(121 days)
The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm and 40cm-56cm.
The Arm-type Blood Pressure Monitor (BPM) series is an automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The systolic and diastolic pressures are determined using the Oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats per minute.
The DBP-6286B embed bluetooth module to transfer data to APP. With the use of software (including APP) and Bluetooth communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (issued on September 28, 2022.), this software function is belong to Non-device-MDDS.
Based on the provided FDA 510(k) clearance letter for the JOYTECH Healthcare Co., Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186), here's a description of the acceptance criteria and the study proving the device meets them:
Acceptance Criteria and Device Performance for Blood Pressure Monitors
The acceptance criteria for blood pressure monitors are typically defined by recognized international standards, primarily ISO 81060-2:2018+AMD2020, which pertains to the clinical investigation of intermittent automated measurement type for non-invasive sphygmomanometers. This standard specifies the accuracy requirements for blood pressure measurements.
The key acceptance criterion is that the accuracy of the blood pressure monitor must be within the acceptable scope specified in ISO 81060-2:2018+AMD2020. While the exact numerical thresholds for group means and standard deviations aren't explicitly stated in this clearance letter, the general requirement is clear.
The reported device performance confirms that the device meets these criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy (Systolic and Diastolic) within acceptable scope of ISO 81060-2:2018+AMD2020 | For cuff with arm circumference 22-42cm: The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020. This was covered by a representative study on DBP-6279B, which shares the same key factors (principle, measurement type, core algorithm, pressure sensor, MCU, cuff size, and material) affecting clinical accuracy. |
| Blood Pressure Accuracy (Systolic and Diastolic) within acceptable scope of ISO 81060-2:2018+AMD2020 | For cuff with arm circumference 40-56cm: The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020. This was demonstrated by a study on DBP-6286B. |
Study Details Proving Device Meets Acceptance Criteria:
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A table of acceptance criteria and the reported device performance: (See table above)
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Sample sizes used for the test set and the data provenance:
- Cuff (22-42cm): 91 valid subjects' data were used for analysis.
- Cuff (40-56cm): 85 valid subjects' data were used for analysis.
- Data Provenance: The document does not explicitly state the country of origin of the data, but it implies a prospective clinical study ("All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies the use of human observers for the reference measurements, as it states: "The manual Mercury Sphygmomanometer was used as a reference device." This suggests that the ground truth was established by human operators taking readings from a mercury sphygmomanometer against which the automated device's readings were compared. However, the exact number and qualifications of these "experts" (human observers) are not specified in the provided document.
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Adjudication method for the test set:
- The document states, "Same arm sequential method was adopted during clinical testing." This method involves comparing simultaneous or near-simultaneous measurements from the test device and a reference device on the same arm. While this describes the measurement procedure, it does not describe an adjudication method for discrepancies between readings, as would be typical for expert consensus. Given that the ground truth is a direct measurement from a mercury sphygmomanometer, an adjudication process in the traditional sense (e.g., for image interpretation) is not directly applicable.
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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. This is a medical device clearance for a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant and were not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study design (clinical validation against a reference standard) inherently evaluates the "standalone" performance of the automated blood pressure monitor's algorithm. The device itself is designed to operate without continuous human intervention during the measurement process, making its performance essentially "algorithm only" in terms of blood pressure determination from the oscillometric data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by direct measurement using a manual Mercury Sphygmomanometer. This is considered the clinical gold standard for non-invasive blood pressure measurement in this context.
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The sample size for the training set:
- The document does not specify a separate training set or its sample size. For traditional medical devices like blood pressure monitors, the "training" (development and calibration) often occurs during the device engineering and manufacturing phases, and clinical validation is then performed on a separate, independent test set as described.
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How the ground truth for the training set was established:
- As no specific "training set" is mentioned in the context of a separate clinical dataset, the method for establishing ground truth for such a set is not provided. The device's underlying algorithms would have been developed and refined through engineering and calibration processes, likely using extensive internal testing and validation against standardized pressure sources and reference measurements, rather than a distinct "clinical training set" in the AI/ML sense.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).