(147 days)
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study that proves the device meets them.
The document describes the submission of a "Truly Automatic Arm Blood Pressure Monitor" (Models DB66-1, DB68) for 510(k) clearance, asserting its substantial equivalence to a predicate device (DB62, K161846).
Acceptance Criteria and Reported Device Performance
The core acceptance criteria for a non-invasive blood pressure monitor are its accuracy for both pressure and pulse readings. The document refers to compliance with ISO 81060-2:2013, which sets the standards for clinical validation of automated sphygmomanometers.
Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (from ISO 81060-2:2013, implied) | Reported Device Performance (from "Table-2: The comparison table in Design and Materials") |
|---|---|---|
| Accuracy Pressure | Mean difference $\le \pm 5$ mmHg and standard deviation $\le 8$ mmHg (for both systolic and diastolic blood pressure) | ± 3mmHg (This is directly stated as "Accuracy Pressure" for the device, which is well within the ISO standard's requirements for mean difference, and implies the device meets the deviation as well, as confirmed by the clinical study summary.) |
| Accuracy Pulse | ± 5% | ± 5% |
| Measurement Pressure Range | 20 ~ 280 mmHg | 20 ~ 280 mmHg |
| Measurement Pulse Range | 40 ~ 195 beats/min | 40 ~ 195 beats/min |
| Measurement Resolution | 1 mmHg | 1 mmHg |
Study Proving Device Meets Acceptance Criteria:
The document states:
"Testing Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device. Compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device."
This directly indicates that a clinical validation study, adhering to the ISO 81060-2 standard, was performed, and the device successfully met its requirements.
Detailed Information about the Study:
Given the provided text, some of the requested information is not explicitly detailed. However, based on common practice for ISO 81060-2 clinical validation studies for blood pressure monitors, we can infer some aspects and state what is present in the document.
1. A table of acceptance criteria and the reported device performance:
- See table above. The document explicitly states the device's accuracy for pressure (± 3mmHg) and pulse (± 5%), and confirms "the required limits for mean difference and standard deviation are fulfilled by the subject device" according to ISO 81060-2.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size. However, ISO 81060-2 typically requires a minimum of 85 subjects for clinical validation. It can be assumed that the study met this minimum requirement to claim compliance.
- Data Provenance (Country of origin, retrospective/prospective): The document does not explicitly state the country of origin or if the study was retrospective or prospective, but clinical validation studies for regulatory submission are almost invariably prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts. For oscillometric blood pressure devices validated against ISO 81060-2, ground truth (reference blood pressure) is established by two trained observers using a mercury or auscultatory sphygmomanometer following a specific protocol. These observers are trained to accurately read the reference device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not explicitly state the adjudication method. For ISO 81060-2, the ground truth is typically established by two independent observers taking simultaneous readings. If their readings differ by more than a specified amount, a third measurement (or a different method of reconciliation) might be employed, though two simultaneous, blinded observers are standard for the reference method.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools (e.g., radiology AI), not for a standalone non-invasive blood pressure monitor. The device is measuring a physiological parameter directly, not interpreting complex medical images for human assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, this was a standalone performance test. The clinical validation per ISO 81060-2 assesses the accuracy of the automated device (algorithm + hardware) against a reference standard (manual auscultatory method). While a human applies the cuff and initiates the measurement, the device's measurement process itself is automated ("algorithm only" in the context of its function).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by simultaneous auscultatory measurements performed by trained observers using a reference sphygmomanometer (typically mercury or validated aneroid) on the contralateral arm or simultaneously on the same arm if protocol allows, per ISO 81060-2. This is the "expert consensus" of blood pressure measurement via a gold standard clinical method.
8. The sample size for the training set:
- The document does not provide information on a training set sample size. For medical devices primarily validated through performance testing against an ISO standard (like blood pressure monitors), the term "training set" in the context of machine learning (AI development) isn't directly applicable in the same way. The device's underlying "oscillometric method" is a long-established algorithm, not typically a deep learning model requiring a large training dataset in the same vein as image classification AI. The development of the algorithm might involve internal data, but it's not described here.
9. How the ground truth for the training set was established:
- As noted above, the concept of a "training set" with ground truth in the AI sense isn't directly applicable or described for this traditional medical device. The "ground truth" for the validation (test set) study was established through the gold-standard auscultatory method by trained observers. If any internal algorithm refinement involved data, it would likely follow similar principles of comparison to expert-measured reference values.
§ 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).