(245 days)
The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia).
The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.
Cuff supporting the use of Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(K151290).
The provided text describes the 510(k) summary for the AVICHE Automatic Digital Blood Pressure Monitor (K210152). Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Standard or Predicate) | Reported Device Performance (K210152) |
|---|---|
| BP Accuracy: ± 3 mmHg (ISO 81060-2:2018) | ± 3 mmHg |
| BP Range: Comparable to predicate (0-300 mmHg) | 0-280 mmHg |
| PR Range: Comparable to predicate (40-200 beats/min) | 40-199 beats/min |
| Pulse Accuracy: ± 5% of reading value | ± 5% of reading value |
| Electrical Safety: Complies with IEC 60601-1 | Complies with IEC 60601-1 |
| Home Use Compliance: Complies with IEC 60601-1-11 | Complies with IEC 60601-1-11 |
| EMC Compliance: Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Biocompatibility: Complies with ISO 10993-1, FDA Guidance | Complies with ISO 10993-1, FDA Guidance |
| Software Level of Concern: Moderate | Moderate |
| Labels & Labeling: Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements |
| Memory Size: Comparable to predicate (Up to 60x2 sets of data or Up to 99x2 sets) | 2x60 set of data |
| Operation Condition: Comparable to predicate (Temp +5~+40°C, Humidity 15%-90%RH, Air pressure 80.0kPa-105.0kPa) | Temperature +5~+40°C, Humidity $\leq$ 80%RH, Air pressure 80.0kPa-105.0kPa |
| Storage Condition: Comparable to predicate (Temp -20-+55 °C, Humidity 15%-90%RH, Air pressure Not publicly available) | Temperature -20-55 °C, Humidity 10%~90% RH, Air pressure 80.0kPa-105.0kPa |
| Power Supply: Comparable to predicate (4 AA batteries or 6V/600mA AC adapter) | 4 AA batteries or 5V/1.0A AC adapter |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 subjects.
- Data Provenance: The text states "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement." This indicates a prospective study. The country of origin is not explicitly stated, but the submission is from a Chinese company, so it is likely derived from China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth. It only mentions that "Auscultation was applied as gold standard" and "qualified calibrated mercurial sphygmomanometer used as control group." This implies a clinical setting where trained professionals would perform the auscultatory measurements, but specifics are missing.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that auscultation was used as the "gold standard."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance
This is an automated blood pressure monitor, not an AI-assisted diagnostic device that involves human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance study was done. The device itself (the "Automatic Digital Blood Pressure Monitor") is the algorithm-only component in terms of its measurement capability. The clinical trial directly assessed the accuracy of the device's measurements against a gold standard (auscultation), without intervention or interpretation by "human readers" in the typical sense of AI-assisted image analysis.
7. The Type of Ground Truth Used
The ground truth used was auscultation with a qualified calibrated mercurial sphygmomanometer. This is considered a direct physiological measurement by a trained operator, serving as the clinical gold standard for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The clinical trial described (150 subjects) is presented as the performance validation for the device's accuracy. For non-adaptive devices like this, there isn't typically a "training set" in the machine learning sense. The device's underlying measurement algorithm would have been developed and refined through engineering and calibration, not necessarily "trained" on a specific dataset in the way an AI model is.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, information on a specific "training set" and its ground truth establishment is not provided, as it's not directly applicable to the type of device described. The device's measurement principle (oscillometric method) and its calibration would be based on established physiological principles and engineering standards.
§ 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).