(136 days)
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.
Fully Automatic Electronic Blood Pressure Monitor (KD-5810, KD5810B, KD-5811, KD-5920TL and KD-552) 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 describes a 510(k) premarket notification for Andon Health Co., Ltd.'s Fully Automatic Electronic Blood Pressure Monitor. The document indicates that the device's accuracy was verified by meeting criteria 1 and 2 of ISO 81060-2. However, the text does not explicitly provide a table of acceptance criteria and reported device performance for the subject device itself. Instead, it refers to prior clinical test reports for predicate devices (KD-5961, BP3, and BP5) as references.
Therefore, not all requested information can be extracted directly for the subject device from the provided text. I will answer based on the information available and will highlight where specific details are not provided for the subject device but are referenced through predicate devices.
1. A table of acceptance criteria and the reported device performance
The provided text states that the accuracy of the blood pressure monitors in the clinical test reports was verified by meeting Criteria 1 and Criteria 2 of ISO 81060-2. However, it does not provide a specific table with numerical acceptance criteria and the reported performance for the subject device models (KD-5810, KD-5810B, KD-5811, KD-5920TL, and KD-552). It refers to the clinical test reports of predicate devices.
Based on general knowledge of ISO 81060-2, the criteria typically involve:
ISO 81060-2 Criteria (General Reference, not explicitly stated in document for subject device):
| Acceptance Criteria (ISO 81060-2:2009) | Reported Device Performance (Reference to predicate studies) |
|---|---|
| Criterion 1: Mean difference and standard deviation | Not explicitly stated for the subject device. The document states that the clinical test reports of the predicate devices met these criteria. |
| The mean difference between the device measurements and reference measurements should be within ±5 mmHg. | |
| The standard deviation of the differences should be ≤ 8 mmHg. | |
| Criterion 2 (for device approval for general population): Distribution of individual differences | Not explicitly stated for the subject device. The document states that the clinical test reports of the predicate devices met these criteria. |
| For SYS/DIA, 65% of the differences should be within ±5 mmHg. | |
| 85% of the differences should be within ±10 mmHg. | |
| 95% of the differences should be within ±15 mmHg. |
2. Sample size used for the test set and the data provenance
For the subject devices (KD-5810, KD-5810B, KD-5811, KD-5920TL, and KD-552), the text does not explicitly state the sample size used for the test set or the data provenance directly for these devices.
It states:
- "The proposed devices KD-5810, KD-5810B, KD-5811 and KD-5920TL has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961can be used as a reference when considering the clinical effect of KD-5810, KD-5810B, KD-5811 and KD-5920TL."
- "The proposed devices KD-552 has the same algorithm and design principle with cleared device BP3 (K102939) and BP5 (K120672), so the clinical test report of BP3 (K102939) and BP5 (K120672) can be used as a reference when considering the clinical effect of KD-552."
To determine the sample sizes and data provenance, one would need to access the clinical test reports for K083246 (KD-5961), K102939 (BP3), and K120672 (BP5). The provided document does not contain this information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical studies mentioned (those for KD-5961, BP3, and BP5). For blood pressure measurement validation studies, ground truth is typically established by trained observers (e.g., physicians or nurses) using a sphygmomanometer following a standardized protocol (such as auscultation with a mercury sphygmomanometer or an equivalent reference device).
4. Adjudication method for the test set
The text does not specify an adjudication method for the test set. In blood pressure validation studies, ground truth is usually established by highly trained technicians or physicians taking multiple reference readings, and often, paired readings are averaged or discrepancies between two observers are reconciled, but these specific methods are not described in this document.
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
The device described is a Noninvasive Blood Pressure Measurement System. This type of device is not typically evaluated using MRMC studies as it is a standalone measurement device, not an interpretive imaging or diagnostic system where human readers interpret results. Therefore, this section is not applicable. The document does not describe any MRMC studies or human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the clinical validation referenced through the predicate devices (KD-5961, BP3, BP5) would assess the standalone performance of the algorithm in measuring blood pressure against a reference standard. The text states: "Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2." This implies a standalone performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood pressure monitors validated against ISO 81060-2, the "ground truth" (or reference measurement) is typically established by simultaneous or sequential measurements taken by trained observers using a calibrated reference sphygmomanometer (e.g., mercury or an equivalent validated device) using the auscultatory method. This is a direct expert measurement, not pathology or outcomes data.
8. The sample size for the training set
The provided text does not provide any information regarding a "training set" or its sample size. Blood pressure monitors like this typically use established algorithms (oscillometric method) and are validated against clinical standards rather than being "trained" in the machine learning sense with a distinct training set. If the algorithm involved machine learning, this information would be critical, but the description ("operational principle is based on oscillometric and silicon integrates pressure sensor technology") suggests a traditional signal processing approach.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided document. The ground truth for the validation (test) set would be established as described in point 7.
§ 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).