(73 days)
KD-5903, KD-5909 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 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.
KD-5903, KD-5909 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 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.
KD-5903 and KD-5909 are all designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle of KD-5903 and KD-5909 are based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, If any irreqular heartbeat is detected, it can be shown on the LCD. The memory capability of KD-5903 is 3×40 times, the memory capability of KD-5909 is 2×60 times.
This document describes the KD-5903 and KD-5909 Fully Automatic Electronic Blood Pressure Monitors, which are non-invasive blood pressure measurement systems.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure monitors generally stem from standards like ANSI/AAMI SP10. While the document mentions conformance to ANSI/AAMI SP10, it does not explicitly state the specific numerical acceptance criteria (e.g., mean difference and standard deviation limits for blood pressure measurements) within this summary.
However, the document states:
- "Performance: Identical" when comparing the KD-5903/KD-5909 to the predicate device KD-591.
- "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies that performance was evaluated and found to be acceptable.
Without the specific numerical limits from ANSI/AAMI SP10, a direct table of acceptance criteria vs. reported performance cannot be fully constructed from the provided text. The summary confirms that the devices "conforms to the following standards: AAMI SP10:2002..." which implicitly means they meet the performance requirements of that standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "the test in this submission provides demonstration." A typical blood pressure monitor validation study following AAMI SP10 would involve a specific number of subjects (e.g., at least 85 subjects with specific blood pressure ranges).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for the test set. For blood pressure monitor validation, this typically involves trained observers taking auscultatory measurements according to a standardized protocol, sometimes with double-blinded readings.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable here as this is astandalone automated blood pressure monitor and not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire premise of the submission is to demonstrate that the KD-5903 and KD-5909 devices perform comparably to their predicate device and meet relevant standards (e.g., AAMI SP10) without human intervention in the measurement process. The statement "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness" confirms this.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For non-invasive blood pressure monitors, the ground truth is typically established by simultaneous auscultatory measurements performed by human observers using a reference sphygmomanometer, often following a highly standardized protocol (e.g., AAMI SP10 and ISO 81060-2 require comparison to mercury sphygmomanometer readings).
8. Sample Size for the Training Set
This device is not an AI/ML algorithm that is deep-learning based and requires a distinct training set. The performance is based on an oscillometric principle, which relies on a pre-defined algorithm and not a learnable model in the context of typical AI/ML systems. Therefore, the concept of a "training set sample size" as used for AI/ML is not applicable here.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and "ground truth for the training set" is not applicable in the context of this traditional oscillometric blood pressure monitor.
§ 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).