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The HEM-4030 is a digital monitor intended for measuring systolic and diastolic blood pressure and pulse rate in adults.

The Omron HEM-4030 is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Environment of Use: Home

The HEM-4030 is a non-invasive blood pressure monitor that determines blood pressure by the oscillometric method. The cuff is manually inflated by the user with a squeeze bulb. The device is powered by 2 "AAA" batteries. It is a minor modification of the Omron - HEM-405C - 510(k) K903133 non-invasive blood pressure monitor.

Here's an analysis of the provided text regarding the Omron HEM-4030, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Summary for a modified medical device. This typically means that a full clinical trial for performance is often not required if the changes do not impact the fundamental scientific technology or performance. The document explicitly states this: "As there are no changes in hardware or software that will impact performance there is no need to validate the changes through a clinical investigation." and "There are no changes to the blood pressure or pulse rate algorithms." Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study may not be present for this specific submission. Instead, the focus is on verification activities for the modifications.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Performance Testing" but does not explicitly provide the quantitative acceptance criteria for each and the specific reported performance values for the new HEM-4030 against those criteria. It states that "the results demonstrated that the predetermined acceptance criteria were met."

However, we can infer some general performance areas from the "Performance Testing Performed" table. For a non-invasive blood pressure monitor, the primary acceptance criteria would typically relate to the accuracy of blood pressure and pulse rate measurements. Since the blood pressure and pulse rate algorithms were not changed from the predicate device (Omron HEM-405C - K903133), it is implied that the performance of these key metrics is considered equivalent to the predicate.

Regarding the "Study that proves the device meets the acceptance criteria":

For this specific 510(k) submission (K110501), the "study" is described as "Verification activities, as required by the risk analysis, for the modification were performed..."

The core argument for not requiring a new clinical investigation is that:

• The device is a minor modification of a previously cleared device (Omron HEM-405C - K903133).
• The modifications do not change the intended use or alter the fundamental scientific technology.
• There are no changes to the blood pressure or pulse rate algorithms.

Therefore, the "proof" is based on engineering verification testing to ensure the specific modifications (e.g., changes to environmental specs, physical dimensions, memory, battery, software to support changes, cuff material, high BP indicator) function as intended and do not negatively impact the performance of the core blood pressure/pulse rate measurement functionality, which is inherited from the predicate device.

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

• Sample Size for Test Set: The document does not specify a sample size for the verification tests listed in Table 5.1. Given that these are primarily engineering verification activities for modifications rather than a clinical performance study, the "sample size" might refer to the number of units tested or specific test cases rather than a patient cohort.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Typically for engineering verification, data is generated internally through controlled testing environments.

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided.

For engineering verification, "ground truth" is often established by adherence to product specifications, industry standards, and internal quality control processes, rather than through expert clinical consensus in the way a diagnostic AI device might. As the blood pressure algorithm itself was not changed, the "ground truth" for its accuracy would refer back to the predicate device's clearance and underlying studies, which are not detailed here.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not provided. Given the nature of engineering verification tests, a clinical adjudication method (like 2+1, 3+1) is generally not applicable. Test results are typically compared against predefined specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states that "there is no need to validate the changes through a clinical investigation" and that "There are no changes to the blood pressure or pulse rate algorithms." Therefore, there is no AI component, and no study comparing human readers with and without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: No, a standalone study on a new blood pressure or pulse rate algorithm was not done. The submission explicitly states "There are no changes to the blood pressure or pulse rate algorithms." The device relies on the performance of the algorithm from its predicate device. The verification activities focus on ensuring the modified hardware/software supports this existing algorithm correctly.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the performance tests (e.g., pressure measurement accuracy, blood pressure measurement accuracy, pulse rate accuracy), the ground truth for blood pressure and pulse rate would typically be established against a reference standard (e.g., sphygmomanometer readings by trained observers, ECG for pulse rate) as per recognized clinical measurement protocols (like AAMI or ISO standards) for the predicate device. For the verification of the modifications (e.g., memory, display, indicators, battery), the ground truth would be the device specifications themselves (i.e., does the feature work as designed/specified?).

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not applicable/not provided. This device is a non-AI, non-diagnostic blood pressure monitor. It uses an oscillometric algorithm, which is a pre-programmed method, not a machine learning model that requires a "training set" in the AI sense. The algorithms are inherited from the predicate device and were not changed.

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

• How Ground Truth for Training Set was Established: This information is not applicable/not provided. As explained above, the device does not use an AI/machine learning model in the sense that it requires a "training set" with established ground truth. The algorithms are based on established oscillometric principles.

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