(128 days)
KD-7901, KD-7905 and KD-7911 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 wrist. The cuff circumference is limited to 14cm-25cm.
KD-7901, KD-7905 and KD-7911 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 wrist. The cuff circumference is limited to 14cm-25cm.
It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmomanometers.
The operational principle is 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, the memory capability of KD-7901, KD-7905 and KD-7911 are 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.
The provided text indicates that the device is a Fully Automatic Electronic Blood Pressure Monitor (models KD-7901, KD-7905, and KD-7911) and that its performance conforms to several standards, including AAMI SP10:2002. However, the text does not directly state the specific acceptance criteria or report a direct "device performance" in terms of clinical accuracy (e.g., mean difference and standard deviation compared to a reference method) within a dedicated study section. Instead, it refers to conformity with standards.
Therefore, the response below will infer the acceptance criteria from the referenced AAMI SP10 standard and explain that a specific study showing "device performance" against these criteria is not explicitly detailed in the provided summary.
Acceptance Criteria and Device Performance Study for KD-7901, KD-7905, and KD-7911 Fully Automatic Electronic Blood Pressure Monitors
The provided 510(k) summary for the KD-7901, KD-7905, and KD-7911 Fully Automatic Electronic Blood Pressure Monitors states that the device conforms to several standards, including AAMI SP10:2002 (Manual, electronic or automated sphygmomanometers) and its amendments. The acceptance criteria for automated sphygmomanometers are generally defined within this standard.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from AAMI SP10:2002) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Accuracy (Mean Difference): Mean absolute difference between the device and reference standard should be ≤ 5 mmHg.* | The 510(k) summary states the device "conforms to... AAMI SP10:2002". No specific values for mean difference or standard deviation are provided in this summary. |
| Accuracy (Standard Deviation): Standard deviation of the differences should be ≤ 8 mmHg.* | No specific values for mean difference or standard deviation are provided in this summary. |
| Safety: Conformance to IEC 60601-1, IEC 60601-1-2. | Device conforms to IEC 60601-1 and IEC 60601-1-2. |
| Performance: General performance requirements as per AAMI SP10. | The summary lists "Performance: Similar" when comparing to the predicate device, and generally states the device "conforms to" AAMI SP10. |
*Inferred from general requirements of AAMI SP10 for automated sphygmomanometers for clinical accuracy. AAMI SP10 typically requires a clinical validation study to demonstrate these accuracy metrics.
Study Proving Device Meets Acceptance Criteria:
The 510(k) summary states that the device's performance conforms to ANSI/AAMI SP10--manual, electronic or automated sphygmomanometers (and its amendments). This implies that a study was conducted to demonstrate this conformity, as per the requirements of the standard, particularly for clinical accuracy. However, the details of this specific study (e.g., sample size, experts, ground truth, detailed results of mean difference and standard deviation) are not detailed within this 510(k) summary. The summary primarily focuses on demonstrating substantial equivalence to a predicate device (KD-795) by stating conformity to relevant standards and highlighting similarities in technological characteristics. The statement, "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," suggests tests were performed, but the results are not explicitly laid out.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided 510(k) summary. Compliance with AAMI SP10 typically requires a defined (e.g., usually N≥85 for clinical accuracy) sample size for validation.
- Data Provenance: Not specified in the provided 510(k) summary. Given the manufacturer's location (China), the study might have been conducted there, but this is not stated. The summary does not indicate if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified in the provided 510(k) summary. For AAMI SP10 validation, ground truth is typically established by trained human observers using a auscultatory reference method (e.g., mercury sphygmomanometer) following a standardized protocol.
4. Adjudication Method for the Test Set:
- Not specified in the provided 510(k) summary. For AAMI SP10 validation, typically two trained observers would independently measure blood pressure, and if their measurements differ by more than a specified amount, a third observer might be involved or the measurement discarded.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is not relevant for an automated blood pressure monitor, which measures blood pressure autonomously without human interpretation of results against a traditional diagnostic image or parameter where human readers are involved.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device is a "Fully Automatic Electronic Blood Pressure Monitor," which means its primary function is standalone measurement without human-in-the-loop performance affecting the measurement itself. The conformity to AAMI SP10 directly assesses this standalone performance against a human-observed reference.
7. The Type of Ground Truth Used:
- Based on conformity to AAMI SP10, the ground truth would have been established by expert auscultatory measurements (e.g., using a mercury sphygmomanometer) performed by trained observers. This is the standard reference method for validating automated blood pressure devices.
8. The Sample Size for the Training Set:
- Not applicable/Not specified. Automated blood pressure monitors (like this oscillometric device) are generally based on a defined algorithm and physical principles, rather than AI models that require extensive "training data" in the conventional machine learning sense. The device's algorithm is fixed and does not learn from a "training set" in the same way an image recognition algorithm would.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As explained above, these devices do not typically have a "training set" with associated ground truth in the context of machine learning. The algorithm's parameters might be derived from physiological models and empirical studies during development, but this is different from a machine learning training set.
§ 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).