(163 days)
KD-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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-388N, KD-5031L, KD-5031M, KD-5031N, KD-525EN, KD-575N. KD-5917D, KD-5917N, KD-595B, KD-5961B, KD-5963NG, KD-559 and KD-516 Fully Automatic Electronic Blood Pressure Monitor are 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.
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. Achieves its function by an LCD.
The provided document is a 510(k) Premarket Notification from the FDA for a Fully Automatic Electronic Blood Pressure Monitor. It does not describe an AI medical device or provide the level of detail necessary to answer all parts of your request regarding AI acceptance criteria and study proving performance. The document focuses on showing substantial equivalence to a predicate blood pressure monitor.
However, I can extract information related to the device's performance validation as a non-AI medical device, based on the provided text.
Here's how I can address your request based on the available information, highlighting what is not applicable (N/A) for this type of device or not provided in the document:
1. A table of acceptance criteria and the reported device performance
The document states the device conforms to several standards, one of which is highly relevant for performance:
- ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type
This standard defines the acceptance criteria for clinical validation of automated non-invasive sphygmomanometers. While the document states the device will conform, it does not provide the specific reported performance data against these criteria in a table. It simply asserts compliance.
Therefore, for this device (a blood pressure monitor), the acceptance criteria would be those laid out in the ANSI/AAMI/ISO 81060-2:2009 standard. The document states compliance, but the specific performance results (e.g., mean difference and standard deviation of blood pressure readings compared to a reference method) are not explicitly listed in the provided text.
2. Sample size used for the test set and the data provenance
The document mentions clinical validation according to ANSI/AAMI/ISO 81060-2:2009. This standard typically requires a specific number of subjects (e.g., often a minimum of 85 subjects for the main validation) evenly distributed across different blood pressure ranges.
- Sample Size: Not explicitly stated in the provided text, but implied to be sufficient to meet the ANSI/AAMI/ISO 81060-2:2009 standard.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Clinical validation studies for medical devices are generally prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For a blood pressure monitor, the "ground truth" is typically established by trained observers using a reference method (e.g., auscultation with a mercury sphygmomanometer).
- Number of Experts: Not explicitly stated, but typically involves two or more trained observers to establish reference measurements according to the validation standard.
- Qualifications of Experts: Not explicitly stated, but they would be clinicians/technicians trained in standardized blood pressure measurement techniques.
4. Adjudication method for the test set
For blood pressure validation studies, adjudication often involves averaging readings from multiple trained observers after ensuring inter-observer agreement.
- Adjudication method: Not explicitly stated, but implied to follow the methodology of ANSI/AAMI/ISO 81060-2:2009, which involves obtaining simultaneous or very close reference measurements from trained observers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, this is not applicable for a standalone blood pressure monitor. MRMC studies are typically for image-based diagnostic devices where human readers interpret images with and without AI assistance. This device is an automated measurement system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the fundamental performance evaluation of an automated blood pressure monitor is inherently "standalone" in that it measures blood pressure without direct human interpretation of a reading (other than taking the measurement itself). The validation according to ISO 81060-2 is a direct assessment of its accuracy against a gold standard.
7. The type of ground truth used
- Ground Truth Type: Clinical reference measurements from trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or another validated oscillometric device, as per the AAMI/ISO standard).
8. The sample size for the training set
The concept of "training set" is typically associated with machine learning/AI models. For a traditional medical device like this, there isn't a "training set" in the AI sense. The device's algorithms for blood pressure measurement are developed and refined during R&D, not typically "trained" on a data set in the same way an AI model is.
- Training Set Sample Size: N/A (not an AI device).
9. How the ground truth for the training set was established
Since there is no "training set" in the AI context applicable to this device, this question is N/A.
In summary, the provided document is for a traditional, non-AI medical device. While it states compliance with relevant performance standards (like ANSI/AAMI/ISO 81060-2:2009), it does not provide the detailed study results or address AI-specific questions like training sets, MRMC studies, or multi-expert ground truth establishment for AI.
§ 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).