(80 days)
KD-5902 Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's quide manual, which is same as predicated device.
KD-5902 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-5902 Fully Automatic Electronic Blood Pressure Monitor 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, the device can analyze the signals promptly and display the test results. It can storage and show 60 times measuring result with the day and time. Specially, it can speak them out. Besides, KD-5902 has the function of blood pressure classification indicator.
Here's a breakdown of the acceptance criteria and study information for the KD-5902 Fully Automatic Electronic Blood Pressure Monitor, based on the provided 510(k) summary:
The provided document is a 510(k) summary for a blood pressure monitor. As such, the "acceptance criteria" and "device performance" are typically framed around meeting established standards for blood pressure devices rather than detailed performance metrics. The study described is often a validation against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP-10 standard | The device "meets the following standards," explicitly listing ANSI/AAMI SP-10. This standard is specifically for automated sphygmomanometers and outlines accuracy requirements for blood pressure measurement. |
| EN60601-1 Medical electrical equipment Part 1: General requirements for safety | The device "meets the following standards," explicitly listing EN60601-1. This standard is for the general safety and essential performance of medical electrical equipment. |
| EN60601-1-2 Electromagnetic Compatibility | The device "meets the following standards," explicitly listing EN60601-1-2. This standard specifies requirements for electromagnetic compatibility of medical electrical equipment and systems. |
| Substantial Equivalence to Predicate Device (KD-595) | The document asserts "substantial equivalence" to the predicate device (KD-595, K070828) across various technological characteristics including indications for use, target population, design (similar), materials, performance, biocompatibility, mechanical safety, energy used, where used, standards met, and electrical safety. |
2. Sample Size and Data Provenance
The 510(k) summary does not explicitly state the sample size used for any specific test set related to the performance evaluation (e.g., for the ANSI/AAMI SP-10 validation). It only states that the device "meets the following standards."
The document does not provide any information regarding data provenance (e.g., country of origin of the data, retrospective or prospective) for any testing or validation.
3. Number and Qualifications of Experts for Ground Truth
The 510(k) summary does not mention the use of experts or their qualifications for establishing ground truth within the context of performance testing. Blood pressure monitor validation per ANSI/AAMI SP-10 typically involves a specific protocol with trained operators and validated reference devices, but the details of this are not provided in this summary.
4. Adjudication Method
The 510(k) summary does not describe any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study in the provided 510(k) summary. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with and without AI assistance. This device is a direct measurement device rather than an interpretive tool.
6. Standalone Performance Study
A "standalone" performance study would be the validation against the ANSI/AAMI SP-10 standard. While the summary states the device "meets" this standard, it does not provide the details or results of such a standalone study. It merely asserts compliance.
7. Type of Ground Truth Used
For a blood pressure monitor, the "ground truth" for performance validation (e.g., against ANSI/AAMI SP-10) is typically established by:
- Simultaneous measurement with a validated reference device: Often, this involves direct intra-arterial measurement or auscultation by trained observers using a mercury sphygmomanometer, calibrated according to the standard's requirements.
The 510(k) summary does not explicitly detail the specific method for establishing ground truth but implies it through adherence to the ANSI/AAMI SP-10 standard.
8. Sample Size for the Training Set
The 510(k) summary does not mention a training set sample size. This type of device is an algorithm-based measurement device, but its core function (oscillometric measurement) is based on well-established principles and does not typically involve a "training set" in the machine learning sense for its primary function. It's pre-programmed with an algorithm rather than "trained" on data post-manufacture in a way that requires a separate training set.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning, there is no information provided on how its ground truth was established.
§ 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).