Search Results

The BPBIO750 is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with left and right upper arm circumference ranging from 22 cm (8.7-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method. The BPBIO750 may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension.

The InBody BPBIO750 is a kiosk-type, automated, single upper-arm cuff oscillometric BP monitor developed for self-measurement of BP in public spaces. It is designed for BP measurements on either the right or left upper arm and has a fixed tubular opening to insert the user's arm, with an integral single-arm cuff, which when inflated surrounds the upper arm. It is suitable for arm circumference range 22-42 cm. The device has an elbow groove to ensure correct positioning of the arm and measures BP during inflation. A wide LED screen presents systolic and diastolic BP, heart rate and time of measurement, and print-out of these data is provided automatically to the user. When the device is turned on, an auto zero calibration is performed, as well as a functional self-check of the air pressure change according to motor operation, the initial cuff position, and the motor load according to the cuff movement. Its weight is 7.1 kg, width 299 mm, depth 547 mm, height 485 mm, and has power supply through cable (AC 250 V, 10A). Calibration is recommended once every 12 months.

The InBody BPBIO750 is a digital monitor intended for measuring blood pressure and pulse rate. The information below details the acceptance criteria and the study proving the device meets these criteria, as derived from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).

Conclusion: The InBody BPBIO750 device fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in the general population.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 102 subjects were recruited, and 85 were analyzed for the test set.
• Data Provenance: The text does not explicitly state the country of origin for the data. The study was conducted retrospectively or prospectively as "Subjects were recruited to fulfil the age, gender, BP and cuff distribution criteria of the AAM/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method." This indicates a prospective clinical study design.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not specify the number of experts or their qualifications for establishing the ground truth for the test set. It mentions "reference BP readings", implying a standard, accurate measurement method was used, but does not detail the personnel involved in generating these reference readings.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The study design followed the "same arm sequential BP measurement method" according to the AAMI/ESH/ISO Universal Standard, which implies direct comparison to a reference measurement rather than multi-reader adjudication of subjective interpretations.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the accuracy of the device itself against a reference standard, not on how human readers' performance might improve with or without AI assistance.

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

Yes, a standalone performance study was done. The study aimed to evaluate the accuracy of the InBody BPBIO750, which is an automated oscillometric BP monitor, in measuring blood pressure against established standards. The reported metrics (mean differences and standard deviations) reflect the device's inherent accuracy without human interpretation or intervention in the measurement process.

7. Type of Ground Truth Used

The ground truth used was expert consensus / reference blood pressure readings. The study design refers to "differences between the test device and reference BP readings," implying that highly accurate, validated blood pressure measurements served as the ground truth against which the device's performance was compared. This is typical for blood pressure device validation, where the reference is often obtained using a highly accurate, often invasive or a validated auscultatory method by trained personnel.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. As this is a medical device (blood pressure monitor) and not an AI/ML diagnostic system in the typical sense, there isn't an explicitly separate "training set" described in the provided context for algorithmic learning. The device's underlying algorithm is based on oscillometric principles, which are well-established and not typically "trained" on large datasets in the way modern AI models are. The testing described is validation of its accuracy.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" is mentioned for the device's core functionality (see point 8), the document does not describe how ground truth for a training set was established.

Ask a specific question about this device

This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 42 cm.

The BPBIO480KV is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with upper arm circumference ranging from 22cm (8.6-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The BPBIO480KV may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Warnings and cautions described in the user's manual should be observed at all times. Automated Auscultation is a method that combines the accuracy of auscultation, and the convenience of the Oscillometric method. To measure the blood pressure, wrap the cuff around the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the air to detect the Korotkoff sound signal and the pressure sensor signal, which you can listen with the stethoscope attached to the cuff, to measure the systolic and diastolic blood pressure. The Automated Auscultation applied to BPBIO480KV combines the accuracy of the auscultation method with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement. Included components are the main unit, a large and a medium size cuff, a users manual, an AC adapter, a power cord, and an internal rechargeable lithium rechargeable battery. Measurement methods: Auscultation and Oscillometric.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BPBIO480KV device:

Acceptance Criteria and Device Performance

Note: The text explicitly states these accuracy metrics as both "Accuracy" in the comparison table and also references conformity to ISO 81060-2:2018, which sets similar accuracy requirements. The "Validation Results" section states: "The system passed the deviation limits initially set by the protocol," which implies these criteria were met.

