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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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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia).

Electronic blood pressure monitor is a Noninvasive Blood Pressure Measurement System that is intended to measure blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record may be revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The electronic blood pressure monitor is small, portable and used in home or medical facilities environment. It consists of two parts: main unit and cuffs. The electronic blood pressure monitor is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

The provided text describes the acceptance criteria and the study that proves the device (Electronic Blood Pressure Monitor models D6606US, D6607US) meets these criteria, primarily by demonstrating substantial equivalence to a predicate device (HTD6602US, K223170).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international standards and are met by the device. The reported device performance is that it meets these standards.

2. Sample size used for the test set and the data provenance

The document states that a clinical study was performed on the predicate device (HTD6602US, K223170). The results of this study were transferred to the subject device (D6606US, D6607US) because the subject device has the same specifications, intended use, method of measurement, measurement type, critical components (e.g., air pump, sensor, cuff), and algorithm as the predicate device.

• Sample Size for Clinical Accuracy Testing: The document does not explicitly state the sample size. It only refers to "all the relevant activities were performed by designate individual(s)" as per ISO 81060-2. ISO 81060-2 specifies requirements for clinical investigation of automated non-invasive sphygmomanometers, which includes specific sample size requirements (e.g., typically at least 85 subjects with a distribution across blood pressure ranges). However, the exact number is not provided in this submission summary.
• Data Provenance: The clinical study data originates from the testing done for the predicate device K223170. The country of origin and whether it was retrospective or prospective are not specified in this document, but "clinical investigation" usually implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document mentions that for the clinical accuracy testing (performed on the predicate device), "all the relevant activities were performed by designate individual(s)". It does not specify the number of experts or their qualifications for establishing ground truth, but implicitly, highly qualified medical professionals/technicians are required to perform and verify measurements according to ISO 81060-2.

4. Adjudication method for the test set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For blood pressure measurement studies following ISO 81060-2, ground truth is typically established by trained observers (often two) using a reference sphygmomanometer, with specific protocols for resolving discrepancies, although these details are not provided here.

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: This device is an Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done as it is irrelevant for this type of device.

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

• Yes, a standalone performance assessment was done (implicitly). The primary study cited is the clinical accuracy testing of the predicate device against ISO 81060-2. This standard evaluates the accuracy of the automated device (algorithm only) compared to a reference measurement performed by trained observers, effectively assessing its standalone performance. The results of this standalone performance were deemed acceptable for the predicate and transferred to the subject device.

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

The ground truth for the clinical accuracy testing (following ISO 81060-2) is established by simultaneous or sequential measurements using a standardized reference method (e.g., mercury sphygmomanometer with trained observers) against which the automated device's readings are compared. This is a form of expert measurement/consensus in a controlled clinical setting.

8. The sample size for the training set

This information is not applicable/provided. The device is an Electronic Blood Pressure Monitor based on oscillometric measurement, not a machine learning or AI device that typically requires a "training set" in the conventional sense. The development of its algorithm would involve engineering and calibration, not statistical training on a dataset of labeled cases in the AI context.

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

This information is not applicable/provided for the same reasons as point 8.

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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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The 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.
The intended arm circumference includes 22 cm~32 cm.

The proposed device, Electronic Blood Pressure Monitor, is a battery driven non-invasive blood pressure monitor. It can complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHq or KPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed electronic blood pressure monitor has 13 models, including PG-800B30, PG-800B39, PG-800B45, PG-800B46, PG-800B48, PG-800B48, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided document is a 510(k) summary for an Electronic Blood Pressure Monitor (Model: PG-800B30, etc.) from Shenzhen Pango Medical Electronics Co., Ltd. This document does not contain information about software algorithms for intelligent analysis or AI assistance. Therefore, it does not provide the details requested for acceptance criteria and study proving device performance for such AI-based systems.

The document discusses the substantial equivalence of the new device to a predicate device (K170151), focusing on non-clinical tests (electrical safety, EMC, software verification/validation, human factors/usability) and stating that no clinical measurement performance test was needed because the blood pressure measurement function, principle, and NIBP algorithm are identical to the legally marketed predicate device.

Specifically, the document lacks the following:

• Acceptance criteria table and reported device performance for an AI/ML algorithm. The "Accuracy" row in the comparison table refers to the device's accuracy for blood pressure measurement (3mmHg), not an AI algorithm's performance metrics.
• Sample size and data provenance for an AI test set.
• Number of experts and their qualifications used for ground truth establishment for an AI algorithm.
• Adjudication method for an AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone (algorithm-only) performance data.
• Type of ground truth used for an AI algorithm.
• Training set sample size for an AI algorithm.
• Method for establishing ground truth for an AI training set.

