(133 days)
It is intended for measuring adult blood pressure and pulse rate with circumference ranging from 135 mm to 215 mm.
Blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
The provided document describes a 510(k) premarket notification for a Blood Pressure Monitor (K141416). The acceptance criteria and the study proving the device meets these criteria are detailed, particularly in the section on "Testing data and clinical study" and the comparison table.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measurement Accuracy) | Reported Device Performance (K141416) | Predicate Device (K123498) Performance |
|---|---|---|
| Static pressure: ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) |
| Pulse accuracy: ±5% | ±5% | ±5% |
2. Sample size used for the test set and the data provenance
The document states that "Clinical study has been evaluated according to ANSI/AAMI SP10 and ANSI/AAMI/ISO 81060-2."
- ANSI/AAMI SP10 (Manual, electronic, or automated sphygmomanometers) typically requires a minimum of 85 subjects for clinical validation.
- ANSI/AAMI/ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type) specifies a clinical investigation with a minimum of 85 participants meeting certain age, gender, and blood pressure distribution requirements.
Based on the reference to these standards, it is highly probable that the study included at least 85 subjects. However, the exact sample size is not explicitly stated in the provided text.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided text. It is a clinical study, implying it was prospective, but this is not confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number of experts or their qualifications for establishing ground truth. Compliance with ANSI/AAMI SP10 and ANSI/AAMI/ISO 81060-2 for clinical validation typically involves reference measurements performed by trained observers (auscultatory method), but the specific details are not provided here.
4. Adjudication method for the test set
The document does not explicitly state any adjudication method for the test set. Compliance with ANSI/AAMI SP10 and ANSI/AAMI/ISO 81060-2 for clinical validation typically involves comparing device measurements against reference measurements taken by trained observers, where differences are analyzed. However, the specific method of handling discrepancies or consensus building is not detailed here.
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
This is not applicable. The device is a "Blood Pressure Monitor," which is an automated measurement device, not an AI-assisted diagnostic tool requiring human reader interpretation. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is standalone. It is a "Blood Pressure Monitor" that measures adult blood pressure and pulse rate automatically using an oscillometric method. Its performance is evaluated directly against reference measurements in clinical studies, without human intervention in the measurement process itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study would be established through reference blood pressure measurements obtained by trained observers using the auscultatory method, as per the requirements of ANSI/AAMI SP10 and ANSI/AAMI/ISO 81060-2. This is a form of expert reference measurement.
8. The sample size for the training set
The document does not provide any information regarding a specific "training set" or its size. For a medical device like a blood pressure monitor, manufacturers typically calibrate and develop their algorithms using internal data, but this is usually not referred to as a "training set" in the context of regulatory submissions the way it would be for an AI/ML device. The regulatory focus is on the clinical validation (test set) against established standards.
9. How the ground truth for the training set was established
Since there is no explicit mention of a "training set" in the context of this regulatory submission, there is no information on how its ground truth might have been established. Any internal development and calibration would have used methods consistent with blood pressure measurement best practices.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).