications of Experts: Not explicitly stated. However, for auscultatory measurements to establish ground truth in blood pressure studies, the personnel typically need to be trained clinicians or technicians adhering to standardized measurement protocols.

4. Adjudication Method for Test Set

• Adjudication Method: Not explicitly stated, but the method used for "ground truth" is "Auscultatory" measurements. In clinical blood pressure validation studies following ISO 81060-2, this usually involves at least two trained observers taking simultaneous readings (often blinded to each other's readings) and resolving discrepancies. The document mentions "Reference equipment used for measurements," implying a direct comparison to established, validated manual methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, this type of study is not applicable to a non-invasive blood pressure monitor that directly measures physiological parameters. MRMC studies are typically used for diagnostic imaging devices where human readers interpret images.

6. Standalone Performance Study

• Was a standalone (algorithm only without human-in-the-loop performance) study done? Yes, the entire clinical accuracy study evaluates the device's (algorithm's) performance in measuring blood pressure and pulse rate autonomously against a gold standard (auscultatory measurements). The device operates without human interpretation of its internal measurements; it directly provides readings.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus via Auscultatory Measurement Method using a reference Sphygmomanometer - Stethoscope health box. This is the gold standard for clinical validation of automated blood pressure devices.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable or not provided. This device is a hardware-based measurement system with an embedded algorithm, not a machine learning model that typically has a distinct training phase with labeled data in the same way. The algorithm's development (training) phase would occur during the device's engineering and calibration, not necessarily with a separate "training set" as understood in modern AI/ML contexts.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable. As noted above, this isn't a typical AI/ML model where a training set with established ground truth is used for iterative learning. The accuracy of the device's algorithm would be refined through engineering and calibration processes based on physiological principles and potentially internal testing, not a "training set" of patient data in the same sense. The ISO 81060-2 clinical trial serves as the validation of the finalized algorithm's performance against clinical ground truth.

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