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Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

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

Device: Automatic Upper Arm Blood Pressure Monitor (Models: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document states: "The whole product and manufacturing used for the Automatic Upper Arm Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards: ... AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)."

However, the document does not directly provide the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the clinical validation of the subject device itself. Instead, it refers to prior validation of the predicate devices. To get this information, one would need to consult the 510(k) submissions for predicate devices K153552 and K172895, as the subject device is deemed "substantially equivalent" to them based on these prior validations.

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

The document refers to the AAMI / ANSI / ISO 81060-2 standard for clinical validation. This standard typically involves trained observers (often medical professionals) to perform auscultatory blood pressure measurements, which serve as the ground truth.

However, the specific number of experts and their qualifications for the predicate device studies (which this device relies upon) are not explicitly stated in this 510(k) summary. The standard implicitly dictates the methodology for such experts to ensure accuracy.

4. Adjudication Method for the Test Set:

The document refers to the AAMI / ANSI / ISO 81060-2 standard. This standard specifies a rigorous methodology for obtaining reference blood pressure measurements, often including:

• Utilizing trained observers.
• Taking multiple consecutive measurements.
• Calculating the average of these measurements as the reference.
• Potentially discarding outlying measurements.

However, the specific adjudication method (e.g., 2+1, 3+1, none) used in the predicate device studies is not detailed in this 510(k) summary. One would need to refer to the original validation reports for the predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:

This device is an Automatic Upper Arm Blood Pressure Monitor and does not involve AI assistance for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed. The device takes direct measurements.

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

Yes, the device is an "Automatic Upper Arm Blood Pressure Monitor," indicating it operates in a standalone manner to measure blood pressure and pulse rate without continuous human interpretation or input during the measurement process. The clinical validation, by referring to AAMI / ANSI / ISO 81060-2, assesses the device's accuracy in autonomously taking these measurements against a reference standard.

7. The Type of Ground Truth Used:

The ground truth for blood pressure measurement, as stipulated by standards like AAMI / ANSI / ISO 81060-2, is typically established by trained observers using a validated reference method, such as auscultatory blood pressure measurement performed by healthcare professionals. This involves a mercury sphygmomanometer or an equivalent calibrated non-invasive device, with readings taken by at least two independent observers.

8. The Sample Size for the Training Set:

The document states: "All hardware and software of the subject device are based on that of the predicate device K153552 and K172895 since no new testing is presented in the submission." This implies that no new training set was explicitly created or used for the subject device beyond what was used for the predicate devices.

The text does not provide details on the training set or its size for the development of the oscillometric algorithm in either the subject device or its predicates. Blood pressure monitors using the oscillometric method are typically developed and calibrated by engineering teams using various physiological data and signal processing techniques. The "training" here refers more to the engineering development and calibration process rather than a machine learning training set with annotated data.

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

As mentioned above, the development of an oscillometric blood pressure monitor involves engineering development and calibration. The "ground truth" during this development phase would typically involve:

• Reference blood pressure measurements: Using highly accurate, invasive (e.g., intra-arterial) or highly precise non-invasive (e.g., mercury sphygmomanometer with trained observers) methods during the development and calibration of the oscillometric algorithm.
• Physiological models and simulations: To refine the algorithm's ability to interpret oscillometric waveforms.
• Extensive testing against a range of patient populations: To ensure the algorithm performs robustly across different physiological conditions.

However, specific details on the ground truth establishment for the training set (developmental calibration) are not provided in this 510(k) summary. Such details would typically be part of the manufacturer's internal design and development files. The 510(k) summary primarily focuses on the clinical validation against established standards for regulatory approval.

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Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Automatic Upper Arm Blood Pressure Monitor:

This document is a 510(k) Summary for a medical device called "Automatic Upper Arm Blood Pressure Monitor" (Model: BA-815, BA-816) by DONGGUAN E-TEST TECHNOLOGY CO., LTD. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document states: "All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission." This means that the acceptance criteria and performance data presented implicitly refer to the predicate device, as the subject device is deemed identical.

Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure monitor. The performance criteria are defined by the standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.

Study Details (Based on the predicate device's compliance with AAMI / ANSI / ISO 81060-2)

Since "no new testing is presented in the submission" and the subject device is identical to the predicate, the compliance is based on the predicate device's clinical validation to AAMI / ANSI / ISO 81060-2 Second Edition. This standard outlines the requirements for clinical validation studies for automated non-invasive sphygmomanometers. The details below are inferred requirements from that standard, as the specific clinical study report is not provided in this 510(k) summary.

