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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:

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Measure blood pressure(systolic and diastolic) and pulse rate.

Upper Arm Electronic Blood Pressure Monitor, Model U86E and TelliBP01 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 wellknown technique in the market called the "oscillometric method".

The main components of the Upper Arm Electronic 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 22 cm to 42 cm, includes the inflatable bladder and fabric. The device consists of the main unit and cuff.

The product is provided non-sterile, and not to be sterilized by the user prior to use.

Model U86E and TelliBP01 in this submission follow the similar software, same measurement principle and similar specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device.

The model U86E embed an Bluetooth Wireless network connections module that allows it to send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments. The TelliBP01 embed a SIM card, which can send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments through 4G network. The wireless functions of U86E and TelliBP01 only have data transmission function, without any control feature.

Here's an analysis of the acceptance criteria and study details for the Upper Arm Electronic Blood Pressure Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical study for the device refers to "Criterion 1" and "Criterion 2" of ISO 81060-2:2018/A1:2020. This indicates that these are the acceptance criteria. The ISO 81060-2 standard defines accuracy requirements for automated sphygmomanometers. Based on the document, the requirements for clinical validation are as follows:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 93 qualified participants.
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical accuracy testing" and the language used in the document is English, but it's for a Chinese manufacturer. The study is prospective, as it's a "clinical study" performed for the purpose of validating the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated. The document mentions "A Mercury Sphygmomanometer was used as a reference device" which implies human observers for the reference measurements.
• Qualifications of Experts: Not explicitly stated. For a clinical validation of blood pressure devices using a mercury sphygmomanometer, it is generally understood that trained medical professionals or observers are required to take the reference readings and usually two observers are used for comparison, but the document does not specify their roles or qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For clinical validation of blood pressure monitors, if multiple observers are used for the reference method (e.g., auscultatory method with mercury sphygmomanometer), their readings would typically be averaged or adjudicated if they differ significantly. However, the document only mentions "A Mercury Sphygmomanometer was used as a reference device," which doesn't detail the number of observers or any adjudication process.

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 MRMC study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance study was done. The clinical testing performed according to ISO 81060-2:2018/A1:2020 evaluates the accuracy of the automated device (algorithm only) against a reference standard (mercury sphygmomanometer). The device is designed to provide readings automatically without human-in-the-loop interpretation once the measurement is initiated.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus via a reference device (Mercury Sphygmomanometer). The document states: "A Mercury Sphygmomanometer was used as a reference device." This is standard clinical practice for validating automated blood pressure monitors.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not provided in the document. The document describes clinical validation testing, which is separate from the training of the device's algorithms. The "oscillometric method" is a well-known technique, implying the core algorithm is established, but details of its training data (if any specific to this model's algorithm rather than general knowledge) are not included.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not provided. As stated above, the document focuses on the clinical validation of the device, not the development or training of its internal algorithms. The "oscillometric method" is a fundamental principle, and any specific training data and its ground truth establishment for this device's implementation of that method are not discussed.

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The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.

The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person 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 measurement principle and same specifications. The main differences are appearance, data storage and time display. These three differences will not affect the safety and effectiveness of the device.

The provided text describes a 510(k) premarket notification for a medical device, the "Upper Arm Electronic Blood Pressure Monitor U80 Series." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the document does not contain the detailed information typically associated with a study proving that a device meets specific acceptance criteria for AI/ML performance (e.g., number of experts, adjudication methods, MRMC studies, ground truth establishment for AI training/test sets). Instead, it relies on bench testing and comparison to an existing device.

Here's an analysis based on the available information and an explanation of why certain information requested is not present:

Context: The device is a non-invasive blood pressure monitor. The "acceptance criteria" discussed here are primarily related to meeting recognized performance standards for blood pressure measurement and demonstrating equivalence to a predicate device, not necessarily AI/ML performance criteria.

1. A table of acceptance criteria and the reported device performance

The document presents a "Substantially Equivalent Comparison" table (Table III-1) which serves as the primary way the device's performance is compared against regulatory and predicate device benchmarks. The "acceptance criteria" are implicitly defined by the predicate device's performance and relevant standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on bench tests and compliance with recognized standards for its performance evaluation, rather than a clinical "test set" in the context of AI/ML validation involving patient data.

The standards cited include:

• ANSI/AAMI/IEC 80601-2-30:2009 "Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers."
• ANSI/AAMI/ISO 81060-2:2009 "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

These standards outline clinical testing requirements, including sample sizes for validation studies for blood pressure monitors. For instance, ISO 81060-2 typically requires a certain number of subjects (e.g., usually around 85 subjects with specific age and BP distribution) for clinical validation. However, the specific sample size used in the company's validation study or its provenance for this specific submission is not explicitly detailed in the provided 510(k) summary. It is stated that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards." This implies the tests mandated by these standards were performed, but the summary does not include the raw results or the clinical trial specifics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not present in the document. The device is a blood pressure monitor, not an AI/ML diagnostic imaging device that requires radiologist interpretations for ground truth. The "ground truth" for a blood pressure monitor is established through a reference measurement method (e.g., auscultation by trained observers with mercury sphygmomanometers) as per the mentioned ISO/AAMI standards. The document does not detail the specifics of such clinical validation for this particular submission, only that the device "complies" with the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as it pertains to expert consensus on diagnostic images, not a standard blood pressure measurement device.

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 information is not applicable. This question refers to AI-assisted diagnostic tools. The device is an automated blood pressure monitor; there are no "human readers" interpreting its output that would be assisted by AI in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" automated blood pressure monitor in that it measures blood pressure directly via an oscillometric technique. Its performance is evaluated purely on its ability to accurately measure BP, as detailed by the standards it claims compliance with (e.g., accuracy of ±3 mmHg). There isn't an "algorithm only" component separate from the integrated device for this type of product that would typically necessitate such a study as posed in the context of complex AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood pressure monitors, the "ground truth" for clinical validation is typically established through simultaneous auscultatory measurements performed by trained human observers using a validated reference method (e.g., mercury sphygmomanometer or another agreed-upon reference device), following the protocols outlined in standards like ANSI/AAMI/ISO 81060-2. The exact specifics of how this ground truth was established for this specific device's compliance are not detailed in the provided 510(k) summary, beyond stating compliance with the standard that mandates such methods.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that undergoes training on a large dataset in the way a deep learning model would. Its "training" or development process would involve traditional engineering and calibration.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

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