(173 days)
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is six sizes.
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for a blood pressure monitor. It serves as a regulatory approval and states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the necessary safety and effectiveness standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AGE Automatic Upper Arm Blood Pressure Monitor are primarily established by compliance with recognized standards for safety and performance. The document explicitly states the required accuracy for pressure and pulse measurements.
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance | Verdict (as stated in document, usually "SE" for Substantial Equivalence) |
|---|---|---|
| Accuracy (Pressure): ±3 mmHg | Pressure: ±3 mmHg | SE |
| Accuracy (Pulse): ±5% | Pulse: ±5% | SE |
| Measuring Method | Oscillometry (same as predicate) | SE |
| Measurement Range for Pressure | 0~280 mmHg (same as predicate) | SE |
| Operating Range for Pressure (Cuff Pressure) | 0~280 mmHg (same as predicate) | SE |
| Cuff Display Range | 0~280 mmHg (same as predicate) | SE |
| Pressure Resolution | 1mmHg or 0.1kPa (same as predicate) | SE |
| Patient Population | Adult (same as predicate) | SE |
| Measurement Site of Body | Upper Arm (same as predicate) | SE |
| Inflation and Deflation | Automatic (same as predicate) | SE |
| Electrical, Mechanical and Thermal Evaluation | Compliance with IEC 60601-1, IEC 60601-1-2 | SE |
| Biocompatibility Evaluation | Compliance with ISO 10993-5, -10 | SE |
| Performance Standard | Compliance with ISO 81060-2 | SE (Note 5 states it's equivalent to AAMI SP10 used by predicate) |
| Intended Use & Indications for Use | Same as predicate (with minor cuff circumference difference, addressed in Note 1) | SE |
| Power Supply | DC 6V (4 X AA 1.5V alkaline batteries) (Substantially equivalent to predicate) | SE |
| Memory Size | 2 x 90 sets record (BA-822X is 90 sets) (Note 2 states differences do not affect safety/effectiveness) | SE |
| Software Version | V01 (Note 3 states it's updated based on predicate, no change in PWB control circuit) | SE |
| Operating & Storage Conditions | Temperature, Humidity, Atmospheric Pressure ranges (Note 2 states minor differences do not affect safety/effectiveness) | SE |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the device's safety and performance were evaluated by "lab bench testing" and "clinical validation" according to ISO 81060-2.
- Sample Size: The document does not specify the precise sample size used for the clinical validation. ISO 81060-2, the standard followed, dictates specific subject requirements for clinical validation of automated sphygmomanometers (e.g., specific age groups, blood pressure ranges, and a minimum number of subjects, typically at least 85 subjects with appropriate distribution). However, the number of subjects used in this specific study is not provided in the excerpt.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it's a 510(k) submission for a device manufactured in China, it's plausible the clinical study was conducted in China or another region that uses ISO standards, likely a prospective study to collect human blood pressure measurements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to compliance with ISO 81060-2 for clinical validation. This standard typically requires "reference measurements" (ground truth) to be obtained by healthcare professionals using a standardized method (e.g., mercury sphygmomanometry with a stetho-scope).
- Number of Experts: ISO 81060-2 usually requires at least two trained observers (experts) for simultaneous, blind auscultatory measurements to establish the reference blood pressure. The document itself does not specify the exact number of experts.
- Qualifications of Experts: The standard implies that these experts are trained and competent in auscultatory blood pressure measurement. While "radiologist with 10 years of experience" is an example qualification, for blood pressure measurement, the standard would typically require medical professionals trained in auscultatory blood pressure measurement, such as physicians, nurses, or trained technicians, without specifying years of experience in this excerpt.
4. Adjudication Method for the Test Set
For the clinical validation against ISO 81060-2, the ground truth is established by simultaneous auscultatory measurements by two trained observers.
- Adjudication Method: While not explicitly detailed, ISO 81060-2 requires a pre-defined method for handling discrepancies between the two observers' readings. Common methods include:
- Averaging the two readings if they are within a specific tolerance.
- Using a third, independent observer if the initial two readings differ by more than a specified amount (e.g., 2+1 methodology).
- No adjudication is typically not acceptable for establishing ground truth in this type of study; a consensus or defined reconciliation process is necessary to minimize observer bias. The exact method used for this device's validation is not detailed in the provided text.
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
- No, an MRMC comparative effectiveness study was not done. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improving with AI assistance" is not applicable. The study's purpose was to validate the accuracy of the automated device itself against a human-read reference standard.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in spirit, a standalone performance study was done. The device itself is an automated system that measures blood pressure. The clinical validation conducted under ISO 81060-2 assesses the accuracy of the device's algorithm (its automated measurement) compared to the "gold standard" of human-observed auscultatory blood pressure. There isn't a "human-in-the-loop" in the operation of the device for each measurement; it's designed to be automated.
7. The Type of Ground Truth Used
- The ground truth for the clinical performance evaluation (per ISO 81060-2) would be expert consensus auscultatory blood pressure measurements, typically performed simultaneously and blindly by two trained observers using a mercury sphygmomanometer or equivalent calibrated device. This is the accepted clinical gold standard for such validations.
8. The Sample Size for the Training Set
- Not applicable / Not provided. This document describes a 510(k) submission for a traditional medical device (an automated blood pressure monitor) that operates based on oscillometric principles, not explicitly on machine learning or deep learning algorithms that require separate "training sets." The device's underlying algorithm is likely fixed and validated, not something that "learns" from a training dataset in the AI sense. Therefore, there's no mention of a "training set" as one would find for an AI/ML medical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As explained in point 8, this device does not appear to utilize a machine learning model that would require a "training set" with established ground truth in the context of AI/ML development. Its accuracy is validated against a reference standard in a clinical study.
§ 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).