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The Automatic Talking Blood Pressure Monitor, Model BP3AP1-3E (BP A130) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

Microlife Automatic Talking Blood Pressure Monitor, Model BP3AP1-3E (BP A130) is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a capacitor pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol "Ar " is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, the device has talking function, traffic light and medication alarm function.

This device, the Microlife Automatic Talking Blood Pressure Monitor, Model BP3AP1-3E (BP A130), is a non-invasive oscillometric device intended to measure systolic and diastolic blood pressure and pulse rate in adults, with an added feature to detect irregular heartbeats.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to the ANSI/AAMI SP10: 2008 standard as the basis for clinical accuracy. While the specific numerical acceptance criteria from this standard are not explicitly stated in the document, it is a well-established standard for automated sphygmomanometers. For a device to meet this standard, its accuracy is typically evaluated against auscultatory measurements using a mercury manometer or another validated reference device.

The standard generally requires:

• Mean Difference (bias): For systolic and diastolic blood pressure, the mean difference between the device and the reference method should be within a certain threshold (e.g., ±5 mmHg).
• Standard Deviation of Differences: The standard deviation of the differences should also be within a specified limit (e.g., ≤ 8 mmHg).
• Number of Measurements within range: A certain percentage of measurements should fall within a predefined range (e.g., 5 mmHg, 10 mmHg, 15 mmHg) of the reference measurement.

Since "repeated clinical test in accordance with the standard ANSI/AAMI SP10 is not necessary" was stated due to no impact on accuracy, the reported device performance is essentially that it is considered to meet the ANSI/AAMI SP10:2008 standard based on its technical identity with a predicate device that was presumably tested against this standard.

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

The document does not specify a sample size for a test set for this particular device (BP3AP1-3E). It states that repeated clinical testing in accordance with ANSI/AAMI SP10 was not necessary because the device is considered technically identical to the predicate device (Model BP3MC1-PC) in terms of its blood pressure measurement algorithm and critical components.

However, it mentions "internal clinical tests comparing different cuff bladder material" and "clinical tests on three cuffs with different bladder size". No details about the sample size, data provenance (country of origin, retrospective/prospective), or methodology for these internal tests are provided.

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. Since new full clinical testing was deemed unnecessary, there's no mention of experts establishing a ground truth for a test set for this specific submission. For the predicate device, or for the "internal clinical tests" mentioned, it is typical for ground truth in blood pressure measurement to be established by trained observers (nurses, physicians, or technicians) using auscultatory methods with a mercury manometer, but this is not confirmed in the given text.

4. Adjudication method for the test set

This information is not provided. Given the lack of a detailed description of a new clinical test set for this device, an adjudication method is not mentioned.

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 automatic blood pressure monitor without AI assistance for human readers. Its primary function is to provide direct measurements rather than assisting human interpretation of images or complex data.

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

Yes, the device is designed to operate in a standalone manner, providing blood pressure and pulse rate measurements automatically via its oscillometric algorithm. The entire submission argues for "substantial equivalence" based on this standalone algorithm's performance being identical to a predicate device, which would have undergone standalone performance testing against a reference standard.

7. The type of ground truth used

For blood pressure monitors, the standard ground truth typically involves auscultatory measurements performed simultaneously by trained observers (often two or three) using a mercury manometer or another validated reference device. The document implies that the predicate device (Model BP3MC1-PC) and the "internal clinical tests" used this type of ground truth to establish accuracy against the ANSI/AAMI SP10 standard.

8. The sample size for the training set

The document does not provide information about a training set since this is not an AI/ML product developed with discreet training data. The "training" for the device's algorithm would have been part of the development process for the initial oscillometric algorithm, which is presumably the same as that used in the predicate device.

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

This information is not provided as there is no mention of a specific training set in the context of AI/ML development. The "ground truth" for the underlying oscillometric algorithm would have been established through traditional clinical validation studies using auscultatory reference measurements on human subjects, according to standards like ANSI/AAMI SP10.

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