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This device uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being's arm. All values can be read out in the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use. HL858DM features BP Category Indicator that will show the information with the readings on the user tracking their blood pressure level. HL858DM is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected. Besides, the device features a built-in "Bluetooth Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device.

HL858DM automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use. The device has the Risk Category Indicator, Irregular Heartbeat Detector, Bluetooth data transmission functions. When the symbol Advanced IHB appears on screen indicates the specific heartbeat irregularity was detected during measurement. Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, HL858DM featured with an IHB feature can identify the specific irregular heartbeats that may cause deviated blood pressure reading.

The device in question is the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM.

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the clinical validation. It only mentions that the device is compliant with ISO 81060-2:2018, which is the "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "All the relevant activities were performed by designate individual(s)."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical validation. ISO 81060-2 typically requires comparisons to expert observer measurements, but the specifics are not detailed here.

4. Adjudication Method for the Test Set:

• The document does not specify the adjudication method used for the test set.

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

• No MRMC comparative effectiveness study was done. This device is a blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve multiple human readers. The clinical validation focuses on the accuracy of the device's measurements against a reference method.

6. Standalone Performance Study:

• Yes, a standalone study was performed. The clinical validation was focused on the device's ability to accurately measure blood pressure and heart rate as a standalone system, in compliance with ISO 81060-2:2018. The document states, "The subject device HL858DM is compliant to the standard of ISO 81060-2:2018 Noninvasive sphygmomanometers- Part 2: Clinical validation of automated measurement type." This standard specifically outlines the requirements for clinical validation of automated blood pressure devices.

7. Type of Ground Truth Used:

• Based on compliance with ISO 81060-2:2018, the ground truth for blood pressure measurement is established through simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference oscillometric device. The standard dictates a rigorous protocol for comparison. The document does not explicitly detail the exact ground truth method used beyond referencing the standard.

8. Sample Size for the Training Set:

• This device is a hardware blood pressure monitor and does not explicitly use a "training set" in the context of machine learning algorithms for its core measurement function. Its measurement principle is based on oscillometry. The "training" in this context would refer to the calibration and internal algorithm development by the manufacturer, which is not detailed in the provided document.

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

• As noted above, this device does not have a "training set" in the machine learning sense. The underlying algorithms for oscillometric blood pressure measurement are developed and validated through engineering and physiological principles, and then verified through clinical trials like the one referenced.

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HL858CP automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.

The device can accurately measure in pregnant patients including those with known or suspected in preeclampsia condition.

HL858CP detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the user tracking their blood pressure level.

Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

HL858CP automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use. The device can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.

The device will display a symbol O-W- to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, when Triple Check mode is turned on by user, the symbol ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements.

HL858CP is equipped with Bluetooth Data Transmission function, which can electronic transfer the measured data of HL858CP to the paired Bluetooth-enabled device. The transferable measured data includes Systolic, Diastolic, and Pulse. The Bluetooth Data Transmission is without controlling or altering the functions or parameters of HL858CP and Paired Bluetooth-enabled device. In addition, the Bluetooth Data Transmission function could transfer the battery status of HL858CP to the Paired Bluetooth-enabled device without any controlling or altering on both devices.

Besides, Bluetooth Data Transmission function could provide Date/Time synchronization for HL858CP, which simply help users set Time/ Date information. It will help users prevent from entering incorrect time information.

The provided text describes the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP, and its clinical validation, particularly regarding its ability to accurately measure blood pressure in pregnant patients, including those with pre-eclampsia. This information is gleaned from various sections of the 510(k) Summary.

Here's a breakdown of the requested information:

Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical validation for non-invasive sphygmomanometers, including this device, is typically against the ISO 81060-2 standard. This standard sets specific criteria for accuracy.

Note: While the summary states that the criteria were fulfilled, the exact numerical performance values (mean difference and standard deviation) are not explicitly given in the provided text for either the general or pregnant populations. The summary focuses on meeting the standard.

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

• Sample Size for Test Set: "90 subjects with qualified distribution."
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, for a clinical validation study for a medical device approval, especially an accuracy study like this, it is almost exclusively prospective and generally conducted in a controlled clinical environment (e.g., a hospital or clinic). The lack of country specification likely means it was conducted where the manufacturer is based or in a region with established clinical trial infrastructure that is recognized by the FDA (e.g., often US, Taiwan, Europe).

