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The Upper Arm Blood pressure Monitor 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 oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm42 cm or 22cm48cm. It is intended to be used in hospital environment or at home.

Upper Arm Blood pressure Monitor (Model:SP10A).

The provided text is an FDA 510(k) clearance letter for an Upper Arm Blood Pressure Monitor, Model SP10A. It primarily addresses the regulatory approval process and includes the device's indications for use.

Crucially, this document does NOT contain information about acceptance criteria, specific study designs (like sample sizes, data provenance, expert qualifications, or multi-reader studies), or the detailed performance metrics of the device against such criteria. It only states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present in the document.
• Sample sizes used for the test set and data provenance: Not detailed.
• Number of experts used to establish ground truth and qualifications: Not detailed.
• Adjudication method: Not detailed.
• MRMC comparative effectiveness study details: Not mentioned. This type of study is more common for AI/imaging devices, not a blood pressure monitor.
• Standalone (algorithm only) performance: Not applicable for this device.
• Type of ground truth used: Not detailed.
• Sample size for the training set: Not detailed.
• How ground truth for the training set was established: Not detailed.

For these details, one would typically need to refer to the full 510(k) submission or supporting clinical validation reports, which are not included in this FDA clearance letter. The letter confirms clearance based on substantial equivalence, but not the detailed study results that led to that determination.

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The Upper Arm Blood pressure Monitor 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 oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.

Upper Arm Blood pressure Monitor, Model SP10A

The provided text is a U.S. FDA 510(k) clearance letter for an "Upper Arm Blood Pressure Monitor, Model SP10A." It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance), or training set information.

Instead, the document primarily focuses on:

• Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: References to applicable regulations (e.g., 21 CFR 870.1130 for noninvasive blood pressure measurement systems), general controls, and other requirements.
• Indications for Use: Describes the intended use of the device for measuring diastolic and systolic blood pressure and pulse rate in adults using an oscillometric technique, for use in hospital or home environments.
• Type of Use: Specifies that it is intended for Over-The-Counter Use.

To answer your request, a different type of document, such as a summary of safety and effectiveness, clinical study report, or specific test results, would be needed. The current document does not provide the detailed performance and study information you're asking for.

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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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This Upper Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.

The Upper Arm Blood Pressure Monitor, including ZK-B869, ZK-B869, ZK-B872 and ZK-B876, can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 32cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and arm cuff. The ZK-B868 is powered by 4 AA dry batteries (DC 6V), other models are powered by 4 AAA dry batteries (DC 6V). The device has a memory function that automatically stores some sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function. The four models have the same intended use, working principle, measuring range, accuracy, cuff, conformance standard; only in appearance and power supply have some difference.

This document describes the 510(k) summary for the "Upper Arm Blood Pressure Monitor" (Models: ZK-B868, ZK-B869, ZK-B872, ZK-B876) by ShenZhen ZhengKang Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to blood pressure measurement accuracy.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

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

The document mentions compliance with the standard ISO 81060-2 (Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type). This standard sets widely accepted accuracy criteria for blood pressure monitors.

While the document doesn't explicitly present a table of acceptance criteria and reported performance in a single table, it states the device "passed" the performance testing according to ISO 81060-2.

The Accuracy section within the comparison table (page 5) lists the following for the targeted device, which are the inherent performance characteristics the device aims to meet:

These values are consistent with the requirements of ISO 81060-2. The statement that the performance testing was "performed to, and passed" these standards implies that the device achieved these accuracies within the limits defined by ISO 81060-2.

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

The document does not provide details on the sample size used for the clinical validation according to ISO 81060-2. It also does not specify the country of origin of the data, nor whether the study was retrospective or prospective.

ISO 81060-2 typically requires a prospective study with a specific number of subjects (usually 85 subjects with specific blood pressure ranges) for clinical validation. However, these specific details are not present in this summary.

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)

For a blood pressure monitor, the "ground truth" (or reference measurement) is typically established by trained observers (often physicians or nurses) using a standardized auscultatory method, with the accuracy verified against a mercury sphygmomanometer or highly accurate validated electronic device.

The document does not specify the number of experts or their specific qualifications used to establish the ground truth for the clinical validation. ISO 81060-2 mandates specific procedures for reference measurements, involving two trained observers, but these details are not stated here.

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

The document does not describe any adjudication method for the test set. For clinical validation of blood pressure monitors, the ISO 81060-2 standard outlines a specific methodology for collecting simultaneous reference measurements from two trained observers, and if there are significant discrepancies, a third observer might be involved. However, this level of detail is not present 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

This section is not applicable to this device. The device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant.

