(102 days)
KD-5920, KD-5920L and KD-5923 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-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
The provided text is related to a 510(k) premarket notification for a blood pressure monitor and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information necessary to fully complete all aspects of the requested table and study description regarding acceptance criteria and performance against those criteria as would be found in a clinical study report.
However, based on the available text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document references ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometers part 2: Clinical validation of automated measurement type as a standard met. This standard defines acceptance criteria for blood pressure measurement devices. While the exact acceptance criteria and the specific performance data against those criteria are not explicitly listed in a detailed table within the document, the mention of conforming to this standard implies that the device met its requirements.
The core acceptance criteria from ANSI/AAMI/ISO 81060-2:2009 typically involve:
- Mean difference: The absolute mean difference between the device measurements and auscultatory reference measurements should be ≤ 5 mmHg for both systolic blood pressure (SBP) and diastolic blood pressure (DBP).
- Standard deviation: The standard deviation of the difference between the device measurements and auscultatory reference measurements should be ≤ 8 mmHg for both SBP and DBP.
The document states: "None of the test demonstrates that KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness." and "KD-5920, KD-5920L and KD-5923 are very similar with its predicate device in the intended use, the design principle, the material, the performance...". This implicitly suggests that the device's performance aligns with the predicate device and meets the clinical validation standard's acceptance criteria. Specific numerical performance values are not provided in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Non-clinical Tests have been done as follows:" and then lists standards. For clinical validation, it specifically mentions conformance to ANSI/AAMI/ISO 81060-2:2009. This standard requires a specific sample size for its clinical validation protocol, typically aiming for at least 85 subjects (some sources suggest minimum 35 to 85, depending on the specific protocol variant, but 85 is common for AAMI).
- Sample size for test set: Not explicitly stated, but conformance to ANSI/AAMI/ISO 81060-2:2009 implies a sample size that meets the standard's requirements (typically at least 85 subjects).
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Clinical validation studies conforming to such standards are generally prospective.
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)
For blood pressure measurement validation according to standards like ANSI/AAMI/ISO 81060-2, ground truth is established by simultaneous auscultatory measurements performed by at least two trained observers (usually clinicians).
- Number of experts: At least two trained observers.
- Qualifications of experts: Typically clinicians or blood pressure technicians highly trained in auscultatory measurement, following a standardized protocol (e.g., mercurial sphygmomanometer with stethoscope, double-headed stethoscope, etc.). Specific experience (e.g., specific number of years) is not mentioned in this document but is implicitly part of being "trained observers" in such a protocol.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
For clinical validation of blood pressure devices using auscultation, the standard often involves:
- Two observers making simultaneous, blinded measurements.
- If the readings between the two observers differ by more than a predefined threshold (e.g., 4 mmHg), a third observer or a re-measurement may be required.
This is a form of consensus/adjudication. The specific method used (e.g., direct average of two, third observer if discrepancy) is not detailed but is part of the standard's methodology.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. Blood pressure monitors are inherently standalone devices that provide a measurement directly. The reference to ANSI/AAMI/ISO 81060-2:2009 confirms that the algorithm (device) performance was evaluated against a reference standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for blood pressure measurement validation is expert auscultatory measurements (often referred to as reference measurements) taken simultaneously by trained observers using a mercury or calibrated aneroid sphygmomanometer. This is a form of expert consensus / reference standard as defined by the AAMI/ISO standard.
8. The sample size for the training set
This document does not specify a separate "training set" sample size. The device is validated against the AAMI/ISO standard; blood pressure monitors typically undergo calibration and internal testing during development (which might use various datasets), but the primary clinical performance assessment for regulatory purposes is the validation study, not a distinct "training set" in the context of machine learning.
9. How the ground truth for the training set was established
As there is no explicitly mentioned "training set" in the context of the regulatory submission for this device type, the method for establishing its ground truth is not applicable or detailed in this document. The focus for regulatory submission is on the clinical validation/test 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).