(317 days)
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.
The arm blood pressure monitor model AES-U171, AES-U181, AES-U131 are sphygmomanometers with electronic manometer intended to be used for the indirect (noninvasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults who over the age of 12 (not for neonatal) . The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LCD panel.
The monitors AES-U171, AES-U181 and AES-U131 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance, and AES-U171 have print function.
The provided text describes the 510(k) summary for the Alicn Medical (Shenzhen), Inc. Arm Blood Pressure Monitor. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a detailed study report of a new, complex AI/ML device. Therefore, it does not fully align with all the requested subsections, especially those related to AI/ML specific criteria like MRMC studies, training set details, or complex ground truth establishment requiring multiple experts.
However, I can extract the relevant information regarding acceptance criteria and performance as presented for this type of medical device (a non-invasive blood pressure monitor) based on the principles of substantial equivalence and relevant standards.
Here's a breakdown of the information and how it relates to your request:
Acceptance Criteria and Study Details for the Arm Blood Pressure Monitor:
The primary acceptance criteria for this device, being a non-invasive blood pressure monitor, are defined by adherence to recognized international standards for accuracy and safety. The study proves the device meets these criteria by showing compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Reference) |
|---|---|
| Accuracy (Blood Pressure) | ±3mmHg (±0.4kPa) |
| (Based on ISO 81060-2) | "The performance test demonstrates the monitors meet the IEC 80601-2-30 and clinical test meets the ISO 81060-2." |
| Accuracy (Pulse Rate) | ±5% of reading |
| (Based on IEC 80601-2-30) | "The performance test demonstrates the monitors meet the IEC 80601-2-30 and clinical test meets the ISO 81060-2." |
| Electrical Safety | Compliant with IEC 60601-1:2005+Am1:2012 |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2:2007 (and apparently a later standard, though only 2007 is explicitly listed against the predicate) |
| Home Healthcare Environment | Compliant with IEC 60601-1-11:2015 |
| Specific Requirements for Blood Pressure Measurement | Compliant with IEC 80601-2-30:2009 |
| Waterproof (Ingress Protection) | IP21 (meets IEC 60601-1-11 requirement of at least IP21 for portable medical equipment in non-transit-operable use) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Eighty-six patients (43 males and 43 females) for the clinical test.
- Data Provenance: The document does not explicitly state the country of origin for the clinical test data, but the company is based in Shenzhen, China. The study is prospective, as it describes inviting patients for the study and conducting measurements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For non-invasive blood pressure monitors, the "ground truth" for accuracy is typically established by comparative measurements against a reference standard method, not by multiple human experts forming a consensus.
- In this case, the standard is the auscultation method, which is performed by healthcare professionals trained in its use. The document states: "Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm." The number and qualifications of the individuals performing the auscultation are not specified but are presumed to be appropriately trained medical personnel as per the ISO 81060-2 standard.
4. Adjudication Method for the Test Set:
- No "adjudication method" in the sense of multiple experts independently reviewing and then resolving discrepancies (common in imaging studies for AI/ML) is mentioned or relevant here. The ground truth is directly measured using a standard, established method (auscultation). The ISO 81060-2 standard itself outlines the comparison methodology.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI often used in diagnostic imaging, where multiple human readers review cases to assess diagnostic performance with and without AI assistance. This device is a direct measurement medical device (blood pressure monitor), not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, in essence, the primary performance evaluation of the device's accuracy is a standalone assessment. The device's measurements (systolic and diastolic BP, pulse rate) are compared directly against the reference standard (auscultation). While a human applies the cuff and initiates the measurement, the core measurement and algorithm for determining BP are intrinsic to the device, and its accuracy is evaluated independently of human interpretation of its output beyond simple reading.
7. The Type of Ground Truth Used:
- Reference Standard Measurement: The ground truth for blood pressure and pulse rate accuracy was established using the standard auscultation method, as mandated by ISO 81060-2. This is a direct comparative measurement rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
- This document describes a 510(k) submission for a non-AI/ML device. Therefore, there is no specific "training set" in the machine learning sense. The device's underlying algorithm for oscillometric blood pressure measurement is based on established principles and calibrated to meet the accuracy requirements of the relevant standards (ISO 81060-2, IEC 80601-2-30).
9. How the Ground Truth for the Training Set Was Established:
- As there is no distinct "training set" for an AI/ML algorithm, this question is not directly applicable. The device's design and calibration process would involve engineering and physiological principles to ensure accurate oscillometric measurements, rather than learning from a labeled dataset. The clinical testing described serves as validation that the developed device performs accurately against a gold standard.
§ 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).