(93 days)
Truly Automatic Arm Blood Pressure Monitor, Models DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 are a series device 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 display a warning signal with the reading once the irregular heartbeat is detected. Over-The-Counter Use
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB33, DB81, DB83, DB85, DB91, DB92, DB93 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 subject devices are powered by four AA alkaline batteries. The device 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%.
Here's a breakdown of the acceptance criteria and study details for the Truly Automatic Arm Blood Pressure Monitor, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Values (ANSI/AAMI SP10 Standard) | Reported Device Performance (Test Result) – Systolic Pressure | Reported Device Performance (Test Result) – Diastolic Pressure |
|---|---|---|---|
| Mean difference between test device and reference method | ≤ 5 mmHg | 3.3 mmHg | 4.5 mmHg |
| Standard deviation of differences | ≤ 8 mmHg | 5.2 mmHg | 4.6 mmHg |
| Between-observer agreement: ≥ 95% of readings agree to within x 10 mmHg | 95% | 100% | 100% |
| Between-observer agreement: ≥ 85% of readings agree to within x 5 mmHg | 85% | 95% | 99% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 90 subjects.
- Data Provenance: The study was a clinical study conducted with subjects in a hospital setting. It includes 15 hypertensive patients, implying a mixture of normotensive and hypertensive individuals. The location (country) of the study is not explicitly stated, but the submitter is based in China. The study appears to be a prospective clinical study, as indicated by the "Subjects" and "Method" sections.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two doctors.
- Qualifications of Experts: Not explicitly stated beyond "doctors." However, given they were using a standard mercury sphygmomanometer and performing "simultaneous and blinded blood pressure determinations," it can be inferred they are trained medical professionals capable of accurately measuring blood pressure.
4. Adjudication Method for the Test Set
- The method described is "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies a form of independent double reading, where both doctors recorded their measurements without knowledge of the device's reading or each other's readings, and then these independent readings were compared against device readings and among themselves. It is not a typical 2+1 or 3+1 adjudication as seen in AI studies, but rather a direct comparison of independent expert measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This study focused on the accuracy of the device against a reference method and between human observers, not on how human readers' performance improved with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, this was effectively a standalone performance study. The device's measurements were compared directly against the reference standard (mercury sphygmomanometer readings by experts) and the agreement between experts themselves, without any human-in-the-loop interaction or AI assistance for the expert readings.
7. Type of Ground Truth Used
- Expert Consensus / Reference Standard: The ground truth for blood pressure measurements was established by two doctors using a "standard mercury sphygmomanometer" as a "reference standard." This represents an expert-determined reference standard, often considered the gold standard for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
- The document does not explicitly mention a separate "training set" or "training data" for the device's algorithm. For traditional medical devices like blood pressure monitors, the underlying oscillometric algorithm would typically be developed and validated during the device's design phase using various physiological models and potentially earlier clinical data, but this specific 510(k) summary focuses on the clinical validation of the final device rather than the algorithm's development.
9. How the Ground Truth for the Training Set Was Established
- As no training set is explicitly mentioned in this summary, the method for establishing its ground truth is also not provided. The information provided pertains solely to the clinical validation of the completed device.
§ 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).