(197 days)
The Blood Pressure Monitor CBP111/CBP112 is intended for non-invasive measuring of an adult individual's systolic, diastolic blood pressure and heart rate in home or clinical use. Blood pressure readings should be taken on the upper arm of an adult only, and the suitable cuff size is from 22cm to 32cm.
Blood Pressure Monitor CBP111/CBP112 is a non-invasive blood pressure measurement system for use in hospital, at home or clinical use. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the digital readings on LED screen. Blood pressure readings should be taken on the upper arm of an adult only. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading on LED screen. The proposed device CBP111/CBP112 has the following components: power supply management module, blood pressure data acquisition module, MCU and peripheral, data communication module, data storage module, pump value plate controlling module and program debugging and burning module. The Blood Pressure Monitor CBP111 and CBP112 have the same electrical circuit and structure design. They have the same accessories. They also have the same display type, control module and communication module. The difference between them is the measurement type. The CBP111 is reading the data while it is deflating. The CBP112 is reading the data while it is inflating. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over the counter use. The device does not contain drug or biological products. The device is software-driven and software validation is provided in software.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the Blood Pressure Monitor CBP111/CBP112:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device was tested for clinical accuracy in accordance with ISO 81060-2:2013, which specifies acceptance criteria for non-invasive sphygmomanometers. While the exact numerical acceptance criteria from ISO 81060-2:2013 are not explicitly listed in this summary, the document does state the device's accuracy specifications, which can be interpreted as the target performance criteria it aims to meet.
| Characteristic | Acceptance Criteria (likely from ISO 81060-2:2013) | Reported Device Performance (CBP111/CBP112) |
|---|---|---|
| Blood Pressure Measurement Accuracy | Mean absolute difference $\le$ 5 mmHg, std dev $\le$ 8 mmHg (ISO 81060-2:2013) * | ± 3mmHg |
| Pulse Rate Measurement Accuracy | (Not explicitly stated in this document, but implied by standards) | >60bpm ± 5%, $\le$ 60bpm, ± 3bpm |
Note: The specific numerical acceptance criteria from ISO 81060-2:2013 for blood pressure accuracy (mean difference and standard deviation) are standard for clinical validation. The document states a general "± 3mmHg" which the device aims to meet. A clinical study that passes ISO 81060-2:2013 would inherently mean it met the statistical criteria of that standard.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: 85 patients (42 females and 43 males)
- Data Provenance: Not explicitly stated, but clinical studies for medical devices are often conducted in controlled clinical environments or hospitals. The general context of a 510(k) submission suggests that this would be a prospective study designed specifically for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- The document states that "Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm." This implies that the ground truth was established by human operators using the auscultatory method, which is considered the gold standard for non-invasive blood pressure measurement.
- Number of Experts: Not explicitly stated how many operators performed the auscultation.
- Qualifications of Experts: Not explicitly stated, but for a clinical study comparing to the auscultatory method, the operators would typically be trained healthcare professionals (e.g., physicians, nurses, or trained technicians) experienced in taking manual blood pressure measurements.
4. Adjudication Method for the Test Set:
- No specific adjudication method is described. The comparison was directly between the device's readings and the "standard auscultation method." In such studies, the auscultation readings are generally considered the definitive ground truth against which the automated device is compared.
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 MRMC comparative effectiveness study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, a standalone study was performed. The "Clinical Test Summary" describes the evaluation of the device's accuracy by comparing its measurements directly against the auscultation method. This evaluates the algorithm's performance without human interpretation of the device's output.
7. The Type of Ground Truth Used:
- Expert Consensus (Auscultation): The ground truth was established through the "standard auscultation method," which relies on the trained ear and skill of a human operator to identify Korotkoff sounds, widely considered the clinical gold standard for non-invasive blood pressure.
8. The Sample Size for the Training Set:
- The document does not mention a separate "training set" or a sample size for it. For a traditional medical device like a blood pressure monitor, the algorithm (oscillometric method) is typically well-established and validated rather than "trained" on a custom dataset in the way a modern AI deep learning model would be. Calibration and optimization would occur during the device's development phase, but not in the context of a "training set" as understood in current AI development. The 85 patients described are for the validation or test set.
9. How the Ground Truth for the Training Set Was Established:
- As a separate training set is not explicitly mentioned for algorithm development in the provided summary, there is no information on how its ground truth would have been established. The core oscillometric principle is a well-understood physical phenomenon rather than a learned model from a dataset.
§ 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).