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The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to 18.9" (22cm-48cm)

iHealth BPM1 Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. The new devices can connect to iOS or Andriod devices to show the results.

The provided text describes the iHealth Wireless Blood Pressure Monitor (BPM1) and its submission for 510(k) clearance. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of its performance against specific acceptance criteria.

However, based on the information provided, we can infer some aspects relevant to acceptance criteria and the "study" that proves the device meets them, largely through adherence to international standards and comparison to predicate devices.

Acceptance Criteria and Reported Device Performance

Study Details:

The document describes pre-market notification (510(k)) and focuses on demonstrating substantial equivalence rather than a new standalone clinical study for accuracy.

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

   • The document states: "Clinical data have been transferred from the predicates."
   • This implies that no new clinical test set was used for the BPM1 specifically for primary accuracy evaluation. Instead, the clinical data and performance of the predicate devices (Andon Health Co., Ltd. KD-927, K141984, KD-936, K120672, and KD-931, K102939) are relied upon.
   • The provenance of the original clinical data for the predicate devices is not specified (e.g., country of origin, retrospective or prospective).

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

   • Since clinical data were "transferred from the predicates," this information would pertain to the original studies for the predicate devices. This detail is not provided in the current document. Typically, accuracy studies for blood pressure monitors involve simultaneous measurements by trained observers (experts) using a reference method (e.g., mercury sphygmomanometer) and the device under test.

3. Adjudication method for the test set:

   • As clinical data were transferred, the adjudication method (if any) used for the predicate device studies is not described in this document. Standard blood pressure monitor accuracy studies often involve multiple observers performing auscultation and comparing their readings to ensure consensus or inter-observer reliability in establishing ground truth.

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, an MRMC comparative effectiveness study was not done. This device is a blood pressure monitor, which does not involve "human readers" interpreting images or data with or without "AI assistance" in the typical sense of MRMC studies. Its function is to provide direct measurements.

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

   • Yes, in essence, standalone performance was evaluated by adherence to IEC 80601-2-30. This standard specifically defines requirements for automated noninvasive sphygmomanometers, meaning the device's accuracy in measuring blood pressure is assessed independently of human interpretation of the measurement process itself. The device operates automatically to produce a reading.
   • The document mentions "Non-clinical Tests have been done as follows: ... c. Safety and performance characteristics of the test according to IEC 80601-2-30". This demonstrates standalone performance against established international standards.

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

   • For blood pressure monitors, the ground truth is typically established by simultaneous measurements by trained human observers using a validated reference method, such as a mercury sphygmomanometer, often following protocols like those outlined by the Association for the Advancement of Medical Instrumentation (AAMI) or the British Hypertension Society (BHS). This would be a form of expert reference measurement. As clinical data were transferred, this ground truth method would have been used for the predicate devices.

7. The sample size for the training set:

   • The document implies that the device's development and validation primarily relied on its similarity to predicate devices and adherence to standards. It does not explicitly mention a "training set" in the context of machine learning (AI) for this specific device's accuracy. The device uses an oscillometric principle, which is a well-established algorithm. Therefore, there isn't a "training set" in the typical AI sense to teach the device to measure blood pressure. The underlying algorithms are developed and refined based on extensive physiological and engineering data, but not a "training set" as one might see for image classification AI.

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

   • As there isn't a "training set" described for this device in the AI sense, this question is not directly applicable. The "ground truth" for the oscillometric method's development (which is the core of the device's function) would have been established through extensive research comparing oscillometric waveforms to directly measured intra-arterial pressures or auscultation by experts.

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