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WA400 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician)

AA300 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 individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).

Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on,

The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base :

Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)

Heart beat rate.

For this submission, two different type of blood pressure monitors are to be included in this 510(K) submission, the wrist type/model WA400 and upper arm type/model AA300. The main intended use for these two type of blood pressure monitor is as the description of the following section:

In addition to the main blood pressure and heart beat rate measuring function, the WA400 and AA300 blood pressure monitors provide also the memory function for user to store the result of measurement. AA300 also provides the USB connection port for the transformation of measuring data.

The provided text does not contain detailed information about a study that proves the device meets specific acceptance criteria beyond stating compliance with voluntary standards and software verification. There is no mention of a clinical trial with a defined test set, ground truth establishment, or expert involvement. The submission appears to rely on substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested details cannot be extracted from the given information.

However, based on the provided text, we can infer some general acceptance criteria and the nature of the "study" that supports substantial equivalence.

Inferred Acceptance Criteria and Reported Performance (Based on Substantial Equivalence and Compliance to Standards):

Details Not Available in the Provided Text:

• Sample size used for the test set and the data provenance: Not explicitly stated. The "verification and validation tests" are mentioned but no specifics about the test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no independent expert-based ground truth establishment for a test set is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no adjudication process is mentioned for defining ground truth.
• 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, as this is a blood pressure monitor, not an AI-assisted diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone blood pressure monitor (algorithm only performance essentially). However, the "study" described is about establishing equivalence to a predicate, not necessarily a de novo clinical performance study against a reference standard.
• The type of ground truth used: Not explicitly stated for a performance study. For substantial equivalence, the "ground truth" is implied to be the performance and safety characteristics of the predicate device as established by its clearance and adherence to standards like ANSI/AAMI SP 10-2002.
• The sample size for the training set: Not applicable, as there's no mention of a machine learning model being "trained" in the context of this traditional medical device. The "measuring software" used the Oscillometric method, which is a well-established algorithm, not typically "trained" on a dataset in the modern AI sense.
• How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary of the "Study" (Based on the 510(k) Summary):

The core "study" proving the device meets acceptance criteria is primarily a substantial equivalence comparison to two predicate devices (Zen Strong models ZSBP-001 and ZSBP-101, both cleared under K070473).

The key elements of this "study" are:

1. Comparison of Intended Use: Demonstrated that the WA400 and AA300 have the same intended use as their respective predicate devices.
2. Comparison of Technical Characteristics: Asserted that the WA400 and AA300 share similar technical characteristics with their predicates.
3. Compliance with Voluntary Standards: Stated that the devices comply with ANSI/AAMI SP 10-2002, EN 60601-1, and EN 60601-1-2. These standards typically define accuracy requirements and testing protocols for blood pressure monitors.
4. Software Verification: Confirmed that software verification was carried out according to FDA guidance.
5. Verification and Validation Tests: General mention of "verification and validation tests" to demonstrate that any engineering differences do not affect intended use or alter fundamental scientific technology, thus maintaining the same safety and effectiveness as the cleared predicate devices. No details about the specific methodology, sample sizes, or results of these tests are provided in this summary.

In essence, the "study" is a justification that the new devices are so similar to already cleared devices that they can be presumed safe and effective without requiring a full de novo clinical effectiveness trial. The acceptance criteria are therefore largely met by demonstrating adherence to recognized performance standards (like ANSI/AAMI SP 10-2002) and functional equivalence to the predicates.

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