(270 days)
The KD-622 Fully 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 8.6614 inches to 13.78 inches.
KD-622 Fully Automatic Electronic 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. Swathing the air cuff around the left upper arm 1-2cm above elbow joint 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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, presented in the requested format:
The provided text for K030358, the KD-622 Fully Automatic Electronic Blood Pressure Monitor, is a 510(k) summary and FDA clearance letter. It primarily describes the device, its intended use, and claims substantial equivalence to a predicate device. While it mentions "Clinical Tests" and "accuracy requirements of ANSI/AAMISP10-1992", it does not provide detailed information about the acceptance criteria or the study methodology, sample sizes, expert qualifications, or ground truth establishment for that study.
Therefore, most of the requested information cannot be extracted directly from the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10-1992 Accuracy requirements for non-invasive sphygmomanometers (This standard defines accuracy requirements for both systolic and diastolic blood pressure measurements) | "The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992." |
2. 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 in the provided document.
- Data Provenance: Not specified in the provided document. The clinical tests were performed to comply with ANSI/AAMI SP10-1992. The submitter is a Chinese company, so the tests were likely conducted in China, but this is not explicitly stated. It is standard for these types of studies to be prospective, but this is not confirmed in the text.
3. 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)
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document. For blood pressure monitors, "experts" typically refers to trained observers following a standardized protocol (e.g., using a reference sphygmomanometer) as outlined by standards like ANSI/AAMI SP10.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the provided document. ANSI/AAMI SP10 typically involves a comparison against a reference method by independent observers, with predefined criteria for acceptable differences between readings.
5. 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
- MRMC Comparative Effectiveness Study: Not applicable. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, as the device is an automatic blood pressure monitor, its performance is considered standalone. The "Clinical Tests" mentioned assess its ability to accurately measure blood pressure on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for blood pressure measurement studies typically involves simultaneous measurements by trained observers using a highly accurate, calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a standardized protocol as outlined in ANSI/AAMI SP10. The readings from the reference device are considered the "true" blood pressure against which the device under test is compared.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As a traditional medical device (non-AI/ML), there isn't a "training set" in the machine learning sense. The device is based on established oscillometric principles and calibrated during manufacturing. The "clinical tests" are for validation, not training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the reasons stated above (non-AI/ML device).
§ 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).