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

   • Sample Size: The AAMI / ANSI / ISO 81060-2 standard generally recommends a minimum of 85 participants for clinical validation studies, with a balanced distribution across age groups, genders, and blood pressure ranges (normotensive, hypertensive, hypotensive) to ensure robustness. The document does not explicitly state the sample size used in the predicate's study.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies according to AAMI are typically prospective in nature, conducted in a controlled clinical environment.

2. 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 AAMI / ANSI / ISO 81060-2 standard requires at least two trained observers (experts) to perform simultaneous auscultatory measurements using a mercury sphygmomanometer as the reference standard (ground truth). These observers should be blinded to each other's readings and to the device under test.
   • The standard typically requires observers to be medically trained professionals (e.g., physicians, nurses) with demonstrated proficiency in indirect blood pressure measurement. Specific years of experience are not explicitly stated in the general overview of the standard but implied through training and certification. The document does not explicitly state the number or qualifications of experts for the predicate's study.

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

   • The AAMI / ANSI / ISO 81060-2 standard outlines specific protocols for comparing the automated device readings against the auscultatory measurements. If the two observers' readings differ by more than a predefined threshold, a third observer ("2+1") or a repeat measurement might be required to establish the ground truth or resolve discrepancies.
   • The document does not explicitly state the adjudication method used for the predicate's study, but a standard compliant study would have such a method.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging analysis or diagnostic aids where human interpretation is assisted by AI. This device is an automated blood pressure monitor; it does not involve human "readers" or AI assistance for interpretation in the same way an imaging system would. It provides direct numerical outputs for blood pressure and pulse rate.

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

   • Yes, a standalone study was done. The clinical validation per AAMI / ANSI / ISO 81060-2 is fundamentally a standalone clinical performance study. The automatic blood pressure monitor operates on its own, providing measurements, and its performance is compared directly against the reference standard (auscultatory method). There is no "human-in-the-loop" for the device's measurement process itself, although human interaction is required to apply the cuff and initiate the measurement.

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

   • The ground truth used for validating the accuracy of non-invasive blood pressure monitors under AAMI / ANSI / ISO 81060-2 is simultaneous auscultatory measurement performed by trained human observers using a mercury sphygmomanometer. This is considered the clinical reference standard for indirect blood pressure measurement.

7. The sample size for the training set:

   • Since no new testing was performed for the subject device and it is stated that "All hardware and software of the subject device are based on that of the predicate device," there is no specific mention of a training set for the subject device or for the predicate device's original validation. Automated blood pressure monitors are often developed and calibrated using internal data, but the AAMI validation focuses on clinical performance rather than a 'training/test' split akin to machine learning models. If the device uses a machine learning algorithm, the training set details would typically be proprietary and not disclosed in a 510(k) summary (unless it directly impacts the safety and effectiveness and needs specific validation).

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

   • As there's no explicitly mentioned "training set" in the context of this 510(k) summary, the method for establishing its ground truth is not provided. For the initial development and calibration of such a device, ground truth would likely be established through a combination of simulated physiological signals and clinical data obtained using reference methods like direct intra-arterial measurements or auscultatory measurements.

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AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.

AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.

The provided text describes a 510(k) submission for an Automatic Upper Arm Blood Pressure Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on a clinical trial.

Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and human-in-the-loop performance are not available in this document, as they are typically associated with performance validation studies for AI/ML devices or new diagnostic methods, not blood pressure monitors seeking 510(k) clearance based on substantial equivalence to an existing device.

However, I can extract the relevant information regarding performance standards and comparisons that are mentioned:

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

The document references the standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type as the key performance standard.

While explicit acceptance criteria are not listed in a table, the standard itself defines accuracy requirements for blood pressure monitors. The device claims the following accuracy, which would implicitly be the performance criteria it aims to meet based on the standard:

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

The document states that the device was evaluated for "safety and performance by lab bench testing" and refers to "Clinical Validation Of Automated Measurement Type" according to ISO 81060-2.

• Sample Size: The document does not explicitly state the sample size (number of subjects/measurements) used for the clinical validation. ISO 81060-2 typically specifies minimum patient numbers (e.g., 85 subjects for validation). Without the full study report, the exact sample size cannot be determined from this document.
• Data Provenance: Not explicitly stated. Clinical validation studies for such devices typically involve prospective data collection from human subjects. The document does not specify the country of origin.
• Retrospective/Prospective: Clinical validation according to ISO 81060-2 is inherently prospective, involving live measurements on human subjects.

