(269 days)
The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm22cm, 22cm32cm, 32cm~42cm.
The subject device is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and the pulse rate of adult at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. All the models included in this submission follow the same software, same measurement principle and same specifications. The WBP100 does not have LCD display but has Bluetooth; WBP201 does not have Bluetooth but has LCD display, and WBP202 has LCD display and Bluetooth. The difference will not affect the safety and effectiveness of the subject device.
This document describes a 510(k) submission for an Electronic Sphygmomanometer (Model: WBP100, WBP201, WBP202) by Guangdong Biolight Meditech Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K131558).
Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states that the clinical study was conducted to evaluate if the device meets the accuracy requirements of ISO 81060-2:2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
While the document references this standard as the acceptance criterion, it does not provide a table of the specific numerical acceptance criteria (e.g., mean difference, standard deviation) from ISO 81060-2:2013, nor does it present the reported device performance with those specific numbers. It only states that the device "meets the accuracy requirements."
To fully answer this question, one would need to refer to ISO 81060-2:2013 to determine its specific accuracy criteria and then examine the full clinical study report (which is not provided in this excerpt) for the device's measured performance against those criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions a "clinical study" but does not explicitly state the sample size used for the test set (i.e., the number of subjects enrolled in the clinical validation). ISO 81060-2:2013 typically specifies minimum sample sizes for clinical validation (e.g., usually 85 subjects for Phase 1 and Phase 2 combined, or similar, depending on the specific method).
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for medical devices are typically prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For non-invasive blood pressure monitors, the "ground truth" for blood pressure measurements in a clinical validation study typically involves simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer, often with a "double stethoscope" setup to ensure independent readings.
The document does not specify the number of experts (observers) used or their qualifications (e.g., "trained observers" or "physicians with X years of experience"). ISO 81060-2:2013 outlines detailed requirements for the training and procedures for these observers to ensure accurate reference measurements.
4. Adjudication method for the test set:
In the context of blood pressure validation studies, "adjudication" usually refers to managing discrepancies between simultaneous reference measurements (e.g., if two observers get slightly different readings). ISO 81060-2:2013 specifies procedures for this, often involving taking the average of the two observer readings if they are within a certain range, or a third observer if they are too disparate.
The document does not explicitly state the adjudication method used for the test set, but it would have followed the methodology defined in ISO 81060-2:2013.
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:
This device is an Electronic Sphygmomanometer, a direct measurement device, not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study is not applicable to this type of device, and the concept of "human readers improving with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is an automated non-invasive sphygmomanometer. Its operation is inherently "standalone" in the sense that the device's algorithm performs the measurement and calculation of blood pressure without human intervention during the measurement process. The clinical validation outlined by ISO 81060-2:2013 evaluates this automated performance against reference measurements. So, the clinical study is effectively a standalone performance assessment of the automated device.
7. The type of ground truth used:
The ground truth for non-invasive blood pressure measurement devices validated against ISO 81060-2:2013 is typically established by simultaneous, direct auscultatory measurements performed by trained human observers using a calibrated reference device (e.g., mercury sphygmomanometer). This is considered the "gold standard" for clinical validation of these devices. It is not pathology or outcomes data.
8. The sample size for the training set:
This device is a hardware product with a measurement algorithm, not a machine learning model that requires a "training set" in the conventional sense of AI development. The "algorithm" here refers to the oscillometric method's logic and the device's internal programming for calculating BP. Therefore, the concept of a separate "training set" for an AI model does not apply to this medical device submission as described.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" and establishing ground truth for it does not apply in the context of this traditional medical device validation. The "ground truth" is relevant for the clinical validation (test set) to ensure the accuracy of the device's measurements against accepted reference methods.
§ 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).