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Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor.

The device is widely used for home healthcare, medical institutes and many other occasions.

The provided text describes the regulatory clearance of a Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) and details the testing done to prove its substantial equivalence to a predicate device. This is not an AI/ML device, and thus, many of the requested elements for AI/ML device studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not found in the provided document.

However, I can extract information related to the acceptance criteria and the study that proves the device meets (or is equivalent to) those criteria for a traditional medical device, specifically a thermometer.

Here's a breakdown of the requested information, adapted to the context of a thermometer and the provided document:

Acceptance Criteria and Device Performance for Non-contact Forehead Infrared Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

For medical thermometers, the primary acceptance criteria revolve around measurement accuracy and clinical performance. The document refers to compliance with specific international standards.

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

• Sample Size: A minimum of 143 subjects were used for the clinical study. These subjects were divided into three age groups:
  • Group A1: 0 up to 3 months (Infant group)
  • Group A2: 3 months up to 1 year (Infant group)
  • Group C: Older than 1 to 5 years old (Child group)
  • Group B and C: Above 5 years old (Adult group) - Note: The document lists B Child group (Older than 1 to 5 years old) and C group older than 5 years old. This seems to be a minor typo in the extract formatting, grouping A and B as infant and child, and then C as older. The key is that multiple age groups were tested.
• Data Provenance: The document does not explicitly state the country of origin of the clinical data. It states the study was a "randomization, simple blind homologous control, pairing design of clinical investigation." It is a prospective clinical study as it involved conducting tests with human subjects.

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

This information is not applicable and not provided in the context of a non-contact infrared thermometer's clinical accuracy study. For such a device, a "ground truth" is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a rectal thermometer) as per the ASTM E1965 standard, rather than expert consensus on images or interpretations. The expertise required would be in the conduct of the clinical study itself, ensuring proper procedure and data collection.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple readers, common in diagnostic imaging. For a thermometer, the "ground truth" is a measured temperature value, not a subjective interpretation requiring adjudication among experts. The study design mentions "simple blind homologous control, pairing design."

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. The device is a Non-contact Forehead Infrared Thermometer, not an AI/ML-powered diagnostic imaging device involving human readers or AI assistance in interpretation.

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

This information is not applicable in the context of an AI algorithm. The device itself is the "standalone" product, measuring temperature. Its performance is evaluated directly through non-clinical and clinical testing, not as an algorithm interpreting data for a human.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established by comparative temperature measurements against a reference method (likely rectal or oral temperature, as per ASTM E1965-98 standards for clinical thermometers). The study assessed the device's accuracy in relation to these established body temperature measurements. It is explicitly stated that the study followed ASTM E1965-98, which is a standard for clinical accuracy of infrared thermometers.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The document describes a traditional medical device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is hardware-based, relying on infrared physics, not trained on a dataset of images or other input data.

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

This information is not applicable. As stated above, this is not an AI/ML device with a "training set."

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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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This blood pressure monitor (Model: FC-BP20), FC-BP201, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.

The subject device, Wrist Electronic Blood Pressure Monitor, is an automatic noninvasive blood pressure monitor which can be driven by AAA alkaline battery, DC3V. It uses an inflatable cuff which is wrapped around the patient's wrist 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 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 according to WHO recommendation, 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 Heart Beat (IHB) (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 through Bluetooth LE4.2 to paired Bluetooth-enabled device (FC-BP200, FC-BP210, FC-BP220 and FC-BP221 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-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221. Six models are identical in terms of software design, cuff type and measurement range. The schematic circuit diagram are identical in all models except for model FC-BP220. Six models PCB layout are different because of different appearance (such as structure, buttons layout, etc.) and function.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrist Electronic Blood Pressure Monitor (K231367):

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a full clinical study report. Therefore, some of the requested information, particularly regarding the internal workings of the "AI" (which appears to be an oscillometric method, not AI in the modern sense) and detailed expert qualifications, is limited.

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: 130 subjects.
   • Data Provenance: The document states "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement." It does not specify the country of origin, but given the manufacturer's location (Shenzhen, China) and the correspondent's location (Shanghai, China), it's highly probable the study was conducted in China.
   • Retrospective or Prospective: Prospective, as it involved "actual clinical trial" with volunteers.

