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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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Upper Arm Electronic Blood Pressure Monitor, Models FC-BP103, FC-BP106,FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131 are 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 irreqular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.

The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than the measurement values. The unit also calculates an average reading based on the values of the latest 3 times measurement.

This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.

This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.

The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.

The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP121 and FC-BP130 applied).

There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.

No operation for 2 minute the device will shut down automatically.

The device includes model FC-BP103, FC-BP106,FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131,they are same except the appearance.

The provided text describes a 510(k) summary for an Upper Arm Electronic Blood Pressure Monitor (K242721) and states that it is substantially equivalent to a previously cleared predicate device (K220113). The submission focuses on demonstrating this substantial equivalence rather than presenting an exhaustive de novo study of the device's performance against specific acceptance criteria.

However, based on the Performance Comparison table provided, we can infer the acceptance criteria for key performance aspects based on what the device is reported to comply with. The study's conclusion is that the device meets these criteria because it is substantially equivalent to a predicate device that has already demonstrated compliance.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:
   The document explicitly states: "No additional non-clinical testing was considered necessary to support substantial equivalence" and "additional testing was not considered necessary to support the substantial equivalence." This implies that no new independent test set was used for the K242721 submission in terms of clinical accuracy or performance beyond functional verification of changes. The predicate device (K220113) would have undergone such testing. The current submission relies on the established performance of the predicate. Data provenance for the predicate device's original testing is not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no independent clinical study with expert ground truth establishment for the test set was reported for this specific submission (K242721). The submission relies on the predicate device's (K220113) previous validation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, for the same reason as above.

4. 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. The device is an Upper Arm Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, implicitly. The performance data for the blood pressure monitor is based on its standalone accuracy against reference measurements, as would be required by standards like IEC 80601-2-30. The "algorithm" for blood pressure measurement (oscillometric method) is core to the device's standalone performance. The document explicitly states "no changes made to the measurement algorithm, pressure sensor, cuff design, or calibration method" from the predicate device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For blood pressure monitors, the "ground truth" (or reference standard) in performance testing typically involves simultaneous measurements by trained observers using a validated auscultatory method (e.g., mercurial sphygmomanometer) as per standards like IEC 80601-2-30 or ISO 81060-2. This document references compliance with IEC 80601-2-30, implying that this standard's requirements for reference measurements were used in the predicate device's validation.

7. The sample size for the training set:
   Not applicable. This device is a medical measurement instrument, not an AI/ML device that requires a training set in the conventional sense. The "algorithm" refers to the oscillometric measurement method, which is a deterministic, established physiological principle, not a learned model.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this type of device.

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Upper Arm Electronic Blood Pressure Monitor is intended for used by a person older than twelve (12) years to measure the systolic and diastolic blood pressure and pulse rate.

The Upper Arm Electronic Blood Pressure Monitor uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a " zero pressure" equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsation , which is used to determine the systolic and diastolic pressure, and also pulse rate.

This document is a 510(k) summary for an Upper Arm Electronic Blood Pressure Monitor, aiming to demonstrate its substantial equivalence to a legally marketed predicate device. The information provided outlines the device's technical characteristics and the performance data submitted to support its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Key Acceptance Criteria and Reported Device Performance:

The primary performance criterion for a blood pressure monitor is its accuracy. The document states:

Study Details:

The clinical validation was conducted according to ISO 81060-2:2018+A1:2020 Non-invasive sphygmomanometers - Part 2: Clinical validation of intermittent automated measurement type.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Two clinical studies were performed. One study had 87 qualified subjects, and the other had 86 qualified subjects. The total combined sample size for the clinical test set is 173 (87 + 86).
   • Data Provenance: The document does not explicitly state the country of origin for the data. It also does not specify if the studies were retrospective or prospective, but clinical validation studies for device clearance are typically prospective.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • The document describes "Clinical validation," which for blood pressure monitors typically involves comparison against a reference standard (e.g., auscultatory measurements by trained observers using a mercury sphygmomanometer). However, the document does not explicitly state the number of experts or their qualifications (e.g., physicians, nurses, or specific training) used for establishing the ground truth. It states "all data's mean error and standard deviation of differences in systolic, diastolic pressure is not beyond the limits set as per ISO 81060-2:2020," implying the ground truth was established following the standard's methodology.