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

The document does not specify the number or qualifications of experts used to establish the ground truth. For blood pressure measurement validation according to ISO 81060-2, the ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a validated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a rigorous protocol (e.g., auscultatory method with trained independent observers). The standard prescribes specific requirements for these observers.

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

The document does not explicitly describe an adjudication method for the test set. For ISO 81060-2 validation, the ground truth is typically captured by two independent observers (auscultatory method), and if there's a significant discrepancy, a third observer might be involved. The standard has specific requirements for the agreement between observers (e.g., differences within certain mmHg). While not explicitly stated as "adjudication," this method ensures robust ground truth.

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 device is a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The study described is a clinical validation of the device's measurement accuracy against a reference standard.

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

Yes, a standalone performance study was done. The entire clinical investigation described ("compliant to the standard of ISO 81060-2: Second Edition 2013-05-01") is a standalone algorithm (device) performance study. The device's measurements are directly compared to the clinically established ground truth, demonstrating the device's accuracy without requiring human interpretation or intervention in the measurement process beyond device operation.

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

The ground truth used is based on clinically established reference measurements of blood pressure, typically using the auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device) performed by trained medical professionals, as per the ISO 81060-2 standard. This is most akin to an expert consensus method from trained individuals applying a gold standard technique.

8. The sample size for the training set

The document does not specify a training set sample size. This is common for traditional medical devices like blood pressure monitors, which are validated against standards like ISO 81060-2 based on their mechanical and algorithmic adherence to established measurement principles, rather than being "trained" like machine learning models. The 90 subjects mentioned are for the clinical validation/test set.

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

As there is no "training set" in the context of machine learning for this device, a specific method for establishing ground truth for a training set is not applicable/not detailed. The device's internal algorithms for oscillometric blood pressure measurement are developed based on established physiological principles and engineering, not typically via a data-driven training process in the way AI models are.

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HL858CL automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.

HL858CL detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device.

HL858CL automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.

The device will display a symbol O-+-, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, when Triple Check mode is turned on by user, the symbol ( ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements. And user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

The provided text describes the 510(k) submission for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CL. The key study proving its performance is a clinical investigation conducted to demonstrate compliance with the standard ISO 81060-2: Second Edition 2013-05-01, "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type."

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for blood pressure monitors, as per ISO 81060-2, relate to the accuracy of BP measurements. While the exact numerical criteria for mean difference and standard deviation are not explicitly stated in the provided text, the document confirms that the device did meet these criteria. The text states: "The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858CL in the group of 90 subjects with qualified distribution."

(Note: The exact numerical values for 'mean difference' and 'standard deviation' were not provided in the document, only the statement that the 'required limits' were fulfilled.)

2. Sample Size and Data Provenance

• Sample Size for Test Set: 90 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical validation studies for medical devices are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish ground truth. For clinical validation of blood pressure monitors according to ISO 81060-2, the ground truth is typically established by trained human observers using a reference sphygmomanometer, often with simultaneous auscultation and standardized procedures, but no details are provided on the specific experts involved.

4. Adjudication Method for the Test Set

The document does not explicitly detail an adjudication method. In ISO 81060-2 studies, blood pressure measurements are typically taken by multiple observers (often two) and averaged or compared against a standardized reference, but specific adjudication processes (e.g., 2+1, 3+1) are not mentioned in this summary.

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

No, an MRMC comparative effectiveness study was not done. This device is a blood pressure monitor, which is typically validated for its standalone accuracy against a reference standard, not for human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, the study described is essentially a standalone performance study. The device's accuracy in measuring blood pressure is assessed against a reference standard (as per ISO 81060-2), which means it's evaluating the algorithm and hardware without human interpretation of ambiguous readings.

7. Type of Ground Truth Used

The ground truth for the clinical validation was established by comparison to a reference standard as dictated by ISO 81060-2. This typically involves simultaneous measurements by the device under test and trained observers using a calibrated auscultatory method.

8. Sample Size for the Training Set

The document does not provide information about a training set size. For blood pressure monitors validated to ISO 81060-2, the primary clinical study is a validation study, not a deep learning model's training. The device's algorithm would have been developed and refined using internal data, but details of that process (including training set size) are not part of this 510(k) summary for clinical validation.

