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ZSBP-001 and ZSBP-002 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old.

ZSBP-101 series of blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old.

All measurement values can be read out and keep memory on the LCD panel for home care use.

Basically two different type of blood pressure monitors are to be included in this 510(K) submission, the wrist type and upper arm type. The main intended use for these two tvpe of blood pressure monitor is as the following description:

1> ZSBP-001 and ZSBP-002 blood pressure monitor. This series of device measures automatically the human being systolic, diastolic blood pressure and heart beat rate from wrist by using the oscillometric method for the patient of ages above 18 years old.

2> ZSBP-101 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age above 18 tears old.
For all of these three blood pressure monitors, the measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician).

From the construction point of view, the non-invasive electronic blood pressure monitor was composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at upper arm or wrist, pneumatic pumping inflation and deflation system, housing, display LCD, and measuring software, and memories ....... etc.

The main operation for the non-invasive electronic blood pressure monitor is carried out in such a way that the measuring cuff at wrist or upper arm is inflated to the set pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective to time were recorded as the database of measurement. Then the following measuring results will be calculated against the measurement database, and displayed on the LCD of device:

Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)
Heart beat rate.

In addition to the main blood pressure and heart beat rate measuring function, the ZSBP series of blood pressure monitor provides also the memory function for user to store the result of measurement.

The provided text is a 510(k) summary for a blood pressure monitor, not an AI/ML medical device. Therefore, much of the requested information, such as details about AI model training, test sets, ground truth establishment, and MRMC studies, is not applicable or present in this type of document.

However, I can extract the information that is relevant to the acceptance criteria and the study performed, based on the provided text.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with established voluntary standards. The document explicitly mentions:

• ANSI/AAMI SP 10-1992: This standard specifies requirements for automated sphygmomanometers.
• EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

The document states that the "representative models of ZSBP-001 and ZSBP-101 were chosen as testing samples" to demonstrate conformity with these standards.

The "reported device performance" is summarized by the conclusion that the devices "maintain the same safety and effectiveness as that of cleared devices" (the predicate devices) and that the engineering differences "do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device."

Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information (and why it's mostly not applicable here):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not provided in the 510(k) summary. For a blood pressure monitor, testing would typically involve clinical validation studies (e.g., following AAMI protocols) to establish accuracy against a reference method (like auscultatory measurement by trained observers). The 510(k) summary only states "representative models... were chosen as testing samples" for standard compliance. It does not mention the number of subjects or the data provenance for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable in this context. Blood pressure monitor validation relies on comparison to a gold standard measurement (often auscultation by trained technicians/physicians), not expert consensus on images or other subjective data. The document does not provide details on the personnel involved in the testing process or their qualifications.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where there's an element of human interpretation and potential disagreement (e.g., reading medical images). For a blood pressure monitor, the "ground truth" and device measurements are objective numerical values.

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:

   • Not applicable. This is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant to this device.

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

   • This device is a standalone algorithm (an oscillometric method, though not an AI algorithm) for measuring blood pressure. Its "performance" is its accuracy in measuring blood pressure compared to a reference standard, as implicitly covered by compliance with ANSI/AAMI SP 10-1992. The document confirms that "measurement values can be read out and keep memory on the LCD panel for home care use( without the involvement of professional physician)." This indicates it's intended for standalone use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For blood pressure monitors, the gold standard (ground truth) is typically an invasive intra-arterial measurement or, more commonly in non-invasive validation, simultaneous auscultatory measurements taken by trained observers using a mercury sphygmomanometer (or an equivalent validated device). The document itself does not explicitly state the ground truth method used beyond referencing compliance with ANSI/AAMI SP 10-1992, which dictates such validation methods.

8. The sample size for the training set:

   • Not applicable. This device uses the "oscillometric method," which is a well-established signal processing technique for detecting blood pressure. It is not an AI/ML device that requires a "training set" in the modern sense.

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

   • Not applicable, as there's no AI/ML training set in this context.

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