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Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries. Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. Electronic Blood Pressure Monitor can be divided into three models (YJ320, YJ321E, YJ326E) according to their appearance and functions.

The provided text is for an FDA 510(k) clearance for an Electronic Blood Pressure Monitor. It details non-clinical and clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides a comprehensive table of non-clinical performance and safety acceptance criteria, along with the reported "Conclusion" (Pass/Fail). For the clinical validation, it states the acceptance criteria are met based on deviations from a reference standard.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Clinical Validation Acceptance Criteria (Simplified, based on ISO 81060-2:2018):

For the clinical study, the acceptance criteria are implicit in the statement: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018."

• Reported Device Performance: The device (YJ320) met these limits, indicating it performed within the required accuracy for blood pressure measurement against a reference standard.

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

• Test Set Sample Size:
  • Clinical Data: 86 adult subjects (49 females, 37 males).
  • Non-Clinical Data: Not explicitly stated as a "test set" in terms of subject count, but performance was evaluated based on the device itself and its components against established standards.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study participants or if it was retrospective or prospective. Given it's a 510(k) submission from a Chinese company, common practice would be for the clinical study to be prospective and likely conducted in China or a region where the standard is recognized.

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

• Clinical Ground Truth: The clinical validation was conducted according to ISO 81060-2:2018, which is "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard outlines specific methods for clinical validation, typically involving simultaneous measurements by trained observers (auscultation) against the automated device being tested. The number of experts (observers) involved in establishing the reference measurement (ground truth) is usually prescribed by this standard, but not explicitly stated in this summary. The standard generally requires at least two trained observers. Their qualifications would typically involve being trained and validated to perform accurate auscultatory blood pressure measurements.
• Non-Clinical Ground Truth: For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance limits set by the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993, IEC 80601-2-30). Test equipment and calibrated reference standards are used by technical personnel to verify compliance.

4. Adjudication method for the test set

• Clinical Data: The "Same Arm Sequential Method" was used as per ISO 81060-2:2018. This method involves taking sequential measurements from the same patient's arm using both the test device and a reference method (typically auscultation by trained observers). The standard itself dictates how discrepancies are handled and how the mean error and standard deviation of differences are calculated, which serves as the "adjudication" against the standard's limits. No explicit "expert adjudication" process like 2+1 or 3+1 is mentioned, as the standard relies on the statistical agreement of measurements.
• Non-Clinical Data: Not applicable in the context of expert adjudication for defining a "ground truth" in the same way as clinical or image-based studies. Tests are performed against objective criteria and measured by calibrated equipment.

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 type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. This device is an automated blood pressure monitor, not an AI diagnostic tool.

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

• Yes, the clinical validation study (ISO 81060-2:2018) is essentially a standalone performance assessment of the automated blood pressure monitor against a reference standard. The device's algorithm performs the measurement autonomously, and its output (systolic and diastolic pressure) is compared directly to the ground truth.

7. The type of ground truth used

• Clinical Ground Truth: The ground truth for blood pressure measurements in the clinical study was established by comparison with a reference method as defined by ISO 81060-2:2018. This standard typically refers to invasive measurements or, more commonly for non-invasive validation, simultaneous auscultatory measurements performed by trained observers. The document also states, "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018," which confirms adherence to this specific standard for ground truth establishment.
• Non-Clinical Ground Truth: The "ground truth" for non-clinical tests (e.g., accuracy, range, safety features) is based on the objective technical specifications and performance requirements outlined in referenced international standards, tested using appropriate calibrated measuring equipment.

8. The sample size for the training set

• This device is an Electronic Blood Pressure Monitor, which likely uses traditional signal processing and algorithms (oscillometric principle) rather than deep learning or AI that requires a "training set" in the modern machine learning sense. Therefore, a distinct "training set" of data for algorithm development, as seen in AI/ML medical devices, is not referenced or applicable here. The algorithms are based on established physiological principles and engineering.

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

• As explained in point 8, the concept of a "training set" as it applies to establishing ground truth for machine learning models is not relevant to this traditional medical device. The underlying algorithms are based on established physical and biological principles, and their accuracy is demonstrated through the clinical and non-clinical validation studies described.

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