3. Adjudication Method for the Test Set:

   • The document does not explicitly describe an adjudication method for the test set, such as 2+1 or 3+1. For blood pressure clinical validation, the ISO standard typically outlines a procedure for simultaneous measurements by multiple observers which inherently acts as a form of "adjudication" by seeking agreement or averaging.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with AI vs. without AI assistance) is relevant for diagnostic imaging devices where AI assists human interpretation. For a standalone measurement device like a blood pressure monitor, the performance is evaluated against a clinical standard, not human-AI collaboration.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, a standalone performance evaluation was done. The entire clinical study described is a standalone evaluation of the device's accuracy in measuring blood pressure and pulse rate, independent of human interpretation assistance during the measurement process. The device's output (SYS, DYS, Pulse Rate) is the direct result of its algorithm and sensors.

6. Type of Ground Truth Used:

   • The ground truth type is directly tied to the ISO 81060-2:2018+A1:2020 standard. This standard typically defines the ground truth as reference blood pressure measurements obtained by trained independent observers using a validated reference method (e.g., auscultation with a manometer), against which the automated device's readings are compared. It's a type of "expert consensus/reference measurement" ground truth.

7. Sample Size for the Training Set:

   • The document does not provide information on the sample size used for the training set. For blood pressure monitors, the "training" (algorithm development) often happens with internal datasets or generalized physiological models, and the "test set" from clinical trials is for validation.

8. How the Ground Truth for the Training Set Was Established:

   • As with the training set size, the document does not provide details on how the ground truth for an internal training set (if any specific to the algorithm's learning) was established. Assuming the device relies on established oscillometric principles and calibration, the "training" may refer more to engineering and calibration rather than a machine learning training dataset with labeled ground truth in the same sense as an AI diagnostic device.

Additional Performance Data:

Beyond clinical accuracy, the document lists several other performance data types provided:

• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation.
• Electrical Safety, EMC, Performance testing: Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-2, IEC 80601-2-30, and IEC 80369-5.
• Wireless testing: Compliance with ANSI C63.27-2021, AAMI TIR69:2020, FDA guidance, and FCC Part 15 Subpart C for its wireless module (Bluetooth and 4G for A01/A02 series respectively).
• Cybersecurity: Addressed according to relevant FDA guidance.
• Shelf-life: Evaluated for 5 years.
• Reprocessing: Information provided per ISO 17664.

In summary, the provided document focuses primarily on the clinical validation of blood pressure accuracy and other critical engineering aspects against recognized international standards. It clearly indicates that the device met the accuracy requirements set by ISO 81060-2:2020. However, specific details often found in AI/imaging device submissions regarding expert adjudication, multi-reader studies, and detailed training data provenance are not as prominent, as they are less relevant for this type of medical device.

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Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are 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 includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP100 and FC-BP110 applied). There is a maximum pressure safety setting at 300 mmHq, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 1 minute the device will shut down automatically. The device includes model FC-BP100.FC-BP101.FC-BP102.FC-BP110. FC-BP111. FC-BP112,they are same except the appearance.

The provided text describes the clinical validation study for the Upper Arm Electronic Blood Pressure Monitor (Models FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly mentions "The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg." This refers to blood pressure accuracy. While the Table 2 Performance Comparison lists "Pulse Accuracy: ±5% of reading value" as a specification for both the subject and predicate devices, it does not explicitly state that this was an acceptance criterion for the clinical validation or that the clinical study results confirmed this specific numerical accuracy for pulse rate. However, compliance with ISO 81060-2:2018 generally covers both BP and pulse rate accuracy indirectly through its clinical validation methodology for automated sphygmomanometers.

2. Sample Size and Data Provenance

• Sample Size (Test Set): 138 subjects
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was a prospective clinical trial, as "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement."

3. Number of Experts and Qualifications

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions:

• "Auscultation applied as gold standard"
• "qualified calibrated mercurial sphygmomanometer used as control group"

This implies that trained clinical personnel (likely physicians or nurses experienced in blood pressure measurement via auscultation) were involved in generating the ground truth.

4. Adjudication Method

The document does not specify an adjudication method like 2+1 or 3+1. The use of "Auscultation applied as gold standard" with a "qualified calibrated mercurial sphygmomanometer" suggests that the auscultation readings themselves were considered the definitive ground truth, potentially implying readings taken by at least two observers per subject to ensure accuracy, though this is not explicitly detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the standalone performance of the device against a gold standard, not on how human readers' performance improved with or without AI assistance.

