Search Results

iHealth Track Blood Pressure Monitor(KN-550BT) is for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic 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 limited to 22cm-48cm.

iHealth Track Blood Pressure Monitor(KN-550BT) is and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. The new devices achieves its function by LCD or iOS/Andriod devices.

The provided text describes the iHealth Track Blood Pressure Monitor (KN-550BT) and its substantial equivalence to a predicate device. It references performance testing against specific standards but does not detail specific acceptance criteria or the full study results in a format that directly answers all aspects of your request.

Here's an attempt to extract and infer the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device conforms to several IEC standards. For blood pressure monitors, the primary performance standard is typically IEC 80601-2-30. This standard defines the accuracy requirements for automated non-invasive sphygmomanometers. While the document doesn't explicitly state the acceptance criteria values or show a table of results against those criteria, it implies compliance with the standard is the acceptance criterion.

Based on IEC 80601-2-30 (which is the standard the device claims to conform to), the typical accuracy requirements for blood pressure (systolic and diastolic) are:

• Mean difference: ≤ ±5 mmHg
• Standard deviation: ≤ 8 mmHg

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Non-clinical Tests have been done" and lists the standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For blood pressure monitor accuracy testing against a standard like IEC 80601-2-30, ground truth is typically established by trained technicians or clinicians using a calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer, auscultatory method). The document does not specify the number or qualifications of experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. For blood pressure accuracy testing, adjudication is less common than for, say, image interpretation. The comparison is usually directly between the device reading and the reference standard.

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 typically associated with AI algorithms used in image interpretation, assessing how AI assistance impacts human readers. The iHealth Track Blood Pressure Monitor is a standalone measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance tests described are implicitly standalone. The device (KN-550BT) measures blood pressure and pulse rate directly. The stated "Safety and performance characteristics of the test according to IEC 80601-2-30" refer to the device's accuracy in autonomously measuring these parameters.

7. The Type of Ground Truth Used

For blood pressure monitoring, the ground truth is typically established through simultaneous or closely coordinated measurements using a recognized reference method, such as a mercury sphygmomanometer with auscultation, performed by trained observers. The document does not explicitly state "ground truth," but this is the standard practice for the IEC 80601-2-30 testing it references.

8. The Sample Size for the Training Set

The concept of a "training set" is generally applicable to machine learning algorithms. While the device uses "oscillometric and silicon integrates pressure sensor technology" and calculates values, it's not described as an adaptable machine learning system that requires a distinct training phase with a labeled dataset for its core function. Therefore, a training set in the typical AI/ML sense is likely not applicable or not disclosed for this type of device.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, a "training set" in the context of AI/ML is likely not applicable here, or it refers to general engineering and calibration data rather than a distinct machine learning training phase. The core technology relies on established physical principles of oscillometry. Therefore, the establishment of ground truth for a training set is not discussed.

Ask a specific question about this device