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

For blood pressure monitor validation (ISO 81060-2), ground truth is established by simultaneous auscultatory measurements performed by trained observers (commonly two, with a third if disagreements arise) using a reference sphygmomanometer. These are not "experts" in the sense of radiologists interpreting images, but rather trained technicians or clinicians. The document does not specify the exact number of observers or their specific qualifications, but the standard mandates specific training and performance for these observers.

4. Adjudication method for the test set

The ISO 81060-2 standard typically employs an adjudication method for reconciling reference blood pressure measurements. Commonly, two trained observers simultaneously measure, and if their readings differ by more than a predefined threshold, a third observer might be used, or the measurements are discarded and re-taken. This is inherent to the standard's methodology, though not explicitly detailed in this summary document.

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, an MRMC study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often with AI assistance (e.g., radiology AI). This device is an automatic blood pressure monitor, not an interpretive diagnostic system.

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

Yes, in essence. The primary performance evaluation for an automatic blood pressure monitor is its standalone accuracy against a reference method (auscultation). The device itself is designed to operate automatically, without continuous human intervention during the measurement cycle for interpretation. The reported accuracies (±3 mmHg for pressure, ±5% for pulse) reflect this standalone performance.

7. The type of ground truth used

The ground truth for non-invasive blood pressure monitors typically involves simultaneous auscultatory measurements performed by trained observers using a mercury or an equivalent validated reference sphygmomanometer. This is the "gold standard" for clinical validation of automated blood pressure devices as per ISO 81060-2.

8. The sample size for the training set

This document does not specify a separate "training set" sample size. For traditional medical devices like blood pressure monitors, there isn't typically a distinct "training set" in the machine learning sense. The device's algorithm (oscillometric method) is developed based on physiological principles and engineering, not "trained" on a large dataset of patient readings in the way an AI algorithm learns. The validation is done on a "test set" or clinical study population.

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

As there isn't a "training set" in the AI/ML sense, this question is not applicable. The device's internal algorithms are based on established oscillometric principles for blood pressure determination. Their accuracy is then validated (tested) against the clinical ground truth described in point 7.

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AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is six sizes.

AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for a blood pressure monitor. It serves as a regulatory approval and states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the necessary safety and effectiveness standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the AGE Automatic Upper Arm Blood Pressure Monitor are primarily established by compliance with recognized standards for safety and performance. The document explicitly states the required accuracy for pressure and pulse measurements.

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

The document explicitly states that the device's safety and performance were evaluated by "lab bench testing" and "clinical validation" according to ISO 81060-2.

• Sample Size: The document does not specify the precise sample size used for the clinical validation. ISO 81060-2, the standard followed, dictates specific subject requirements for clinical validation of automated sphygmomanometers (e.g., specific age groups, blood pressure ranges, and a minimum number of subjects, typically at least 85 subjects with appropriate distribution). However, the number of subjects used in this specific study is not provided in the excerpt.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it's a 510(k) submission for a device manufactured in China, it's plausible the clinical study was conducted in China or another region that uses ISO standards, likely a prospective study to collect human blood pressure measurements.

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

The document refers to compliance with ISO 81060-2 for clinical validation. This standard typically requires "reference measurements" (ground truth) to be obtained by healthcare professionals using a standardized method (e.g., mercury sphygmomanometry with a stetho-scope).

• Number of Experts: ISO 81060-2 usually requires at least two trained observers (experts) for simultaneous, blind auscultatory measurements to establish the reference blood pressure. The document itself does not specify the exact number of experts.
• Qualifications of Experts: The standard implies that these experts are trained and competent in auscultatory blood pressure measurement. While "radiologist with 10 years of experience" is an example qualification, for blood pressure measurement, the standard would typically require medical professionals trained in auscultatory blood pressure measurement, such as physicians, nurses, or trained technicians, without specifying years of experience in this excerpt.

4. Adjudication Method for the Test Set

For the clinical validation against ISO 81060-2, the ground truth is established by simultaneous auscultatory measurements by two trained observers.

• Adjudication Method: While not explicitly detailed, ISO 81060-2 requires a pre-defined method for handling discrepancies between the two observers' readings. Common methods include:
  • Averaging the two readings if they are within a specific tolerance.
  • Using a third, independent observer if the initial two readings differ by more than a specified amount (e.g., 2+1 methodology).
  • No adjudication is typically not acceptable for establishing ground truth in this type of study; a consensus or defined reconciliation process is necessary to minimize observer bias. The exact method used for this device's validation is not detailed in the provided text.