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

As noted above, information about a "training set" and its ground truth is not provided in this regulatory summary, as the primary focus is on the clinical validation against the ISO standard.

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HL158UB automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.

HL158UB detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the user tracking their blood pressure level.

HL158UB automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 cm) and for home use.

The device will display a symbol ~, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, HL158UB has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist.

The provided text describes the HL158UB Full Automatic (NIBP) Blood Pressure Monitor and its compliance with regulatory requirements, including clinical and non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Study (Accuracy Test):
  • Sample Size: 100 valid subjects.
  • Data Provenance: Retrospective, conducted at Lohas Clinic in Taipei, Taiwan (R.O.C.), 2015-16.
• Usability Validation (Human Factors Test):
  • Sample Size: 60 valid subjects (recruited across four target groups).
  • Data Provenance: Prospective, conducted at Health & Life Co., Ltd. in Taipei, Taiwan (R.O.C.), 2018.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical accuracy test. It only mentions that the clinical study was conducted at Lohas Clinic and assessed compliance with ISO 81060-2:2013, which typically involves a comparison to a reference standard (e.g., auscultatory method by trained observers). However, no details on these observers are provided.

For the usability validation, the ground truth was based on observing user interactions and assessing if the device met usability goals and risk criteria as per IEC 62366-1, IEC 60601-1-6, and IEC 60601-1-11. This involves human factors engineers or usability specialists, but specific numbers and qualifications are not mentioned.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for the clinical accuracy study or the usability validation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a blood pressure monitor, not an AI-assisted diagnostic imaging tool.

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

Yes, the primary evaluation for the HL158UB blood pressure monitor (an algorithm-driven device) is inherently a standalone performance assessment. The "clinical study" described evaluates the device's accuracy against a recognized standard (ISO 81060-2:2013), which is a measure of its standalone performance in blood pressure measurement. The usability study also assesses the device's performance in interaction with users, without explicitly comparing it to human readers.

7. The Type of Ground Truth Used

• For Clinical Accuracy: The ground truth for blood pressure measurement accuracy would typically be established by a reference standard, such as auscultation (manual sphygmomanometry) performed by trained observers, as specified by standards like ISO 81060-2. While the document mentions compliance with ISO 81060-2, it does not explicitly state the specific ground truth method used beyond "clinical validation result."
• For Usability: The ground truth was based on observing user interactions and assessing the effectiveness, efficiency, ease of user learning, and user satisfaction against pre-defined usability goals and risk criteria. This is a form of empirical user performance data and expert evaluation.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set. The HL158UB is compared to its predicate device, HL158UA, and states that it uses the "same... algorithm." This suggests that the core algorithm may have been developed and "trained" (in a broader sense, if it involves any machine learning components, which is not explicitly stated for a blood pressure monitor) prior to this submission, possibly in the development of the predicate device or a similar platform. No specific training set data is mentioned for the HL158UB itself in this document.

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

As no specific training set is mentioned for the HL158UB, there is no information on how its ground truth would have been established. Given that it's a blood pressure monitor based on the oscillometric method, the "training" of such algorithms typically involves extensive physiological data, calibration, and validation against a gold standard for blood pressure measurement. However, this is not detailed in the provided text.

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HL158TB automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.

HL158TB detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the user tracking their blood pressure level.

HL158TB automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 cm) and for home use.

The device will display a symbol ♥*~, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

The provided text describes the submission for a medical device called the "Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TB." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (HL158TA, K160336).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document states that the subject device (HL158TB) and the predicate device (HL158TA, K160336) have the "same method of measurement, measure type, critical components (ex. air pump, sensor...) and algorithm." Therefore, the acceptance criteria and performance are implicitly aligned with the predicate device. The performance specifications are given in comparison to the predicate device.

Note: While the "Risk Category Indicator" and "Error icon" have been updated, the core accuracy and measurement parameters remain the same, implying the HL158TB meets the same performance acceptance criteria for blood pressure and pulse accuracy as the predicate.

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

The document states: "In ISO 81060-2 Second Edition 2013-05-01 Non-invasive sphygmomanometers-Part 2: Clinical validation of automated measurement type, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."

