(133 days)
Upper Arm Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).
The Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN operation is based on the oscillometric method. This method takes advantage of the pressure pulsations taken during measurements. An occluding cuff is placed on the left arm and is connected to an air pump and a pressure sensor. The cuff is inflated until a pressure higher than the typical systolic value is reached, then the cuff is slowly deflated. As the cuff deflates, when systolic pressure value approaches, pulsations start to appear. These pulsations represent the pressure changes due to heart ventricle contraction and can be used to calculate the heartbeat rate. Pulsations grow in amplitude until mean arterial pressure (MAP) is reached, then decrease until they disappear. The blood pressure information is displayed as digital information on the device's screen.
The provided text is related to a 510(k) premarket notification for an Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN. The document describes the device, compares it to a predicate device, and outlines the testing conducted to support its substantial equivalence.
However, the request asks for specific details about acceptance criteria and a study that proves the device meets the acceptance criteria, particularly in the context of an AI/ML medical device. The provided document is for a traditional medical device (blood pressure monitor) and does not contain information about AI/ML acceptance criteria or an AI-based study. It focuses on performance standards (like IEC 80601-2-30) for blood pressure measurement accuracy, not AI performance metrics.
Therefore, I cannot fulfill the request as it asks for information (AI acceptance criteria, AI study details, expert ground truth, MRMC study, etc.) that is not present in the provided document. The document describes non-clinical and performance testing for a standard blood pressure monitor.
To directly answer the prompt and explain why I cannot provide the requested information, here's a breakdown of what is and is not in the text:
Information Present in the Document:
- Device Name: Upper Arm Electronic Blood Pressure Monitor, Model BM100-EN
- Predicate Device: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE670D (K170605)
- Indication for Use: Measuring blood pressure and pulse rate of adults at household or medical center (not for neonate, pregnancy, or pre-eclampsia).
- Measurement Method: Non-invasive, oscillometric.
- Performance Standards Met: IEC 80601-2-30 (Medical electrical equipment Part 2-30: Particular Performance requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) and ISO 81060-2 (Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type).
- Accuracy Claims (from characteristics table): Blood Pressure Range Accuracy: ±3 mmHg (±0.4kPa); Pulse Rate Measurement Accuracy: ±5% of reading value.
- Non-Clinical Testing: Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11), Software Verification and Validation (following FDA Guidance for moderate level of concern software), Cleaning Validation, Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10).
- Clinical Study: "a comparative clinical study to verify the performance of the subject device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2:2013." This is a study to validate the accuracy of the blood pressure readings against a reference, not an AI performance study.
Information Not Present in the Document (and thus, cannot be provided to answer your specific questions about AI/ML acceptance criteria and studies):
- Table of AI acceptance criteria and reported device performance: The document lists performance criteria for a blood pressure monitor (e.g., accuracy ±3 mmHg) but not AI-specific metrics like sensitivity, specificity, AUC, F1-score, etc.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): While a "comparative clinical study" is mentioned, no details about sample size (number of subjects), data provenance, or whether it was retrospective/prospective are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is for a blood pressure monitor, not an AI image interpretation device. Ground truth for blood pressure is typically established by direct measurement with a reference standard (like a mercury sphygmomanometer) in a clinical setting.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable for this device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical measurement device, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure, the ground truth is often the reading from a validated reference device (e.g., mercury sphygmomanometer) or invasive arterial pressure. The document mentions comparison to a mercury sphygmomanometer.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set in that context.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided FDA 510(k) clearance document is for a basic medical device (blood pressure monitor) and does not describe an AI/ML device or its associated acceptance criteria and validation studies as detailed in your query.
§ 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).