The document states that the device's software was considered a "Moderate" level of concern, and software verification and validation testing were conducted as per FDA guidance. However, this is for the device's core functionality (non-invasive blood pressure measurement using an oscillometric technique), not an AI-driven diagnostic or analytical tool.

In summary, this document is for a standard electronic blood pressure monitor, not a device incorporating a novel AI/ML algorithm that would require the detailed performance study and acceptance criteria you've asked for.

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Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures 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 cuff circumference is limited to 17cm-48cm (approx, 6 11/16"- 18 29/32").

Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified. If any irregular heartbeat is detected, it can be shown to the user.

The provided FDA 510(k) summary for the "Fully Automatic Electronic Blood Pressure Monitor" pertains to a Class II medical device, specifically a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are outlined, primarily focusing on the device's accuracy in measuring blood pressure and pulse rate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors are typically defined by international standards like ISO 81060-2. While the exact numerical criteria for "Criteria 1" and "Criteria 2" are not explicitly stated in this document (e.g., mean difference and standard deviation), the document states that the device "met criteria 1 and criteria 2 of ISO 81060-2."

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

• Sample Size: 231 patients (107 males and 124 females) were invited for the study.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective, as patients were "invited for the study" and a "standard auscultation method was used as the reference blood pressure monitor measuring," indicating a controlled clinical trial setting.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals (e.g., doctors, nurses) using a stethoscope and sphygmomanometer. The qualifications of the individuals performing the auscultation are not detailed in this document.

4. Adjudication Method for the Test Set

• The document states that the "standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen." This suggests that the reference measurements were obtained sequentially. There is no mention of a multi-reader/adjudication method for resolving discrepancies in ground truth establishment, as the auscultation method itself is the direct reference measurement.

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 document describes the validation of an automated blood pressure monitor, not an AI-assisted diagnostic tool where human readers interact with AI. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not relevant to this device's validation.

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

• Yes. The study evaluates the "Fully Automatic Electronic Blood Pressure Monitor" directly against a "standard auscultation method." This is an assessment of the device's standalone performance, as it operates automatically to provide blood pressure readings without a human actively interpreting or modifying its output during the measurement process.

7. The Type of Ground Truth Used

• Expert Consensus/Reference Standard: The ground truth was established using the "standard auscultation method." This is considered the clinical gold standard reference for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a validation study for a medical device's performance, not the development or training of an AI algorithm. Blood pressure monitors with oscillometric principles are based on established engineering principles and typically do not involve a "training set" in the context of machine learning model development. The document refers to "non-clinical tests" and a "clinical test," which relate to verification and validation of the device's design and performance against standards.

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

• Not applicable. As noted above, this section is not relevant to the type of device and validation described.

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This product is intended to measure systolic and diastolic blood pressure and pulse on upper arm of population over 12 years old in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)

Electronic blood pressure monitor, model: HTD6602US is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The proposed device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. It measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The HTD6602US is small, portable and used in home or medical facilities environment. The Electronic blood pressure monitor consists of two parts: main unit and cuffs. The HTD6602US is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 22cm32cm and cuff of size 22cm42cm.

Here's a breakdown of the acceptance criteria and the study details for the Electronic Blood Pressure Monitor, model: HTD6602US, based on the provided document:

Acceptance Criteria and Device Performance

Note: The primary acceptance criteria for accuracy are based on compliance with ISO 81060-2 Third Edition 2018-11, as indicated in the "Performance" row of the comparison table and the discussion of clinical accuracy testing. The specific numerical accuracy values are explicitly stated in the comparison table.

Study Details

The study that proves the device meets the acceptance criteria is a clinical accuracy test.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 85 subjects
• Data Provenance: Not explicitly stated, but since the submission is by Hetaida Technology Co., Ltd. from China and it's a 510(k) submission to the US FDA, it likely refers to a prospective clinical trial conducted to meet ISO standards. The document doesn't specify if the subjects were from a particular country.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated. The document refers to "reference equipment" (Sphygmomanometer - Stethoscope health box) and "Measuring Method: Auscultatory," which implies measurements were taken by trained personnel (e.g., medical professionals, technicians) using a standard, validated auscultatory method simultaneously with the device being tested.
• Qualifications of Experts: Not explicitly stated. However, for auscultatory measurements to establish ground truth in blood pressure studies, the personnel typically need to be trained clinicians or technicians adhering to standardized measurement protocols.