However, this statement refers to the predicate device (K160336). The document explicitly says, "clinical study results can be transferred from the K160336 predicate to the subject device." Therefore, the clinical validation for the subject device relies on the predicate's study.

• Sample size: Not specified for the predicate device's clinical validation study, only that it followed ISO 81060-2 which has specific patient number requirements (e.g., typically at least 85 subjects with specific age and blood pressure distributions).
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

This information is not detailed in the provided text for the clinical study of the predicate device. The ISO 81060-2 standard typically involves trained observers for ground truth measurements (using auscultation), but their specific number and detailed qualifications are not provided here.

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

This information is not detailed in the provided text. ISO 81060-2 outlines a specific methodology for collecting reference blood pressure measurements (often including multiple observers), but the specific adjudication method (e.g., 2+1) is not explicitly mentioned 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:

This is not applicable. The device is a "Full Automatic Blood Pressure Monitor" which automatically measures blood pressure. It does not involve "human readers" or "AI assistance" in the context of interpreting medical images or complex diagnostic data. Its primary function is a direct measurement.

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

Yes, the device is standalone. It is a "Full Automatic (NIBP) Blood Pressure Monitor." The clinical validation, transferred from the predicate device that followed ISO 81060-2, assessed the device's accuracy against reference measurements, which is an assessment of its standalone performance. The ISO 81060-2 standard is for the validation of automated sphygmomanometers.

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

For blood pressure monitors validated according to ISO 81060-2, the ground truth is typically established by cuff auscultation (e.g., by trained observers using a mercury sphygmomanometer), considered the gold standard for non-invasive blood pressure measurement in clinical validation studies.

8. The sample size for the training set:

This information is not provided. The document discusses clinical validation, which is an evaluation of the device's performance, not the training of an algorithm in the machine learning sense. While the device utilizes an oscillometric algorithm, details about its development or any training data used are not disclosed. The primary claim for HL158TB's performance relies on the transfer of clinical study results from its predicate, which shares the "same... algorithm."

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

This information is not provided. As mentioned above, details about algorithm development or training data are not available in this document.

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HL858DK automatically measures human's systolic, diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in the LCD panel. Measurement position is at human being's upper arm. The intended user of this over-the-counter device is adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) for home use.

HL858DK features BP Category Indicator that will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

HL858DK automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.

Additionally, after measurement, the BP Category Indicator feature will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858DK is equipped with an Advanced IHB detection feature to collect and analyze pulses. If the specific irregular heartbeats are detected and it may affect blood pressure reading with deviation, the device will give the user a warning signal. The feature can inform the user that the measured blood pressure reading may be inaccurate once the specific irregular heartbeats are detected.

The device referenced is the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DK.

Here's an analysis of its acceptance criteria and the study proving compliance:

1. Table of Acceptance Criteria and Reported Device Performance

The primary performance criterion for non-invasive blood pressure monitors, as per ISO 81060-2, relates to the accuracy of blood pressure and pulse measurements.

2. Sample Sizes and Data Provenance

• Test Set (Blood Pressure Accuracy):

  • Sample Size: 85 subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of a "clinical investigation" strongly suggests a prospective study specifically designed to validate the device's accuracy.

• Test Set (Advanced Irregular Heartbeat Detection):

  • Sample Size: 189 subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Similar to the BP accuracy study, this sounds like a prospective clinical test.

3. Number of Experts and Qualifications (for Ground Truth)

The document does not provide details about the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For blood pressure monitors, ground truth for clinical validation (e.g., according to ISO 81060-2) typically involves simultaneous auscultatory measurements performed by trained clinicians (often two or more) using a mercury sphygmomanometer or validated reference device. For IHB detection, the ground truth would typically be established by a reference ECG/EKG or similar cardiological assessment.

4. Adjudication Method for Test Set

The document does not explicitly describe the adjudication method used for establishing the ground truth (e.g., 2+1, 3+1). For ISO 81060-2 studies, simultaneous measurements by two independent observers are standard, with a third if discrepancies occur, but this specific detail is not provided.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted, nor is there any mention of an effect size for human readers improving with AI vs. without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance

Yes, a standalone performance study was clearly done. The clinical investigation directly assessed the performance of the device itself (HL858DK) against established standards for blood pressure accuracy (ISO 81060-2) and the performance of its Advanced Irregular Heartbeat Detection feature. There is no human-in-the-loop component described for these performance evaluations.