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

The device is inherently a "standalone" automated measurement system. Its performance, as validated against ISO 81060-2, represents its algorithm-only performance in measuring blood pressure and pulse rate. The study is a standalone performance evaluation.

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

The ground truth for blood pressure measurement is established through:

• Simultaneous auscultatory measurements by trained observers using a reference sphygmomanometer (mercury or a highly accurate validated electronic device). This is the standard method prescribed by ISO 81060-2.

While the document doesn't explicitly state "auscultatory measurements," the reference to ISO 81060-2 implies this methodology for ground truth establishment.

8. The sample size for the training set

This device is a hardware product with embedded software/firmware for an established measurement principle (oscillometric). It is not an AI/ML device that undergoes "training" in the typical sense of a deep learning model. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant here, and no information on a training set size is provided.

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

As explained above, there is no "training set" in the AI/ML context for this type of device. The accuracy of the device is assessed through clinical validation against established ground truth measurements from human observers, as per ISO 81060-2, not "trained" on a dataset.

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FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.

FDBP A series Upper Arm Blood Pressure Monitor (Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 )includes utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.

Here's a breakdown 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

Study Proving Acceptance Criteria:

The studies conducted for the FDBP A Series Upper Arm Blood Pressure Monitor are divided into "Non-Clinical Data" and "Clinical Data."

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

• Non-Clinical Data:
  • The document does not explicitly state the sample size for individual biocompatibility, electrical safety, EMC, or bench testing. However, it indicates these tests were conducted on "all the modules and accessories in the system" and "all the patient contracting materials."
  • Data Provenance: Not specified, but given the manufacturer is Famidoc Technology Company Limited (China), it's highly probable the testing was conducted in China or by labs contracted by the Chinese manufacturer. The document doesn't specify if it's retrospective or prospective for non-clinical testing.
• Clinical Data:
  • The document states: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers -Part 2: Clinical validation of automated measurement type."
  • ISO 81060-2: 2013 typically requires a specific number of subjects for clinical validation. While the exact number is not provided in this document, the standard generally mandates a minimum of 85 subjects for validation in a mixed population.
  • Data Provenance: Not explicitly stated, but likely from a clinical study conducted either within China or a region where compliance with ISO 81060-2 is standard. The document doesn't specify if it's retrospective or prospective, but clinical validation studies are inherently prospective.

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

• For the clinical validation (per ISO 81060-2):
  • ISO 81060-2 requires that the reference blood pressure measurements (the "ground truth") be obtained by at least two trained observers using a mercury sphygmomanometer or an equivalent validated reference device.
  • Qualifications of Experts: These observers must be specifically trained and certified to perform accurate auscultatory blood pressure measurements, adhering to strict protocols outlined in the standard. The document does not provide specific details on the individual qualifications of the "two trained observers" used in this particular study, but it is a prerequisite of the standard cited.

4. Adjudication Method for the Test Set:

• For the clinical validation (per ISO 81060-2):
  • The standard dictates a specific methodology where simultaneous (or near-simultaneous) measurements are taken by the device under test and the two trained observers. The average of the two observers' measurements typically serves as the reference (ground truth). Discrepancies between the observers' measurements might trigger re-measurements or specific rules for reconciliation, but a formal "adjudication" in the sense of a third expert resolving disagreements is not always explicitly a primary step unless the initial agreement criteria are not met. The document does not specify the exact adjudication method (e.g., 2+1, 3+1) beyond compliance with ISO 81060-2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:

• Not applicable. This device is an automated blood pressure monitor for direct blood pressure measurement, not an AI-assisted diagnostic imaging device or an interpretation tool involving human "readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of medical device.

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

• Yes, this is a standalone device. The FDBP A Series Upper Arm Blood Pressure Monitor is an automated device designed to measure blood pressure without human intervention in the measurement process (once the cuff is applied and the device activated). The "algorithm only" performance is the core function of such a device. The clinical validation conducted under ISO 81060-2 is precisely a standalone performance evaluation against a human-read auscultatory reference.

7. The Type of Ground Truth Used:

• Expert Consensus (Auscultatory Reference): For the clinical validation, the ground truth for blood pressure measurements is established by trained human observers using the auscultatory method (typically with a mercury sphygmomanometer or a validated equivalent), following the protocols defined in ISO 81060-2. This is considered an "expert consensus" in the context of blood pressure measurement.