Study Details

1. Sample Size for Test Set and Data Provenance:

   • Sample Size: 85 total subjects (also stated as "among 93 participants" for both cuff sizes). This discrepancy might refer to 85 subjects contributing to the core data and 93 participants being enrolled to test both cuff sizes. Given the context of ISO 81060-2, a typical minimum sample size for validation is around 85 for a general population.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the mention of "European Society of Hypertension recommendations" and "ISO 14155:2020 principles for Good Clinical Practice" suggests a prospective clinical investigation.

2. Number of Experts and Qualifications for Ground Truth:

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: Not explicitly stated. However, ISO 81060-2:2018 implicitly requires trained observers (auscultators) for reference measurements. The text mentions "medical staffs hear directly" when describing the auscultation method, implying human expert involvement in establishing ground truth.

3. Adjudication Method for Test Set:

   • Adjudication Method: Not explicitly stated. The description mentions "A 'V' tube was used to connect both the automated meter and the standard mercury sphygmomanometer to the cuff." This standard methodology for blood pressure validation typically involves simultaneous measurements by the device under test and human observers using a reference method (mercury sphygmomanometer and stethoscope), with statistical analysis of the differences. It doesn't explicitly describe an adjudication process for discrepancies between human observers, but ISO 81060-2:2018 often details such procedures (e.g., blinded observers, averaging, or a third arbitrator).

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

   • No, a MRMC comparative effectiveness study was not reported. The study focused on the standalone accuracy of the device against a reference standard, not its impact on human reader performance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

   • Yes, a standalone performance study was conducted. The "Clinical Testing" section describes measuring the BPBIO480KV's performance against a reference standard (mercury sphygmomanometer) using a "V" tube setup, which is a direct validation of the device's accuracy.

6. Type of Ground Truth Used:

   • Expert Consensus / Reference Standard Measurement: The ground truth was established by simultaneous measurements using a "standard mercury sphygmomanometer" and presumably auscultation by human observers, which is considered the gold standard for non-invasive blood pressure measurement in such validation studies.

7. Sample Size for Training Set:

   • Not explicitly stated. The document focuses on the validation study (clinical testing), not the development or training process of the device's algorithms.

8. How Ground Truth for Training Set Was Established:

   • Not explicitly stated. As with the training set size, the document does not elaborate on the development phase or how any internal algorithms were trained. The focus is solely on the validation demonstrating the device's accuracy against recognized standards.

Ask a specific question about this device

The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.

This device can be used to measure blood pressure and pulse rate non-persistently using the Korotkoff sound method of measuring blood pressure in vitro. The user can measure the blood pressure using this device and cuff, stethoscope. Basically, it has the same function as a conventional mercury sphygmomanometer. However, instead of using harmful mercury to the human body, it displays the pressure on the LCD screen, so that the blood pressure can be measured harmlessly to the human body. In addition, using the 'Mark' function can conveniently display the systolic and diastolic pressures. And using its backlight, the user can measure blood pressure in the dark place. If air pressure exceeds 320mmHg, it will automatically exhaust quickly. If an emergency occurs during the measurement, pressing On/Off button will turn off the equipment and allow rapid exhaust. The device is for use by medical professional. The testing person supplies their own stethoscope, which is required for making the measurements.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 102 subjects
• Data Provenance: Not explicitly stated, but the study was performed by InBody, implying internal testing. The documentation does not specify the country of origin of the data.
• Retrospective/Prospective: Not explicitly stated, but given it's a bench testing procedure to verify accuracy, it would typically be a prospective study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The document states "using the stethoscope," implying trained individuals capable of listening for Korotkoff sounds. However, no specific qualifications (e.g., radiologist, years of experience) are provided for these individuals.

4. Adjudication Method

• Adjudication Method: Not applicable/not specified. The ground truth was established by comparing the device's readings to the manual method of measuring blood pressure using a mercury manometer and a stethoscope. This is a direct comparison rather than an adjudication of multiple expert opinions.

