Search Results

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is for use by medical rofessionals or at home and is a 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 ann. The cuff circumference is imited to 22cm-48cm(be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one).

Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622. KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one), the device can analyze the signals promotly and display the test results.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arm Electronic Blood Pressure Monitor:

The document provides a 510(k) summary for the Andon Health Co., Ltd. Arm Electronic Blood Pressure Monitor. It asserts substantial equivalence to previously marketed devices and references compliance with certain standards for performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states the device meets the ANSI/AAMI SP-10 standard, which would contain specific numerical criteria for accuracy (e.g., mean difference and standard deviation between device readings and a reference method). However, these specific numerical performance results (e.g., mean difference in systolic/diastolic readings, standard deviation) are not explicitly reported in this summary. The summary only generally states compliance with the standard.

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

This information is not provided in the given document. The summary states that "Arm Electronic Blood Pressure Monitor ... meets the following standards: ANSI/AAMI SP-10 standard," which implies a clinical validation study was performed according to that standard. However, the details of that study, including sample size and data provenance, are absent from this 510(k) summary.

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

This information is not provided in the given document. For blood pressure monitors, the "ground truth" (reference measurements) for validation studies compliant with standards like ANSI/AAMI SP-10 typically involves a team of trained observers (e.g., physicians or nurses) taking auscultatory measurements using a mercury sphygmomanometer or validated oscillometric device, blinded to the device's readings. However, the specific number and qualifications of these experts are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the given document. In BP monitor validation studies, discrepancies between observers' readings (if multiple observers are used) usually follow a specific adjudication protocol, but this 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 to this device. The Arm Electronic Blood Pressure Monitor is a standalone measurement device, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed (and would not be relevant).

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

Yes, this is a standalone device. The entire validation described by its compliance with the ANSI/AAMI SP-10 standard is a standalone performance assessment of the device's algorithm and hardware against reference measurements. There is no "human-in-the-loop" interaction for interpreting the device's main output (blood pressure and pulse rate readings).

7. The Type of Ground Truth Used

The ground truth used for compliance with the ANSI/AAMI SP-10 standard would typically be concurrent auscultatory measurements taken by trained observers using a reference sphygmomanometer, specifically a mercury sphygmomanometer or another validated reference oscillometric device. These measurements are considered the "expert consensus" reference for blood pressure validation. The document states compliance with this standard, implying this type of ground truth was used.

8. The Sample Size for the Training Set

This information is not provided in the given document. For a traditional medical device like a blood pressure monitor, the "training set" doesn't typically refer to a large dataset for machine learning algorithms. Instead, it refers to data used during the development and calibration of the oscillometric algorithm. The specific size or nature of this data is not disclosed here.

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

This information is not provided in the given document. Similar to question 8, the "ground truth" for the development/calibration of the oscillometric algorithm would involve comparing the evolving device's readings against established reference methods, likely auscultatory measurements. However, the specifics of this process are not described in the 510(k) summary.

Ask a specific question about this device