6. Standalone Performance

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The clinical trial directly evaluated the device's accuracy in measuring blood pressure against the auscultation gold standard.

7. Type of Ground Truth Used

• Expert Consensus / Reference Method: The ground truth was established by auscultation using a "qualified calibrated mercurial sphygmomanometer." This is considered a clinical reference method, often performed by trained experts.

8. Sample Size for the Training Set

• The document does not mention a separate training set or its sample size. The description of the clinical trial refers to the validation of the device's performance after its development.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as a separate training set and its ground truth establishment method are not described in the provided text. The clinical trial described is for validation of the device's performance.

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Upper Arm Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

The Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN operation is based on the oscillometric method. This method takes advantage of the pressure pulsations taken during measurements. An occluding cuff is placed on the left arm and is connected to an air pump and a pressure sensor. The cuff is inflated until a pressure higher than the typical systolic value is reached, then the cuff is slowly deflated. As the cuff deflates, when systolic pressure value approaches, pulsations start to appear. These pulsations represent the pressure changes due to heart ventricle contraction and can be used to calculate the heartbeat rate. Pulsations grow in amplitude until mean arterial pressure (MAP) is reached, then decrease until they disappear. The blood pressure information is displayed as digital information on the device's screen.

The provided text is related to a 510(k) premarket notification for an Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN. The document describes the device, compares it to a predicate device, and outlines the testing conducted to support its substantial equivalence.

However, the request asks for specific details about acceptance criteria and a study that proves the device meets the acceptance criteria, particularly in the context of an AI/ML medical device. The provided document is for a traditional medical device (blood pressure monitor) and does not contain information about AI/ML acceptance criteria or an AI-based study. It focuses on performance standards (like IEC 80601-2-30) for blood pressure measurement accuracy, not AI performance metrics.

Therefore, I cannot fulfill the request as it asks for information (AI acceptance criteria, AI study details, expert ground truth, MRMC study, etc.) that is not present in the provided document. The document describes non-clinical and performance testing for a standard blood pressure monitor.

To directly answer the prompt and explain why I cannot provide the requested information, here's a breakdown of what is and is not in the text:

Information Present in the Document:

• Device Name: Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN
• Predicate Device: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE670D (K170605)
• Indication for Use: Measuring blood pressure and pulse rate of adults at household or medical center (not for neonate, pregnancy, or pre-eclampsia).
• Measurement Method: Non-invasive, oscillometric.
• Performance Standards Met: IEC 80601-2-30 (Medical electrical equipment Part 2-30: Particular Performance requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) and ISO 81060-2 (Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type).
• Accuracy Claims (from characteristics table): Blood Pressure Range Accuracy: ±3 mmHg (±0.4kPa); Pulse Rate Measurement Accuracy: ±5% of reading value.
• Non-Clinical Testing: Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11), Software Verification and Validation (following FDA Guidance for moderate level of concern software), Cleaning Validation, Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10).
• Clinical Study: "a comparative clinical study to verify the performance of the subject device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2:2013." This is a study to validate the accuracy of the blood pressure readings against a reference, not an AI performance study.

Information Not Present in the Document (and thus, cannot be provided to answer your specific questions about AI/ML acceptance criteria and studies):

• Table of AI acceptance criteria and reported device performance: The document lists performance criteria for a blood pressure monitor (e.g., accuracy ±3 mmHg) but not AI-specific metrics like sensitivity, specificity, AUC, F1-score, etc.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): While a "comparative clinical study" is mentioned, no details about sample size (number of subjects), data provenance, or whether it was retrospective/prospective are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is for a blood pressure monitor, not an AI image interpretation device. Ground truth for blood pressure is typically established by direct measurement with a reference standard (like a mercury sphygmomanometer) in a clinical setting.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable for this device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical measurement device, not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure, the ground truth is often the reading from a validated reference device (e.g., mercury sphygmomanometer) or invasive arterial pressure. The document mentions comparison to a mercury sphygmomanometer.
• The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set in that context.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) clearance document is for a basic medical device (blood pressure monitor) and does not describe an AI/ML device or its associated acceptance criteria and validation studies as detailed in your query.

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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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