(144 days)
intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual who over the age of 12 in medical facilities or at home by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm).
The Subject device is not intended to be diagnostic device.
The device has four series : U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) , U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) and U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ).
All of them have same Indications for use and similar technological characteristics. All the models in the same series have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences between the four series are the appearance design, circuit diagram and the PCB layout. All of them have the same working principles, software design and the similar technical specification.
Urion Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The 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 Blood Pressure Monitor 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 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff.
The provided text describes the 510(k) submission for the Shenzhen Urion Technology Co., Ltd. Upper Arm Electronic Blood Pressure Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a typical study report detailing the achievement of specific acceptance criteria for an AI/ML device.
Therefore, the information required to fully answer your request regarding acceptance criteria and the study proving the device meets them (especially in the context of an AI/ML device, as implied by your detailed questions about MRMC studies, ground truth establishment, etc.) is largely absent from this particular FDA submission document.
This document primarily focuses on demonstrating the device's adherence to established standards for non-invasive blood pressure monitors, rather than the performance of an AI/ML algorithm with specific accuracy metrics derived from large datasets, expert labeling, and adjudication.
However, based on the provided text, I can infer and extract the relevant information for the clinical validation of this blood pressure monitor, which is a key part of its performance evaluation.
Here's the analysis of what is and isn't available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document references compliance with ISO 81060-2:2018+A1(2020) and IEC 80601-2-30:2018. These standards define the acceptance criteria for accuracy for non-invasive blood pressure monitors. While the explicit table of values isn't provided, the text states:
- Accuracy: Pressure: ±3mmHg; Pulse: ±5%
This is a general accuracy claim, and the clinical validation study is stated to have demonstrated that the Upper Arm Electronic Blood Pressure Monitor meets the requirements of these standards. The standards themselves would contain the specific statistical acceptance criteria (e.g., mean difference and standard deviation of differences between device and reference measurements within certain limits).
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 92 subjects were used for the clinical validation.
- Data Provenance: The document does not specify the country of origin. It implicitly describes a prospective clinical investigation ("This monitor is clinically investigated...").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not specified. For blood pressure clinical validation studies following ISO 81060-2, the "ground truth" (or reference measurements) is typically established by trained observers (often two) using auscultatory methods with a mercury sphygmomanometer or validated equivalent. The qualifications of these observers (e.g., specific training, certification) are crucial but not detailed in this summary.
4. Adjudication method for the test set
- Adjudication Method: Not explicitly stated. For ISO 81060-2 studies, commonly two observers simultaneously take measurements, and their readings are averaged or adjudicated if they differ significantly. The standard outlines specific procedures for this.
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
- MRMC Study: No. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic device that would involve human readers interpreting AI output. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the device's performance is inherently standalone. The clinical validation proves its accuracy as an automated non-invasive sphygmomanometer without human interpretation of its measurement results beyond reading the display. The "algorithm" here refers to the oscillometric method used by the device to determine BP and pulse.
7. The type of ground truth used
- Ground Truth Type: Clinical validation against reference blood pressure measurements (likely auscultatory method as per ISO 81060-2) and pulse rate from subjects. This is considered performance data directly from human subjects.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not explicitly mentioned. This is a traditional medical device, not an AI/ML device that requires a separate "training set" in the machine learning sense. Its internal "algorithm" (oscillometric method) is based on established physiological principles and signal processing, not on training data from a large dataset. The "development" and "testing" are primarily against engineering specifications and clinical validation standards.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. (See #8).
Summary of available information:
| Criterion/Information | Details from Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Acceptance Criteria (Implied by standards compliance): Defined by IEC 80601-2-30:2018 and ISO 81060-2:2018+A1(2020), which typically set limits on mean difference and standard deviation of differences between device and reference measurements. |
| Reported Performance: "Pressure: ±3mmHg; Pulse: ±5%". The study concludes the device "meets the requirement of IEC 80601-2-30:2018 and ISO 81060-2:2018+A1(2020)." | |
| 2. Test Set Sample Size & Data Provenance | Sample Size: 92 subjects |
| Data Provenance: Clinical investigation; appears prospective. Country of origin not specified. Ages over 12; at least 30% male, 30% female; included hypertensive patients; excluded pregnant women. | |
| 3. Experts for Ground Truth & Qualifications | Not specified (for blood pressure monitors, this typically involves trained clinical observers taking reference measurements, rather than "experts" establishing a diagnostic ground truth). |
| 4. Adjudication Method for Test Set | Not explicitly stated (standard methods for ISO 81060-2 typically involve multiple simultaneous observers and specific procedures for handling discrepancies). |
| 5. MRMC Comparative Effectiveness Study | No (not relevant for this type of device). |
| 6. Standalone Performance | Yes, the device's accuracy was clinically validated as a standalone automated non-invasive blood pressure monitor. |
| 7. Type of Ground Truth | Reference blood pressure and pulse rate measurements (likely auscultation by trained observers following ISO 81060-2 protocols). |
| 8. Training Set Sample Size | Not applicable (traditional medical device, not an AI/ML algorithm trained on a dataset). |
| 9. How Training Set Ground Truth Established | 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).