(261 days)
The Wrist Digital Blood Pressure Monitor (Model: BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor intended to measure the diastolic, systolic blood pressure and pulse rate in adult with an inflatable wrist cuff circumference ranging from 13.5 to 19.5cm. It is intended for clinical and home use.
The Wrist Digital Blood Pressure Monitor (Model: BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a digital and non-invasive monitor that uses the cuff oscillometric method to measure diastolic and systolic blood pressure and pulse rate. It has an LCD digital display, is powered by two "AAA" batteries, and uses automatic inflation with an electric pump and automatic rapid deflation valve.
The provided text describes the 510(k) submission for a Wrist Digital Blood Pressure Monitor. I will extract the information requested regarding acceptance criteria and the study that proves the device meets them.
Acceptance Criteria and Device Performance
A digital blood pressure monitor's primary acceptance criteria are its accuracy in measuring blood pressure and pulse rate. The relevant standard cited is ISO 81060-2: 2018 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type) for clinical performance, and specific accuracy values are mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Blood Pressure | Within ±3mmHg | "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018." - This implies meeting the ±3mmHg criterion, as that is the standard for blood pressure accuracy in ISO 81060-2:2018. |
| Pulse Rate | Within ±5 % of reading | Not explicitly stated as a separate result, but implied to be met through ISO 81060-2:2018 compliance, which validates both BP and PR. |
| Cuff Pressure Range | 0 to 295mmHg (Proposed Device) | Passed the test of ISO 80601-2-30. |
| Operating Temp. | 5 to 40 °C (41 to 104 °F) (Proposed Device) | Passed IEC 60601-1-11 & IEC 80601-2-30 standards. |
| Storage Temp. | -20 to 55 °C (-4 to 131 °F) (Proposed Device) | Passed IEC 60601-1-11 & IEC 80601-2-30 standards. |
| Electrical Safety | According to IEC 60601-1-11 and IEC 80601-2-30 standards | Passed. |
| EMC | According to IEC 60601-1-2 standard | Passed. |
| Biocompatibility | According to ISO 10993-5 and ISO 10993-10 standards | Passed. |
| Software Validation | According to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Passed. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Enrolled: 130 subjects
- Selected (met inclusion requirements): 85 subjects (44 males and 41 females)
- Data Provenance: The document does not explicitly state the country of origin. It describes a "validation study" which implies a prospective clinical study rather than retrospective. The study was conducted as part of the regulatory submission process for a device from Shenzhen, China, suggesting the study might have been conducted there or in a region that supports compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth for this device, nor does it mention experts in the context of ground truth for a blood pressure monitor. For blood pressure devices, ground truth is typically established by simultaneous readings from a reference manometer (mercury sphygmomanometer) as per ISO standards, not expert readers.
4. Adjudication method for the test set
The document does not describe any adjudication method. For blood pressure monitor validation studies by ISO 81060-2, adjudication by multiple readers is not typically part of the ground truth establishment process in the same way it would be for image interpretation tasks. The standard relies on simultaneous measurements by trained personnel using reference devices.
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 or is applicable here. This document pertains to a digital blood pressure monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that human readers would interact with.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was performed. The device itself, which performs blood pressure and pulse rate measurements using an algorithm, was clinically validated against a ground truth (established by trained observers using a reference method as per ISO 81060-2) without human intervention in the device's measurement process.
7. The type of ground truth used
The ground truth used was based on clinical validation as per ISO 81060-2: 2018. This standard specifies that simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer (or an equivalent reference standard) serve as the ground truth. The document states: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018." This directly refers to the comparison of the device's readings against this established ground truth.
8. The sample size for the training set
The document does not mention a training set or any machine learning/AI training process. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-based device that would require a separate training set.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/ML model, this question is not applicable.
§ 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).