(216 days)
The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
The proposed device, Arm Blood Pressure Monitor, is an automatic noninvasive Blood Pressure Monitor which can be driven by dry batteries. 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, not for neonate or pregnancy.
The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.
This blood pressure monitor has the memory function of 60 groups of measuring data of two people, 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 according to the World Health Organization/ International Society for hypertension(WHO/ISH) guidelines on the treatment of hypertension dated in 1999.
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 Arm Blood Pressure Monitor is M5303(small adult)/M5304(adult)/ M5305(big 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 information provided primarily describes a 510(k) submission for an Arm Blood Pressure Monitor (model RN-032A, RN-032C), indicating its substantial equivalence to a predicate device. The document mentions a clinical trial conducted to prove its performance.
Based on the provided text, here's what can be extracted regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the device's accuracy are based on a specific standard: ISO 81060-2:2018.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy (Systolic & Diastolic) | Meets the requirements of ISO 81060-2:2018; achieved results within ±3mmHg of the gold standard. |
| Pulse Rate Accuracy | Not explicitly stated an acceptance criterion, but the general performance comparison table indicates ±5% of reading value for pulse accuracy. No specific clinical trial result for pulse rate accuracy is provided beyond meeting the standard. |
2. Sample size used for the test set and the data provenance
- Sample Size: 150 subjects.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical trial for device validation, it is generally assumed to be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that "Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group". It does not specify the number or qualifications of the individuals performing the auscultation. For blood pressure measurement studies, the "experts" are typically trained operators using a standardized auscultation method.
4. Adjudication method for the test set
The document does not describe an adjudication method. For blood pressure studies using auscultation, there isn't typically an adjudication process in the same way there would be for image-based diagnostics. The auscultatory readings from the trained operators serve as the "gold standard" for comparison.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is specifically relevant for AI-assisted diagnostic tools where human interpretation of images or data is a key component. This device is an automated blood pressure monitor, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the loop performance) was done
- Standalone Performance: Yes, in essence, the clinical trial described assesses the standalone performance of the automated blood pressure monitor. The device's measurements (algorithm's output) were compared directly against the gold standard (auscultation). The accuracy result of "within ±3mmHg" is the standalone performance.
7. The type of ground truth used
- Type of Ground Truth: Expert consensus (specifically, auscultation by trained individuals or a qualified operator) using a qualified calibrated mercurial sphygmomanometer. This is the established clinical method for accurate blood pressure measurement.
8. The sample size for the training set
The document does not provide information on a training set sample size. This is a clinical validation study for a medical device's performance, not a study for a machine learning model that would typically have distinct training and test sets. The "clinical trial" described is the performance validation (test set).
9. How the ground truth for the training set was established
Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this type of device validation study.
§ 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).