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K Number
K051847
Device Name
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
Manufacturer
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO.,
Date Cleared
2006-01-05

(182 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The KD-768 Wrist Measurement 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 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

Device Description

KD-768 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 120 times measuring result with the month, day and time of measuring.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the KD-768 Wrist Measurement Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance CriteriaReported Device Performance
Accuracy requirements of ANSI/AAMI SP10-1992"The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992."

Study Details

The provided text describes clinical tests that were performed to comply with the accuracy requirements of ANSI/AAMI SP10-1992. However, it does not provide specific details on many of the requested categories.

Here's what can be extracted and what is not available in the provided text:

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

    • Sample Size: Not specified.
    • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

  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 specified. For blood pressure monitors, the "ground truth" often refers to reference measurements (e.g., auscultatory method by trained observers). The text does not elaborate on this.

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

    • Not specified.

  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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor and does not involve AI or human readers in the context of diagnostic interpretation.

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

    • Yes, a standalone study was done. The "clinical tests" described, focusing on compliance with ANSI/AAMI SP10-1992, assess the device's accuracy in measuring blood pressure independently. The device itself is an automated system for measurement.

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

    • The "ground truth" for blood pressure monitor accuracy studies typically involves simultaneous measurements using a recognized reference standard, such as Riva-Rocci/auscultatory method performed by trained observers, as specified by standards like ANSI/AAMI SP10. The text does not explicitly state this, but compliance with ANSI/AAMI SP10-1992 implies such a method for ground truth.

  7. The sample size for the training set:

    • Not applicable/Not specified. This device is a physical measurement device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "clinical tests" described are for validation of the device's accuracy rather than training an algorithm.

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

    • Not applicable. (See point 7).

§ 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).