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

• MRMC Study Done? No. The document describes a bench test comparing the device to a manual method, not an MRMC study assessing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Standalone Study Done? Yes. The study focused on the accuracy of the BPBIO210/220/210T/220T device itself in comparison to the manual method using a mercury manometer and a stethoscope. This evaluates the algorithm's performance (or in this case, the device's accuracy as a measurement tool for manually read Korotkoff sounds) independent of human interpretation biases beyond the initial listening.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by direct comparison to a manual method of measuring blood pressure using a mercury manometer and a stethoscope, which is considered the gold standard for this type of device.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The device is a manual blood pressure monitor that uses the Korotkoff sound method. It is not an AI/algorithm-driven device in the sense of requiring a "training set" for machine learning. The "bench testing" described is for validation and verification, not for training a model.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no "training set" for a machine learning model. The device's operation relies on a physical process and the user's ability to interpret Korotkoff sounds.

Ask a specific question about this device

The Inbody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm.

The models of BP170, BP160 and BP160B are designated as both Prescription use and Over-the-counter use.

The model of BPBIO250 is designated as Prescription use only.

All models have this common feature: Automatic blood pressure measurement using the oscillometric technique. This is the same method as our predicate. We have employed essentially the same technology as we used in our previous model (the predicate) but have packaged the unit differently in order to make it more portable. Instead of having a built in blood pressure cuff, we have moved that component outside of the unit so that now it plugs in to the measurement unit in the same way a large number of similar devices are designed. Instead of AC line operation only, the units can run on primary or on rechargeable batteries. The predicate device used an 8 bit microcontroller with 128Kbytes of in-system programmable flash memory. The BP170 series and the BPBIO250 use 32 bit microcontrollers with 128Kbytes of programmable flash. Most of the measurement software has been re-used from our predicate device and is virtually the same between the two new sets of models.

The BP170 is a fully automatic portable battery operated blood pressure monitor using the oscillometric technique which comes with batteries, a standard cuff, a storage pouch, and a user's manual.

BPBIO250 This product is a professional automatic blood pressure monitor used by medical professionals. 5 measurement modes can be selected according to various medical environments. Rechargeable batteries can be used without replacing batteries. The User can measure blood pressure even in dark environments. - This blood pressure monitor has cuffs of various sizes. So, User can measure the blood pressure and measure pulse rate to children and adult patients whose arm circumferences are between 17 cm and 42 cm.

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

Acceptance Criteria and Reported Device Performance

Study Details

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

   • BP170 Series: 106 subjects
   • BPBIO250: 104 subjects with 312 observations
   • 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 "Separate clinical investigations were performed". Given it's a 510(k) submission for a new medical device, clinical studies are typically prospective.

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

   • The document states that the comparison was to "manual blood pressure measurement". This implies human observers. However, it does not specify the number of experts, their qualifications, or how many were involved in establishing the ground truth (e.g., if multiple readings were taken and averaged). The implicit standard for manual blood pressure measurement would be trained medical professionals using a mercury manometer and stethoscope.

3. Adjudication Method for the Test Set:

   • The document implies a direct comparison between the device's measurement and a manual blood pressure measurement (using a mercury manometer and stethoscope). It does not describe any specific adjudication method among multiple manual readers (e.g., 2+1, 3+1).

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This study focused on the accuracy of the device against a gold standard (manual measurement), not on how humans using AI assistance improve their performance.

5. Standalone Performance:

   • Yes, a standalone performance study was done. The study directly compared the accuracy of the automated Non-Invasive Blood Pressure (NIBP) monitor (the algorithm/device) against a manual blood pressure measurement (the ground truth).

6. Type of Ground Truth Used:

   • Expert Consensus (Implicit): The ground truth was established by "manual blood pressure measurement" using a mercury manometer and stethoscope. While not explicitly stated as "expert consensus," this method inherently relies on trained human observers performing the measurement, which can be considered an expert-derived ground truth. The text states: “InBody has compared the accuracy between mercury manometer using the stethoscope and the non-invasive automatic sphygmomanometers.”

7. Sample Size for the Training Set:

   • The document does not provide details about a specific training set for the device's algorithm. It focuses on the clinical testing for regulatory clearance. Given that the software "Most of the measurement software has been re-used from our predicate device," it's likely previous data or general engineering principles informed the algorithm, rather than a specific, new training set for these models.

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

   • As no specific training set is mentioned for these new models, the method for establishing its ground truth is not described. The re-use of software from a predicate device suggests that the core algorithm was developed and validated previously.

Ask a specific question about this device