4. Adjudication Method for Test Set

• Adjudication Method: Not explicitly stated, but the method used for "ground truth" is "Auscultatory" measurements. In clinical blood pressure validation studies following ISO 81060-2, this usually involves at least two trained observers taking simultaneous readings (often blinded to each other's readings) and resolving discrepancies. The document mentions "Reference equipment used for measurements," implying a direct comparison to established, validated manual methods.

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

• Was an MRMC study done? No, this type of study is not applicable to a non-invasive blood pressure monitor that directly measures physiological parameters. MRMC studies are typically used for diagnostic imaging devices where human readers interpret images.

6. Standalone Performance Study

• Was a standalone (algorithm only without human-in-the-loop performance) study done? Yes, the entire clinical accuracy study evaluates the device's (algorithm's) performance in measuring blood pressure and pulse rate autonomously against a gold standard (auscultatory measurements). The device operates without human interpretation of its internal measurements; it directly provides readings.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus via Auscultatory Measurement Method using a reference Sphygmomanometer - Stethoscope health box. This is the gold standard for clinical validation of automated blood pressure devices.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable or not provided. This device is a hardware-based measurement system with an embedded algorithm, not a machine learning model that typically has a distinct training phase with labeled data in the same way. The algorithm's development (training) phase would occur during the device's engineering and calibration, not necessarily with a separate "training set" as understood in modern AI/ML contexts.

9. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable. As noted above, this isn't a typical AI/ML model where a training set with established ground truth is used for iterative learning. The accuracy of the device's algorithm would be refined through engineering and calibration processes based on physiological principles and potentially internal testing, not a "training set" of patient data in the same sense. The ISO 81060-2 clinical trial serves as the validation of the finalized algorithm's performance against clinical ground truth.

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Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries. Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. Electronic Blood Pressure Monitor can be divided into three models (YJ320, YJ321E, YJ326E) according to their appearance and functions.

The provided text is for an FDA 510(k) clearance for an Electronic Blood Pressure Monitor. It details non-clinical and clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a comprehensive table of non-clinical performance and safety acceptance criteria, along with the reported "Conclusion" (Pass/Fail). For the clinical validation, it states the acceptance criteria are met based on deviations from a reference standard.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

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The 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 at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

The Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor, comprised of the host machine and the wrist cuff. It can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can store 199 groups of measurement data for two users.

This document describes the regulatory approval of an Electronic Blood Pressure Monitor (Models HWA11, HWA10) by Shenzhen Jumper Medical Equipment Co., Ltd. The approval is based on demonstrating substantial equivalence to a predicate device (Omron Model BP6100, K182127).

The provided text does not contain detailed acceptance criteria or a comprehensive study plan with the specific information requested in the prompt (e.g., specific thresholds for accuracy, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC study details, etc.).

However, based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and the supporting study:

Implied Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily implied by conformance to international standards for blood pressure monitors and demonstration of statistical equivalence to a recognized measurement method.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Text):

Study Information (Extracted and Inferred):

1. Sample size used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The text mentions a "clinical investigation" but does not specify the number of subjects. However, for validation to ANSI/AAMI/ISO 81060-2:2013, a specific number of subjects (usually 85 for the initial phase, and more for specific populations) from a defined demographic (e.g., age and blood pressure ranges) are typically required.
   • Data Provenance: Not explicitly stated, but clinical studies for such devices are typically prospective. The text does not mention the country of origin where the clinical study was conducted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: "Trained medical staff" were used for the auscultation method. ANSI/AAMI/ISO 81060-2:2013 guidelines require specific training and certification for these observers.

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

   • No adjudication method is mentioned. The ground truth was established by "trained medical staff" using the auscultation method, implying a direct comparison rather than a multi-reader consensus process for image interpretation.

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:

   • No, an MRMC study was NOT done. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device. The "study" here refers to the clinical validation of its measurement accuracy compared to a standard reference method (auscultation), not a human-in-the-loop diagnostic improvement study.

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

   • Yes, in essence, this was a standalone performance study for the device. The study validated the "accuracy of blood pressure measurements by HWA11 based on an oscillometric method as compared to an auscultation method." This is the device's inherent performance.

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

   • Expert Reference Method (Auscultation): The ground truth for blood pressure measurements was established using the "auscultation method using a calibrated sphygmomanometer by trained medical staff." This is considered the gold standard for clinical blood pressure measurement in such validation studies.

7. The sample size for the training set:

   • This is not applicable for this type of device and study. The device is a non-AI, oscillometric blood pressure monitor. It uses a defined algorithm, not a machine learning model that requires a "training set" in the common AI sense.

8. How the ground truth for the training set was established:

   • Not applicable (see point 7).

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