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The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.

The Wrist Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa.

All the models included in this submission follow the the same intended use, same measurement principle, same blood pressure core algorithm and similar product design. All the models can be used with one cuff size 13.5~19.5 cm (5.3-7.7inches).

The main differences are appearance, Dimensions and some specifications which will not affect the safety and effectiveness of the device.

The provided FDA 510(k) clearance letter and associated summary pertain to a Wrist Blood Pressure Monitor, which is a medical device for measuring blood pressure and pulse rate. It is not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study designs associated with AI/SaMD (such as multi-reader multi-case studies, ground truth establishment by experts, training set details, or effect sizes of AI assistance) are not applicable to this device.

The acceptance criteria and study details provided are tailored to the performance of a non-invasive blood pressure measurement system (hardware device), focusing on accuracy, safety, and effectiveness.

Here's a breakdown of the requested information based on the provided document, addressing the device's specific characteristics as a hardware blood pressure monitor:

Acceptance Criteria and Device Performance (Wrist Blood Pressure Monitor)

1. Table of Acceptance Criteria and Reported Device Performance

As per the 510(k) summary, the device's accuracy is a key performance metric. The acceptance criteria are based on the international standard ISO 81060-2 Third edition 2018-11 [Including AMD1:2020].

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

• Sample Size for Test Set (Clinical Accuracy Study):
  • Three groups of clinical accuracy research were conducted. Each group included 100 subjects, for a total of 300 subjects across the 13 models.
  • Group 1: 100 subjects (47 Male, 53 Female)
  • Group 2: 100 subjects (54 Male, 46 Female)
  • Group 3: 100 subjects (44 Male, 56 Female)
  • Minimum subjects for each group was 85, as per ISO 81060-2.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. However, the manufacturer is "Shenzhen AOJ Medical Technology Co., Ltd." in Shenzhen, Guangdong, China. It is highly probable the data was collected in China.
• Retrospective or Prospective: The clinical accuracy study, designed to meet ISO 81060-2, is typically conducted prospectively to collect new data for device validation. The wording "clinical accuracy research" and "clinical accuracy test report and data analysis followed the requirements" implies a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not directly applicable in the context of this device because "ground truth" for a blood pressure monitor's accuracy is established against a reference standard, not through expert consensus on interpretations of images or signals (as would be the case for AI/SaMD).
• For blood pressure monitors, the "ground truth" or reference measurement is typically taken by trained medical professionals using a standardized reference sphygmomanometer (e.g., mercurial or auscultatory method), as per the ISO 81060-2 standard. The document states "The Same Arm Sequential Method was chosen for all studies," which is a standard procedure comparison method against a reference device. The qualifications of the individuals performing these reference measurements would be trained clinicians (e.g., physicians, nurses).

4. Adjudication Method for the Test Set

• This question is not applicable for a blood pressure monitor's accuracy testing. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in human expert interpretations, especially in image-based diagnostics.
• For blood pressure accuracy, deviations are quantified statistically between the device reading and the reference measurement, not through an adjudication process among multiple "readers."

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, this was not done. This type of study is relevant for AI/SaMD devices where AI assists human interpretation and is a key component for assessing the AI's clinical utility. The Wrist Blood Pressure Monitor is a standalone hardware device that provides a measurement; it does not involve human "readers" interpreting data or AI assistance.

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

• Yes, in essence. The entire clinical accuracy study described in Section 8 ("Clinical data") evaluates the device's performance (which incorporates its internal oscillometric algorithm) in a standalone manner against a reference standard. The "algorithm" here refers to the embedded software that processes the oscillometric signals to derive blood pressure and pulse rate. The study directly assesses how accurately the device (with its integrated algorithm) measures blood pressure readings compared to the reference.
• Performance Metrics: The evaluation was based on the "mean error and standard deviation of differences for systolic, diastolic pressure" as per ISO 81060-2.

7. The Type of Ground Truth Used

• The ground truth for the clinical accuracy testing was established through concurrent measurements using a standardized reference method (e.g., auscultatory method with a mercurial sphygmomanometer or another validated reference device) on the same arm, sequentially with the test device. This is the standard for blood pressure monitor validation as per ISO 81060-2.
• It is not "expert consensus" in the sense of subjective medical interpretation, but rather an objective, standardized measurement performed by trained personnel using a calibrated reference instrument.

8. The Sample Size for the Training Set

• This concept is not applicable to this type of medical device clearance. The Wrist Blood Pressure Monitor is a hardware device with an embedded algorithm (oscillometric technique) that is based on established physiological principles. It doesn't use machine learning or deep learning in a way that requires a separate "training set" of patient data for an AI model to learn from, as would be the case for AI/SaMD devices. The device's "training" (development and calibration) would involve engineering principles and laboratory testing, rather than a data-driven machine learning process.

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

• As the concept of a "training set" in the context of machine learning is not applicable here (see point 8), the establishment of ground truth for such a set is also not applicable. The device's underlying measurement principle is well-established oscillometric technology. Development and calibration rely on physical models and engineering validation.

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