(46 days)
The A&D LifeSource UB-328 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.
The A&D LifeSource UB-328 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. UB-328 uses an inflated cuff which is wrapped around the upper wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, UB-328 turns off automatically. UB-328 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
Here's a breakdown of the acceptance criteria and study information for the A&D LifeSource UB-328 Digital Blood Pressure Monitor, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to the AAMI SP-10 standard. The device's performance is reported as "Conformed" for all applicable sections of this standard. While the document lists sections of SP-10 that were tested, specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in this summary. Instead, a qualitative "Conformed" status is given for each test.
| SP-10 Section # | Section Title | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|---|
| 4.1.1 | General | (Standard requirements) | Conformed |
| 4.1.2.1 | Device labeling | (Standard requirements) | Conformed |
| 4.1.2.2 | Outer container | (Standard requirements) | Conformed |
| 4.1.3 | Information manual | (Standard requirements) | Conformed |
| 4.1.4.1 | Component replacement | (Standard requirements) | Conformed |
| 4.1.4.2 | Power system labeling | (Standard requirements) | Conformed |
| 4.1.4.3 | Labeling for battery-powered devices | (Standard requirements) | Conformed |
| 4.2.1 | Storage conditions | (Standard requirements) | Conformed |
| 4.2.2 | Operating conditions | (Standard requirements) | Conformed |
| 4.2.3 | Vibration and shock | (Standard requirements) | Conformed |
| 4.2.4.1 | Voltage range | (Standard requirements) | Conformed |
| 4.2.4.2 | Life | (Standard requirements) | Conformed |
| 4.3.1.1 | Maximum cuff pressure | (Standard requirements) | Conformed |
| 4.3.1.2 | Cuff deflation | (Standard requirements) | Conformed |
| 4.3.2 | Electrical safety | (Standard requirements) | Conformed |
| 4.3.3 | Conductive components | (Standard requirements) | Conformed |
| 4.4.1 | Pressure indicator accuracy | (Standard requirements) | Conformed |
| 4.4.2 | Overall system efficacy | (Standard requirements) | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard | (Standard requirements) | Conformed |
| 4.4.2.2 | Intra-arterial method as the reference standard | (Standard requirements) | Not applicable |
| 4.4.3 | Battery-powered devices | (Standard requirements) | Conformed |
| 4.5 | Requirements for devices with manual inflation systems | (Standard requirements) | Conformed |
Note: The AAMI SP-10 standard typically defines specific accuracy requirements for blood pressure monitors (e.g., mean difference and standard deviation between the device and a reference method). However, this 510(k) summary only states "Conformed" rather than providing the numerical results for these key performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that the device "meets NIST/AAMI SP-10 standard and FDA guidance 'Non-invasive Blood Pressure (NIBP) Monitor Guidance'." However, it explicitly states: "UB-328 is not clinically tested." This implies that the testing was based on laboratory and engineering evaluations rather than a clinical study with a human test set. Therefore, information regarding "sample size used for the test set," "country of origin of the data," and whether it was "retrospective or prospective" is not applicable as there was no disclosed human clinical test set.
The basis for equivalence is that the device "uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since the device was not clinically tested and relied on equivalence to predicate devices and adherence to engineering standards (AAMI SP-10), there is no mention of experts establishing ground truth for a clinical test set. The AAMI SP-10 standard itself would detail requirements for reference measurements, likely involving trained technicians for auscultatory methods in clinical trials, but these details are not provided here for this specific device's evaluation.
4. Adjudication Method for the Test Set
Not applicable, as no human clinical test set with adjudicated ground truth is described.
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
Not applicable. This device is a digital blood pressure monitor, not an AI-assisted diagnostic imaging device with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense. The testing performed was for the device itself (algorithm + hardware) to meet engineering and performance standards (AAMI SP-10) without human interpretation in a diagnostic context. The document confirms it "is not clinically tested," meaning it was evaluated as a standalone product adhering to technical standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the technical tests conducted according to AAMI SP-10 (e.g., pressure indicator accuracy, overall system efficacy using auscultatory method as reference), the implied ground truth would be:
- Engineering Reference Standards: For many of the technical sections (e.g., voltage range, storage conditions, cuff pressure).
- Auscultatory Method: Specifically mentioned as the "reference standard" for "Overall system efficacy" (Section 4.4.2.1), which is the standard clinical method for validating automated blood pressure devices.
8. The Sample Size for the Training Set
Not applicable. This device does not appear to use a machine learning or AI model that requires a "training set" in the typical sense. Its performance relies on fixed algorithms and hardware, which are compared against established standards.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a machine learning model or a training set.
§ 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).