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: Not explicitly stated. The ground truth method was "Auscultation applied as gold standard with the qualified calibrated mercurial sphygmomanometer." This implies trained medical professionals (e.g., doctors or nurses) were performing these measurements, but their specific qualifications or number are not detailed.

3. Adjudication method for the test set:

   • Not explicitly described. The text mentions "Auscultation applied as gold standard" and comparison with the subject device. It doesn't detail if multiple auscultation readings were taken and adjudicated.

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, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This study was a clinical validation of an automated non-invasive sphygmomanometer against a gold standard, not an AI-assisted diagnostic study. The "AI" mentioned in the request refers to a modern interpretation of AI; this device uses the "oscillometric method" which is an automated algorithm but not typically categorized as advanced AI in the context of diagnostic image interpretation or complex decision support.

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

   • Yes, the performance test described is essentially a standalone algorithm performance test. The device (algorithm) measures blood pressure independently, and its readings are compared to the gold standard (auscultation). The device is an automated non-invasive sphygmomanometer.

6. The type of ground truth used:

   • Expert consensus (indirectly): The primary ground truth was "Auscultation applied as gold standard with the qualified calibrated mercurial sphygmomanometer." Auscultation is performed by human operators. While not explicitly stated as "expert consensus" in terms of multiple experts reaching agreement after individual assessments, it relies on human expert measurement as the reference.

7. The sample size for the training set:

   • The document does not provide information about a separate training set. For devices like automated blood pressure monitors, the underlying oscillometric algorithms are typically developed and refined using extensive datasets during their engineering phase, but this information is not part of the clinical validation study cited here. The ISO 81060-2:2018 standard focuses on clinical validation, not algorithm development.

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

   • Not applicable/Information not provided, as no training set details are given in this document.

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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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The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.

FC-IR series infrared thermometers (Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display.
The device is intended to be used in the home setting and medical institutes.
The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries.
It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer.
In addition, when measuring the ear temperature, the ear cover must be used by all thermometer models except for the FC-IR200. FC-IR101 model incorporates Bluetooth technology to wirelessly transmit temperature reading to an APP.

The provided text describes the 510(k) premarket notification for the Shenzhen Finicare Co., Ltd. Infrared Thermometer (models FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400). The documentation focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Brav Electronic Technologies Co., Ltd., EFT-165 Infrared Thermometer /K171214), rather than presenting a standalone study proving the device meets specific acceptance criteria for a novel AI/ML-based diagnostic/screening tool.

Therefore, the information requested in the prompt (specifically regarding acceptance criteria, expert opinion, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML) is not applicable to this traditional medical device clearance. The document outlines a performance study for a thermometer, not an AI/ML-driven diagnostic device.

However, I can extract the information relevant to the performance testing of the Infrared Thermometer as described:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on adherence to recognized standards and comparative equivalence to a predicate device rather than presenting a specific table of device-specific acceptance criteria with corresponding performance numbers in the way one would for an AI/ML system.
The key "acceptance criteria" for this type of device are primarily compliance with accuracy standards and other regulatory requirements.

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

• Sample Size for Clinical Study: A minimum of 144 subjects across various age groups.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It implies a prospective clinical study given "clinical testing was conducted".

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

• Not applicable / Not explicitly stated. For a clinical thermometer, true core body temperature obtained via a reference method (e.g., rectal thermometer for infants, oral or axillary for adults where appropriate) serves as the ground truth. This is not a diagnostic device requiring expert consensus for image interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. This device measures temperature, and its accuracy is validated against established temperature measurement methods, not through an adjudication process of human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is for evaluating human reader performance with and without AI assistance for diagnostic tasks. This is a thermometer, not an AI diagnostic tool.

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

• Not applicable directly as an "algorithm." The core "algorithm" is the thermometer's internal processing for temperature conversion. The bench testing and clinical testing evaluate the device's standalone performance in measuring temperature.

7. The Type of Ground Truth Used:

• Clinical temperature measurements from subjects (presumably against a reference standard thermometer). The clinical study was conducted per ASTM E 1965-98 (2009) "Standard Specification for Infrared Thermometers For Intermittent Determination Of Patient Temperature," which outlines methods for establishing this ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This is a hardware device with embedded software, not a machine learning model developed with a distinct "training set" in the AI sense.

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

• Not applicable. (See point 8).

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