Search Results

KD-513LJ Fully Automatic Electronic 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 and system and is a rate of an adult individual by using a non-invasive technique in which and system one shound the supper and the supper and the supper and The cuff circumference is limited to 22cm-48cm.

KD-513LJ Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC80601-2-30--manual, electronic or automated sphygmanometers.

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 irreqular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. Achieves its function by an LCD .

The provided text is a 510(k) premarket notification for a medical device, specifically a Fully Automatic Electronic Blood Pressure Monitor (Model KD-513LJ). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document states that the device adheres to international standards for safety and performance, which act as the acceptance criteria. The performance summary explicitly mentions conformity to:

• IEC 60601-1:2005/EN 60601-1:2006/AC:2010: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010: Medical electrical equipment - Part 1-2: Electromagnetic compatibility.
• IEC 80601-2-30:2009+Cor.2010/EN 80601-2-30:2010: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

These standards contain detailed specifications for accuracy, safety, and performance of blood pressure monitors. The document asserts that the device conforms to these standards, implying that it meets their respective acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

The document (specifically Section 8.0 "Discussion of non-clinical and clinical test performed") focuses on non-clinical tests performed to demonstrate safety and effectiveness. It does not describe a clinical study in the traditional sense of evaluating accuracy against a gold standard or a specific patient population, but rather conformance to recognized performance standards.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not provide information on the sample size for any clinical test set.
   • It does not specify the data provenance (country of origin, retrospective/prospective).
   • The "tests" mentioned are regulatory compliance tests (e.g., Electromagnetic compatibility, Electrical safety, Safety and performance characteristics of the test according to IEC 80601-2-30), not clinical performance studies with patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. The tests discussed are engineering and compliance tests against established standards, not studies requiring expert interpretation of medical images or measurements to establish a ground truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. As the tests are for regulatory compliance with standards, adjudications like those in clinical trials for diagnostic devices are not described.

4. 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. This device is a blood pressure monitor, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC study is not relevant and was not performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The device itself is a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner to measure blood pressure. The "tests" (IEC 80601-2-30) evaluate its performance in this standalone capacity against reference standards. So, in a sense, the compliance testing is evaluating its standalone performance as a medical device. However, it's not a "standalone algorithm" in the context of AI without human interaction.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For blood pressure monitors, the "ground truth" for accuracy testing, typically required by standards like IEC 80601-2-30 for clinical validation, involves simultaneous measurements by a trained observer using a "reference" auscultatory method (e.g., Korotkoff sounds with a mercury or calibrated aneroid sphygmomanometer). The document does not explicitly state the specific ground truth method used for the performance testing, but implies compliance with IEC 80601-2-30, which mandates such a clinical validation.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/machine learning device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. As there is no "training set" for this type of device, this question is not relevant.

In summary, the document primarily focuses on demonstrating substantial equivalence to a predicate device and conformity to established international safety and performance standards for non-invasive blood pressure monitors. It does not detail specific clinical trial data or AI model validation methods.

Ask a specific question about this device