7. Type of Ground Truth Used

• Blood Pressure Accuracy: The explicit reference to "ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type" implies that the ground truth was established through simultaneous reference measurements (e.g., auscultatory measurements from trained observers using a calibrated reference device) on the same subjects. This is the standard method for validating automated blood pressure devices.
• Irregular Heartbeat Detection: While not explicitly stated, the ground truth for "Advanced IHB detection" performance (sensitivity and specificity) would typically be established by a reference electrocardiogram (ECG) or similar cardiological gold standard to confirm the presence or absence of irregular heartbeats.

8. Sample Size for Training Set

The document does not provide any information about a "training set" or its sample size. This suggests that the device's algorithms (e.g., for oscillometric measurement or IHB detection) were likely developed and validated internally by the manufacturer, and the described studies are the clinical validation/test sets for regulatory submission, not part of an AI model's training phase. Devices like this typically use established, non-AI algorithms.

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

As no training set is mentioned for an AI model, this question is not applicable based on the provided document. The device uses an oscillometric method (a well-established principle) and likely rule-based or signal processing algorithms for IHB detection, rather than a machine learning model requiring a distinct training pipeline and associated ground truth establishment.

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HL158UA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.

HL158UA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

HL158UA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 cm) and for home use.

The device will display a symbol wor ma, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, HL158UA has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist.

The provided text describes the 510(k) premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor model HL158UA. While it mentions clinical and non-clinical tests were performed and met acceptance criteria, it does not provide a detailed breakdown of the acceptance criteria nor the specific results of a study to prove the device meets these criteria in the format requested.

The text focuses on demonstrating substantial equivalence to a predicate device (HL158VA K160557) by comparing specifications and listing standards the device complies with.

Here's a breakdown of what can be extracted and what information is missing from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device is compliant with ISO 81060-2: Second Edition 2013-05-01 "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type." This standard defines the acceptance criteria for clinical accuracy of automated sphygmomanometers. However, the document does not explicitly list the acceptance criteria from this standard in a table, nor does it present the specific performance results from the clinical validation study against those criteria.

It only states: "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."

Based on the ISO 81060-2 standard, typical acceptance criteria for blood pressure monitors involve:

• Mean difference: The average difference between the device's readings and reference measurements (e.g., from a mercury sphygmomanometer).
• Standard deviation: The variability of these differences.

The typical acceptance criteria from ISO 81060-2 are:

• Mean difference ± Standard Deviation: ≤ ±5 mmHg for both systolic and diastolic blood pressure.
• Individual differences: Not more than 5 mmHg for a high percentage of measurements (e.g., 60% or 80%), and not more than 15 mmHg for nearly all measurements (e.g., 95%).

Since the document does not provide the specific reported device performance, I cannot fill in the "Reported Device Performance" column with actual numbers.

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

The document states compliance with ISO 81060-2 for clinical validation. This standard typically requires a minimum of 85 participants for clinical testing, covering a range of blood pressures and demographic characteristics.

• Sample size for the test set: Not explicitly stated, but inferred to be compliant with the minimum requirements of ISO 81060-2 (typically 85 subjects).
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). Clinical studies conforming to ISO standards are generally prospective.

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

The ISO 81060-2 standard requires that reference blood pressure measurements, which serve as the ground truth, be taken by two trained observers (experts) using auscultation with a mercury sphygmomanometer or an equivalent validated device. These observers must be trained and blinded to each other's readings and the results of the automated device.

• Number of experts: Not explicitly stated, but inferred to be at least two (as per ISO 81060-2).
• Qualifications of experts: Not specified (e.g., "radiologist with 10 years of experience"), but implied to be trained observers in blood pressure measurement as required by the ISO standard.

4. Adjudication method for the test set

The ISO 81060-2 standard specifies a method for comparing the automated device's readings with reference measurements taken by two trained observers. It typically involves averaging the two observers' readings or comparing discrepancies. If there's a significant difference between the two observers, a third observer might be involved, or the measurement discarded.