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, an MRMC comparative effectiveness study was not done. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improving with AI assistance" is not applicable. The study's purpose was to validate the accuracy of the automated device itself against a human-read reference standard.

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

• Yes, in spirit, a standalone performance study was done. The device itself is an automated system that measures blood pressure. The clinical validation conducted under ISO 81060-2 assesses the accuracy of the device's algorithm (its automated measurement) compared to the "gold standard" of human-observed auscultatory blood pressure. There isn't a "human-in-the-loop" in the operation of the device for each measurement; it's designed to be automated.

7. The Type of Ground Truth Used

• The ground truth for the clinical performance evaluation (per ISO 81060-2) would be expert consensus auscultatory blood pressure measurements, typically performed simultaneously and blindly by two trained observers using a mercury sphygmomanometer or equivalent calibrated device. This is the accepted clinical gold standard for such validations.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This document describes a 510(k) submission for a traditional medical device (an automated blood pressure monitor) that operates based on oscillometric principles, not explicitly on machine learning or deep learning algorithms that require separate "training sets." The device's underlying algorithm is likely fixed and validated, not something that "learns" from a training dataset in the AI sense. Therefore, there's no mention of a "training set" as one would find for an AI/ML medical device.

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

• Not applicable. As explained in point 8, this device does not appear to utilize a machine learning model that would require a "training set" with established ground truth in the context of AI/ML development. Its accuracy is validated against a reference standard in a clinical study.

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AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 24~34 cm.

AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the oscillometric technique. The device also has low voltage indication, which will be triggered when the battery is low.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AGE Automatic Upper Arm Blood Pressure Monitor:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the device is "complied with AAMI SP10," which implies that the device meets the quantitative accuracy requirements specified in that standard. The table above extracts these specific numerical accuracy criteria.

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

• Test Set Sample Size: Not explicitly stated in the provided text. The document mentions evaluation against standards, particularly AAMI SP10, which typically specifies sample sizes for clinical validation (e.g., typically 85 subjects for blood pressure monitors as per AAMI/ISO 81060-2). However, the exact number of subjects used in the validation study for this specific device is not provided in this summary.
• Data Provenance: The report is submitted by Ageless Health Industrial Ltd., located in Dongguan City, Guangdong Province, China. The document does not specify the country of origin of the data itself. It's a "510(k) submission report (V1.0), Chapter 6." The study appears to be prospective as it's a submission for pre-market clearance, implying new testing to demonstrate compliance.

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

• This information is not provided in the given text. For blood pressure monitor validation studies (e.g., per AAMI/ISO 81060-2), ground truth is typically established by trained observers (e.g., physicians or specially trained nurses) who take auscultatory blood pressure readings using a mercury sphygmomanometer or validated equivalent, often in triplicate, to establish reference values. However, the details of such experts and their qualifications are not present here.

4. Adjudication Method for the Test Set

• This information is not provided in the given text. For clinical validation studies, adjudication methods (e.g., 2+1 for three readers with two agreeing) are common for establishing reference measurements, but the document does not detail this.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study (comparing human readers with and without AI assistance) is generally relevant for AI-powered diagnostic imaging devices, not for a standalone blood pressure monitor.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, the performance described is a standalone (algorithm only) performance. The device itself is an "Automatic Upper Arm Blood Pressure Monitor" which uses an "oscillometric technique" to automatically measure and display blood pressure and pulse rate. The accuracy claims (±3 mmHg for pressure, ±5% for pulse) directly refer to the device's inherent measurement capabilities without human interpretation or intervention in the measurement process itself, beyond proper cuff placement and initiation. The compliance with AAMI SP10 is for the automated device's accuracy.

7. Type of Ground Truth Used

• The ground truth, while not explicitly detailed in its establishment, would inherently be expert consensus or reference measurements as per the requirements of the ANSI/AAMI SP10 standard. This standard often requires comparison of the automated device's readings against simultaneously obtained auscultatory measurements performed by trained observers using a reference method (like a mercury sphygmomanometer).

8. Sample Size for the Training Set

• This information is not applicable or not provided. This device is a traditional oscillometric blood pressure monitor, not an AI/machine learning-driven device in the sense that would require a distinct "training set" for an algorithm. Its operation is based on established physical principles and algorithms for oscillometric waveform analysis, rather than a learned model from a large dataset.

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

• This information is not applicable as there is no mention or indication of a "training set" for an AI algorithm in the provided document for this device.

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