(139 days)
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 2232cm(8.712.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.
The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique. The Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm32cm (8.7in12.6in).
The document is a 510(k) Pre-market Notification for a Digital Blood Pressure Monitor. It describes the device's characteristics, intended use, and comparison to a predicate device. The clinical validation data provided is specifically for demonstrating the accuracy of the blood pressure monitor.
Here's an analysis of the provided text to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are based on ISO 81060-2:2013, which specifies the requirements for clinical validation of automated non-invasive sphygmomanometers. The document states that the device's accuracy is "within acceptable scope specified in ISO 81060-2."
While ISO 81060-2 provides specific statistical criteria (mean difference and standard deviation of differences between the device and reference measurements), the document does not explicitly list these numerical criteria or the exact calculated performance metrics but rather makes a summary statement of compliance.
However, a "Substantial Equivalence Comparison" table (Table 1) provides the following for the subject device and predicate device:
| Characteristic | Subject device (Digital Blood Pressure Monitor-Automatic Upper Arm Style) | Predicate device (Arm Blood Pressure Monitor - K150430) |
|---|---|---|
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±5mmHg; Pulse ±5%. |
Note: The accuracy characteristic listed as "Pressure: ±3mmHg; Pulse: ±5%" for the subject device seems to be a design specification or internal target, rather than reported clinical performance data resulting from the ISO 81060-2 study. The ISO standard specifies a statistical method to declare accuracy, not a simple range. The statement under section 9 "Brief discussions of clinical tests" that "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2" is the key clinical performance outcome. Without the specific numerical results (mean difference and standard deviation) from the ISO 81060-2 test, a precise performance table cannot be constructed from this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Eighty-seven (87) patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for this purpose.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- For blood pressure accuracy studies following ISO 81060-2, "experts" in the traditional sense of image interpretation for AI are not typically involved in establishing ground truth.
- Ground Truth: The ground truth for blood pressure measurements is established by a manual Mercury Sphygmomanometer as the reference device, with measurements performed by trained personnel according to the standard. The document states: "The manual Mercury Sphygmomanometer was used as a reference device."
4. Adjudication Method for the Test Set
- Adjudication Method: The document describes a "Same arm sequential method" for the clinical testing. This is a specific protocol for comparing automated blood pressure readings to a reference standard, not an adjudication method in the context of multiple human readers for AI. It implies direct comparison of measurements taken immediately after each other.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This study is for the clinical validation of a blood pressure monitor's accuracy against a standard, not an AI-assisted diagnostic device where human reader improvement would be measured.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in essence. The validation described is for the device (the automated blood pressure monitor) itself, which functions as a standalone algorithm (oscillometric technique) to measure blood pressure without human interpretation of complex data (like medical images). It's comparing the device's automated readings to a reference standard.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established using a manual Mercury Sphygmomanometer as the reference device. This falls under the category of a reference standard method (a gold/silver standard where applicable) for physiological measurements.
8. The Sample Size for the Training Set
- Not Applicable/Not Provided: This document describes the clinical validation of a physical medical device (blood pressure monitor), not an AI/machine learning model where a distinct "training set" would be used for algorithm development. The device's underlying oscillometric algorithm is presumably developed and optimized by the manufacturer using internal methods, but this document does not detail that process or any "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable/Not Provided: As mentioned above, this document does not refer to a training set for an AI model. The "ground truth" for the device's function is inherent in its design and the physical principles of oscillometry, calibrated and validated against established standards.
§ 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).