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Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.

The intended use of this over-the counter device is for adult patients whose arm circumference is between 24-32cm (approx. 9.4" to 12.6").

H&L Full Automatic (NIBP) Blood Pressure Monitor

The provided text is a 510(k) premarket notification letter from the FDA for a non-invasive blood pressure measurement system (HL888BA). It confirms substantial equivalence but does not contain details about specific acceptance criteria, study design, or performance metrics beyond the general function of measuring blood pressure and heart rate.

Therefore, most of the requested information cannot be extracted from the given document.

Here's what can be gathered, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be determined from the provided text. The document states the device measures systolic, diastolic blood pressure, and heart rate, but it does not specify performance metrics (e.g., accuracy, precision) or acceptance criteria for those metrics.

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

• Cannot be determined from the provided text.

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/Cannot be determined from the provided text. This type of device (non-invasive blood pressure monitor) typically does not rely on expert consensus for "ground truth" in the same way an imaging AI device would. Its accuracy is usually validated against a reference standard (e.g., a mercury sphygmomanometer) and not expert interpretations.

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

• Not applicable/Cannot be determined from the provided text. No adjudication method would be relevant for this type of device's validation.

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/Cannot be determined from the provided text. This is a standalone diagnostic device. There is no "human reader" component or AI assistance involved in the measurement process itself.

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

• Yes, implicitly. A blood pressure monitor fundamentally operates as a standalone device to measure blood pressure and heart rate. Its performance evaluation would be based on its ability to accurately measure these parameters without human interpretation during the actual measurement. However, the results of such a study are not provided.

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

• Cannot be determined from the provided text. For a blood pressure monitor, the ground truth would typically be established by a validated reference method, such as a mercury sphygmomanometer or an invasive arterial line, which is then used to compare the device's readings. The document does not specify this.

8. The sample size for the training set

• Not applicable/Cannot be determined from the provided text. This is a non-AI medical device; therefore, there isn't a "training set" in the context of machine learning. The device is based on established oscillometric principles.

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

• Not applicable. See point 8.

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