• Adjudication method: Not explicitly stated, but inferred to follow the methodology outlined in ISO 81060-2 for comparison against two independent observers' readings.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret images with or without AI assistance. The device in question is a non-invasive blood pressure monitor, and its validation revolves around direct measurement accuracy, not interpretation by human readers.

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

Yes, the clinical validation described as compliant with ISO 81060-2 is inherently a standalone performance test for the device's algorithm. The standard assesses the device's ability to accurately measure blood pressure readings independently against a reference standard. While a human initiates the measurement, the accuracy evaluation focuses on the automated device's output.

7. The type of ground truth used

The ground truth for blood pressure monitors validated to ISO 81060-2 is established by expert auscultation measurements using a reference standard like a mercury sphygmomanometer. This involves trained observers listening to Korotkoff sounds.

• Type of ground truth: Expert auscultation measurements (reference standard blood pressure readings).

8. The sample size for the training set

The document does not provide information on a training set sample size. This is typical for a medical device cleared via substantial equivalence, especially for a blood pressure monitor. While the device's development likely involved internal data for calibrating the oscillometric algorithm, the 510(k) summary only focuses on the validation against established standards. The ISO 81060-2 standard is for clinical validation, not algorithm training.

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

As no training set information is provided in the document, this cannot be answered. If a training set were used for algorithm development, its ground truth would typically be established similarly to the validation set—i.e., through expert auscultation or other highly accurate reference methods.

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HL158VA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over the counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.

HLI S8VA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

HL158VA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 cm) and for home use.

The device will display a symbol wor or to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

Besides, HL158VA has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist. Furthermore, the user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.

The document discusses the Food and Drug Administration's (FDA) review of the Full Automatic (NIBP) Blood Pressure Monitor, Model HL158VA. It determined the device to be substantially equivalent to previously marketed predicate devices.

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

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

The primary clinical performance acceptance criteria for the blood pressure monitor are related to its accuracy, as per ISO 81060-2.

Additional Technical Specifications:

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

• Sample Size: A "group of 100 subjects" was used for the clinical investigation.
• Data Provenance: The document does not specify the country of origin. The study was a prospective clinical investigation, designed to evaluate the device against a known standard.

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)

The document does not provide details on the number or qualifications of experts used to establish the "ground truth" (reference blood pressure measurements). In ISO 81060-2 clinical validation, this typically involves trained observers taking auscultatory measurements using a mercury sphygmomanometer in a standardized manner.

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

The document does not explicitly describe an adjudication method for the test set. For ISO 81060-2 clinical validation, measurements from multiple trained observers are often compared to minimize individual observer bias, but a formal "adjudication" in the sense of resolving discrepancies is not typically described in summary documents like 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a standalone blood pressure monitor and does not involve human readers analyzing medical images with or without AI assistance.

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

Yes, a standalone performance evaluation was conducted. The clinical investigation directly evaluated the accuracy of the device (HL158VA) against the ISO 81060-2 standard, which assesses the device's ability to measure blood pressure without human intervention influencing the measurement itself (though a human operates the device).

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

The ground truth for the clinical validation was based on reference blood pressure measurements taken by trained observers, as specified by the requirements of the ISO 81060-2 standard for non-invasive sphygmomanometers. This is a form of "expert measurement" or "reference method."

8. The sample size for the training set

The document does not mention a training set sample size. For medical devices like this, which measure physiological parameters using established principles (oscillometric method), a "training set" in the machine learning sense is not typically used or reported for regulatory submissions; rather, the device's algorithms are developed and then validated through clinical studies.

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

As no training set (in the machine learning sense) is mentioned, there's no information on how its ground truth was established. The device's underlying algorithm is based on the well-established oscillometric method, and its accuracy is validated directly on a test set (the 100 subjects) rather than through a separate training/validation split typical of AI systems.

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HL858TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.

HL858TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

HL858TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.

The device will display a symbol ( heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

The provided document describes the K161156 premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA. This device is a non-invasive blood pressure measurement system.

Here's the breakdown of the acceptance criteria and study proving the device meets them:

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

The key performance acceptance criteria for non-invasive blood pressure monitors are typically defined by recognized standards like ISO 81060-2. The document explicitly states compliance with ISO 81060-2. This standard specifies limits for the mean difference and standard deviation between the device's measurements and reference measurements.

