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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult and pediatric (> 3 year old) patient population with arm circumference ranging from 5 inches to 20 inches (from 12 cm to 50 cm). The device also detects the appearance of irregular heartbeats during measurement. Model -- HBP-1300 for prescriptive use by qualified medical personnel in hospitals, acute care settings, outpatient surgery, healthcare practitioner facilities.

The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump then deflates the cuff via an electronically controllable valve. During deflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure. The device is intended to be used with specified Omron cuffs in five sizes to encompass arms ranging from 5 to 20 inches in circumference. The device also detects the appearance of irregular heartbeats during measurement.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size: 50 adults and 35 children.
• Data Provenance: Not explicitly stated, but the study was conducted to demonstrate clinical accuracy against a recognized standard (ANSI/AAMI/ISO 81060-2), implying clinical data from patients. No information on country of origin or whether it was retrospective or prospective is provided.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the document. For blood pressure measurement, the ground truth is typically established by trained technicians using a reference method (e.g., auscultation with a sphygmomanometer) during the clinical study.

4. Adjudication Method

• This information is not provided in the document. For blood pressure clinical trials, multiple trained observers often take measurements simultaneously with the automated device to establish a robust ground truth, and if there are discrepancies, an adjudication method might be used for the reference measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not mentioned. This type of study is more common for diagnostic imaging AI systems where human readers interpret images with and without AI assistance. This device is a non-invasive blood pressure monitor, not an imaging device.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was implicitly done. The "Performance Testing" section states: "Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2. This testing was performed on 50 adults and 35 children with results showing compliance to the standard." This refers to the device's (algorithm's) ability to accurately measure blood pressure on its own.

7. Type of Ground Truth Used

• Clinical Reference Standard: The ground truth for the accuracy testing was established in accordance with ANSI/AAMI/ISO 81060-2. This standard typically involves simultaneous measurements by trained observers using a reference method (often auscultation) as the ground truth against the device under test.

8. Sample Size for Training Set

• This information is not provided in the document. The document describes pre-market testing for a physical device with embedded software, not necessarily a machine learning model that requires a distinct "training set" in the modern AI sense. If the device's algorithm was developed using data, that detail is not included.

9. How Ground Truth for Training Set Was Established

• This information is not provided as a "training set" in the AI context isn't explicitly mentioned or applicable based on the provided text. The device uses an oscillometric technology, which is a well-established method for blood pressure measurement, rather than a novel AI algorithm requiring extensive training data documentation in this submission.

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