(113 days)
The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
The Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed AOJ-30A and AOJ-30B Electronic Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The main differences are product appearance. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use.
The provided text describes the acceptance criteria and the study conducted for the Electronic Blood Pressure Monitor models AOJ-30A and AOJ-30B.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Accuracy (Static Pressure) (ISO 80601-2-30:2009 & 81060-2:2013) | ± 3 mmHg |
| Accuracy (Pulse) (ISO 80601-2-30:2009 & 81060-2:2013) | ± 5% |
| Electrical Safety (IEC 60601-1: 2012) | Complies |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2: 2014) | Complies |
| Home Healthcare Environment Requirements (IEC 60601-1-11: 2010) | Complies |
| Biocompatibility (ISO 10993-1) | Cytotoxicity, Skin Sensitization, Skin Irritation tests passed |
| "Major" Level of Concern Software (FDA Guidance for Software in Medical Devices) | Software verification and validation testing conducted and documentation provided. |
Study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is a combination of non-clinical and clinical performance testing, as detailed in section 8 of the 510(k) Summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." However, the specific sample size used for the clinical test set is not provided in the document. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated, although the submitter is based in Shenzhen, China.
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)
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by comparing the device's readings to reference measurements taken by trained professionals using a validated method (e.g., auscultation with a mercury sphygmomanometer). The number and qualifications of these professionals are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for establishing ground truth in the clinical testing.
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 is an "Electronic Blood Pressure Monitor" and measures physiological parameters directly. It is not an AI-assisted diagnostic device that would involve human readers or image interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary evaluation of this device is standalone (algorithm only) performance, as it is an automated blood pressure monitor. The clinical validation per ISO 81060-2:2013 evaluates the device's accuracy in measuring blood pressure values directly, without human intervention in the measurement process itself, beyond proper cuff placement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical validation of automated non-invasive sphygmomanometers (as per ISO 81060-2:2013), the ground truth for blood pressure measurements is typically established by simultaneous measurements by trained observers using a reference method, often auscultation with a mercury sphygmomanometer, under specific protocols. This would fall under a form of "expert consensus/reference measurement."
8. The sample size for the training set
The document does not mention a training set sample size. For medical devices that rely on algorithms, training data is often used internally during development. However, the 510(k) submission focuses on the validation of the final product.
9. How the ground truth for the training set was established
Since a training set is not explicitly discussed, the method for establishing its ground truth is not provided in the document. If an algorithm was trained, it would likely use similar methods to the clinical validation for establishing ground truth, i.e., comparison to reference measurements.
§ 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).