8. The Sample Size for the Training Set:

• Not applicable/Not explicitly stated. As an automated blood pressure monitor, the device's core functionality relies on a pre-defined oscillometric algorithm rather than a "training set" in the context of machine learning or AI models. While the algorithm itself would have been developed and refined using data (which could be loosely considered "training"), the document does not provide details on such a training dataset or its size. The primary validation focuses on its clinical performance against expert-derived ground truth.

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

• Not applicable/Not explicitly stated. Similar to point 8, the document does not detail a "training set" for an AI algorithm. If an algorithm development process involved data, the ground truth for that development would likely have been established through a combination of simulated data, data from calibration devices, and potentially earlier validation studies against auscultatory measurements. However, the document does not provide these specifics.

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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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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches (22cm to 42cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Evolv Model BP7000 Upper Arm Blood Pressure Monitor ("BP7000") is a battery powered automatic non-invasive blood pressure system intended for home use. The device inflates a cuff with an integral controllable pump, then deflates the cuff via an electric valve. During inflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/min. BP7000 is intended to be used for arms ranging from 22 to 42cm in circumference. The cuff is not replaceable. The device also detects the appearance of irregular heartbeats during measurement. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. The operation of the device is intended for home use. Functions and other features that are controlled by the end user include applying the arm cuff to the upper arm, powering on/off the system, starting or stopping the BP and pulse measurement cycle, and installing and changing the batteries as needed. As an optional feature, the user can also pair the BP7000 to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, BP7000 does not connect with other collateral devices.

The provided text describes the 510(k) submission for the Omron Evolv Model BP7000 Upper Arm Blood Pressure Monitor. This device is a non-invasive blood pressure measurement system, and the submission focuses on demonstrating its substantial equivalence to a predicate device (Omron HEM-7320) rather than proving performance against specific acceptance criteria for an AI/ML powered device.

Therefore, many of the requested details regarding AI/ML study methodologies (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this traditional medical device submission.

However, I can extract the relevant information regarding the device's performance and the clinical testing that was conducted.

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

Acceptance Criteria and Study for Omron Evolv Model BP7000 Upper Arm Blood Pressure Monitor

This submission demonstrates substantial equivalence of a traditional blood pressure monitor to a predicate device, not the performance of an AI/ML algorithm. As such, many of the requested AI/ML specific criteria are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are primarily based on demonstrating equivalence to the predicate device and meeting established industry standards for blood pressure monitors. The document mentions an accuracy claim for both the proposed and predicate devices.

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

• Test Set Sample Size: The document does not explicitly state the exact sample size for the clinical investigation. It mentions "a clinical investigation" to validate accuracy. For non-clinical bench testing, it refers to "comparative blood pressure and pulse rate testing to the predicate device" and "performance verification testing," but no specific sample numbers are provided.
• Data Provenance: Not explicitly stated regarding country of origin. The clinical investigation was for "validating the accuracy... as compared to an auscultation method." It does not specify if it was retrospective or prospective, but clinical investigations for device validation are typically prospective studies.

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

• Number of Experts: Not explicitly stated. The clinical investigation compared the device's accuracy "to an auscultation method using a calibrated sphygmomanometer by trained medical staff."
• Qualifications of Experts: "Trained medical staff." No further details on their specific qualifications or experience level (e.g., radiologist with X years of experience) are provided as this is not an imaging device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not stated. The comparison was to an auscultation method performed by medical staff, implying a direct comparison rather than an expert consensus adjudication process typically seen in image interpretation studies.

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

• MRMC Study: Not applicable. This is a blood pressure monitor, not an AI-powered diagnostic tool requiring human reader studies.

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

• Standalone Performance: The device itself performs the measurement and provides readings. The "clinical investigation" effectively evaluates its "standalone" performance against a reference standard (auscultation). The direct comparison was of the device's measured blood pressure values against the auscultation readings.

7. The Type of Ground Truth Used

• Ground Truth: For the clinical investigation, the ground truth was based on the auscultation method using a calibrated sphygmomanometer performed by trained medical staff. This serves as the clinical reference standard.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a traditional blood pressure monitor, not an AI/ML algorithm that undergoes a distinct "training" phase with a specified dataset. Its internal algorithm for oscillometric measurement is pre-defined.

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

• Ground Truth Establishment for Training Set: Not applicable. As stated above, this is not an AI/ML device in the context of "training data." The device's underlying algorithm for converting oscillometric data to blood pressure readings is based on established physiological principles and engineering design, not on a machine learning training process with a labeled dataset.

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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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