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The device is a digital monitor for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 inches to 7 1/4 inches (12.8 cm to 18.5 cm).

RA-T59 Wrist blood pressure monitor is designed to measure the blood pressure and pulse rate of adults within the range of the designated wrist cuff (12.8 to 18.5 cm). RA-T59 Wrist blood pressure monitor is based on an oscillometric method to measure blood pressure and pulse rate from wrist. The device uses automatic inflation mode. It starts to inflate from 0 mmHg and automatically stops the motor after 25 seconds and quickly deflates, with a steady inflation speed detecting the measurement during inflation. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The signal from the electronic pressure sensor is conditioned with a circuit before data conversion by an analog-to-digital converter (ADC). The systolic pressure, diastolic pressure, and pulse rate are then calculated in the digital domain. The resulting systolic, diastolic, and pulse-rate measurements are displayed on a LCD and stored in the device's memory.

Here's a breakdown of the acceptance criteria and study information for the RA-T59 Wrist blood pressure monitor, based on the provided document:

Acceptance Criteria and Reported Device Performance

The device's performance for blood pressure measurement is evaluated against the requirements of ISO 81060-2:2018. The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in a quantitative manner as one might find in a detailed study report. However, it states that "The results of this clinical investigation show that the proposed device fulfills the requirement of ISO 81060-2:2018."

The key performance criterion for blood pressure monitors, based on the Accuracy or pressure indicator and Accuracy Pulse Rate sections in the comparison table (page 4), is:

Note: While the document confirms compliance with ISO 81060-2:2018, specific numerical results (e.g., mean difference and standard deviation between device and reference measurements) that demonstrate this compliance are not provided within this summary for either systolic or diastolic blood pressure, or pulse rate.

Study Information

2. Sample size used for the test set and the data provenance:

• Sample Size: 85 qualified healthy adult subjects.
• Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "clinical investigation," which generally implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For blood pressure clinical validation studies like ISO 81060-2, ground truth is typically established by trained and certified observers using a validated reference sphygmomanometer, not usually by "experts" in the context of interpretation (like radiologists). The standard specifies requirements for the observers.

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

This information is not provided in the document. For blood pressure measurements in clinical validation, ground truth is typically established by two (or more) independent observers. The standard ISO 81060-2:2018 outlines the methodology for taking concurrent auscultatory measurements by these observers.

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, an MRMC comparative effectiveness study was not done. This device is an automated blood pressure monitor and does not involve human readers interpreting results or AI assistance in that context. The study performed was a clinical validation of the device's measurement accuracy.

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

Yes, a standalone performance study was done. The clinical investigation directly assessed the RA-T59 Wrist blood pressure monitor's (algorithm and hardware) ability to accurately measure blood pressure and pulse rate against a reference standard in a clinical setting, without human interpretation of the device's output.

7. The type of ground truth used:

The type of ground truth used is implied by the adherence to ISO 81060-2:2018. This standard typically establishes ground truth through concurrent auscultatory measurements performed by trained observers using a reference sphygmomanometer. This is a form of expert-derived, objective measurement used as the "truth" against which the automated device's readings are compared.

8. The sample size for the training set:

The document does not mention a training set sample size. This is a clinical validation document for a medical device that measures physiological parameters, not a machine learning or AI algorithm in the typical sense that would have an explicit "training set" for model development. The "clinical investigation" mentioned is for validation, not training.

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

As no training set is mentioned in the context of this device, this question is not applicable.

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