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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.

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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.

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