While the exact numerical thresholds specified by ISO 81060-2 are not explicitly listed in this FDA summary document, the summary states:

In addition to the clinical validation, the device also meets the following technical performance criteria, which are often derived from predicate device performance and relevant standards:

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

• Test Set Sample Size: 105 subjects (used for the clinical investigation compliant with ISO 81060-2).
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for these types of devices are typically prospective in nature, as they involve actively taking measurements on subjects under controlled conditions to compare against a reference method.

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

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. However, for a clinical validation compliant with ISO 81060-2, the ground truth is established by simultaneous measurements using a reference standard, usually by trained operators (e.g., medical professionals using a mercury sphygmomanometer or an equivalent calibrated method). The standard specifies the requirements for these reference measurements and the personnel performing them.

4. Adjudication method for the test set

The document does not mention an adjudication method in the context of human readers or image interpretation, as this device measures physiological parameters directly. For blood pressure measurements, the "adjudication" is inherent in the direct comparison against a reference standard measurement, often performed simultaneously by a trained human operator.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices where human interpretation is involved. The HL858TA is a direct measurement device and does not involve human interpretation of complex images aided by AI.

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

This refers to the performance of the algorithm without human interaction. For this device, the "algorithm" is the oscillometric method and its processing of the pressure signals to determine BP and heart rate. The clinical validation described in the document (ISO 81060-2) directly assesses the performance of this algorithm in a standalone manner (albeit with a human applying the cuff and initiating the measurement), comparing its output to a reference standard. Therefore, a standalone performance assessment was done.

7. The type of ground truth used

The ground truth used was simultaneous measurements by a validated reference method (e.g., mercury sphygmomanometer) as per the requirements of ISO 81060-2. This is a form of direct physiological measurement ground truth, not pathology, outcomes data, or expert consensus (in the sense of interpreting subjective data).

8. The sample size for the training set

The document does not specify the sample size for a training set. This is because the device is not based on machine learning in the conventional sense (where a model is "trained" on a large dataset). It uses an established oscillometric method. Its calibration and internal algorithms are based on fundamental principles of blood pressure measurement, rather than a data-driven training process that requires a distinct "training set."

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

As there is no "training set" in the machine learning sense, there is no ground truth established for it. The device's underlying principles are based on established biophysics and engineering, validated through rigorous clinical testing on a test set (as described in point 2).

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HL158TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.135 mm to 195 mm) and for home use.

HL158TA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.

HL158TA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.135 mm to 195 mm) and for home use.

The device will display a symbol ( heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.

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

Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TA
Predicate Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL158BT (K093824)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 85 subjects for the clinical investigation (ISO 81060-2).
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the clinical investigation was performed.

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

The document does not provide information about the number of experts or their qualifications for establishing the ground truth in the clinical study. However, the ISO 81060-2 standard for non-invasive sphygmomanometers typically requires measurements by trained observers or reference devices to establish ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the test set in the clinical study. ISO 81060-2 standards involve comparison against auscultatory blood pressure measurements, often performed by multiple trained observers to mitigate error.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a clinical validation study against a recognized standard (ISO 81060-2) for objective performance, not a study comparing human reader performance with and without AI assistance. The device is an automated blood pressure monitor, not an AI diagnostic tool that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary clinical study described for the HL158TA is a standalone performance study of the device's accuracy in measuring blood pressure, as required by ISO 81060-2. This standard evaluates the algorithm and hardware's ability to accurately measure blood pressure independently of human interpretation of readings, although human subjects are part of the measurement process. The device provides "Full Automatic" measurements.

7. The Type of Ground Truth Used

For the clinical study (ISO 81060-2), the ground truth for blood pressure measurements is typically established through auscultatory measurements performed by trained observers using a reference sphygmomanometer. This is the standard reference method against which automated devices are validated.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It focuses on the clinical validation (test set) for regulatory submission.

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

The document does not provide information on how the ground truth for the training set was established, as a training set is not explicitly mentioned or detailed in the regulatory submission information provided. This information is typically proprietary to the device manufacturer and not always included in 510(k) summaries, which focus on safety and effectiveness demonstration rather than development details.

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