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The HOSMAN USB Blood Pressure Monitor, Upper Arm Type: HM-500 and Wrist Type: HM-100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist or upper arm. The cuff circumference is limited to be 5.3'7.7' (13.5 cm19.5 cm) for wrist type; and 8.7'14.6' (22 cm37 cm) for Upper Arm type.

HOSMAN USB Blood Pressure Monitor Upper Arm Type: HM-500 and Wrist Type: HM-100 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

Here's an analysis of the provided text regarding the HOSMAN USB Blood Pressure Monitor's acceptance criteria and studies:

Acceptance Criteria and Device Performance

The device is a blood pressure monitor intended to measure systolic and diastolic blood pressure and pulse rate. The primary performance standard referenced for clinical accuracy is AAMI / ANSI SP10. This standard sets out accuracy requirements for automated sphygmomanometers. While the specific numerical acceptance criteria from AAMI/ANSI SP10 are not explicitly stated in the provided text, the document states that the device has undergone testing and that HOSMAN International Co., Ltd. "believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent..." to predicate devices. This implies that the device met the performance requirements outlined in AAMI/ANSI SP10.

Without the exact AAMI/ANSI SP10 criteria provided, we cannot create a precise table with specific values. However, we can infer the type of criteria based on the standard:

Details of the Study

The provided text offers very limited information regarding the clinical study, focusing primarily on regulatory compliance and substantial equivalence to a predicate device.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states that a "PERFORMANCE & CLINICAL TEST" was conducted according to AAMI/ANSI SP10.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. For AAMI/ANSI SP10, ground truth is typically established by trained observers using auscultatory methods with a mercury sphygmomanometer.

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

   • Not specified. The AAMI/ANSI SP10 standard usually involves multiple trained observers taking sequential measurements, but the specific adjudication method is not mentioned.

4. 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 MRMC or comparative effectiveness study involving human readers and AI was mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, implicitly. The "PERFORMANCE & CLINICAL TEST" according to AAMI/ANSI SP10 is a standalone performance evaluation of the device's accuracy in measuring blood pressure against a reference standard, without human-in-the-loop assistance in the measurement process itself.

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

   • The ground truth would have been established by reference blood pressure measurements taken concurrently by trained human observers using a validated method (historically, mercury sphygmomanometers) as per the AAMI/ANSI SP10 standard. This effectively functions as an "expert consensus" or "reference standard" for blood pressure.

7. The sample size for the training set:

   • Not applicable/Not specified. This device uses the oscillometric method, which is an algorithm embedded in the device. There's no mention of a "training set" in the context of machine learning for this particular device as described. The oscillometric algorithm itself is a pre-defined method, not typically "trained" on data in the modern AI sense for a 510(k) submission of this type.

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

   • Not applicable/Not specified, as there is no mention of a training set or machine learning model in the contemporary sense. The oscillometric principle is a physiological measurement method.

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