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510(k) Data Aggregation
(418 days)
Wrist Electronic Sphygmomanometer
Wrist Electronic Sphygmomanometer is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
The Wrist Electronic Sphygmomanometer 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 wrist within its claimed range and accuracy via the oscillometric technique.
The device uses the oscillometric method to determine blood pressure. This is accomplished by means of a sensitive transducer, which measures cuff pressure and minute pressure oscillations within the cuff. The first determination sequence initially pumps up to a cuff pressure of about 180-230mmHg for adults. After inflating the cuff, the Wrist Electronic Sphygmomanometer begins to deflate it at a rate of 3-6 mmHq/sec, and measures systolic, mean, and diastolic pressure. The Wrist Electronic Sphygmomanometer deflates the cuff one step each time it detects two pulsations of relatively equal amplitude ("peak matching"). The time between deflation steps depends on the frequency of these matched pulses (pulse rate of the patient). However, if the Wrist Electronic Sphygmomanometer is unable to find any pulse within several seconds, it will deflate to the process of finding two matched pulses at each step provides artifact rejection due to patient movement and greatly enhances accuracy.
The device will obtain the pressure point, which is before the maximum peak and whose amplitude of peak is 0.45 times the reference amplitude, is determined to be the systolic pressure; and the pressure point, which is after the maximum peak and whose amplitude of peak is 0.75 times the reference amplitude, is determine to be the diastolic. When the diastolic pressure has been determined, the NIBP Meter finishes deflating the cuff and updates the screen.
The provided document describes the Wrist Electronic Sphygmomanometer (models CK-101, CK-101S, CK-102S, CK-W118, CK-W132, CK-W133, CK-W135, CK-W175, CK-W176, CK-W355, CK-W356, CK-W358) and its substantial equivalence to a predicate device, the Med-link Wrist Digital Blood Pressure Monitor (Model: ESM101). The primary study proving the device meets acceptance criteria appears to be a performance evaluation according to the AAMI / ANSI / ISO 81060-2 standard, which is a standard for non-invasive blood pressure monitors.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document largely details equivalence to a predicate device rather than precise acceptance criteria and specific performance numbers for the subject device beyond the general range and accuracy claims. However, the performance specifications listed for the subject device can be inferred as its reported performance, and by extension, the acceptance criteria as meeting these specifications (and demonstrating equivalence to the predicate which also meets these).
| Acceptance Criteria / Specification | Reported Device Performance (Subject Device) |
|---|---|
| Measuring Pressure Range | 0~299mmHg |
| Measuring Pulse Range | 40~199 times/min |
| Pressure Resolution | 1 mmHg or 0.1kPa |
| Measuring Pressure Accuracy | ± 3mmHg |
| Measuring Pulse Accuracy | ±5% |
| Cuff Circumference | 13.5-19.5 cm |
| Inflation and Deflation | Automatic |
| Measuring Method | Non-invasive Oscillometric |
| Patient Population | Adult |
| Display | LCD |
| Operation Temperature | +5 to +40 °C |
| Operation Humidity | 15 to 90% |
| Operation Atmospheric Pressure | 80 kPa~106 kPa |
| Transport/Storage Temperature | -25°C to +70°C |
| Transport/Storage Humidity | ≤93%R.H. |
| Transport/Storage Atmospheric Pressure | 70 kPa~106 kPa |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30 |
| EMC Standards Compliance | IEC 60601-1-2 |
| Biocompatibility Standards Compliance | ISO 10993 series |
The document notes that the device "meets the requirements as safety and performance standards required," implying that its performance aligns with what is expected by relevant standards like AAMI / ANSI / ISO 81060-2.
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Performance according to AAMI / ANSI / ISO 81060-2 standard" was conducted. This standard typically specifies requirements for clinical validation, often involving a certain number of subjects. However, the exact sample size used for the test set (clinical validation cohort) is not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide this information. For a blood pressure monitor, ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a reference device, not necessarily "experts" in the context of image interpretation. The ISO 81060-2 standard outlines procedures for obtaining reference blood pressure measurements.
4. Adjudication Method for the Test Set
The document does not provide this information. For blood pressure device validation, adjudication usually refers to how discrepancies between multiple reference measurements are handled, which is part of the ISO 81060-2 methodology but not detailed here.
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 (N/A). This device is a non-invasive blood pressure measurement system and not an AI-assisted diagnostic tool that would involve human readers or image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The performance evaluation according to AAMI / ANSI / ISO 81060-2 is inherently a standalone performance study of the device, as it evaluates the algorithm's accuracy in measuring blood pressure compared to a reference standard without human intervention in the measurement process (though humans apply the device and record results).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For blood pressure monitoring devices, the ground truth is established through simultaneous measurements using a validated reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer as per AAMI/ISO standards). The document states "Performance according to AAMI / ANSI / ISO 81060-2 standard," which defines how this ground truth is established.
8. The Sample Size for the Training Set
The document does not provide this information. Blood pressure monitors typically do not have a "training set" in the machine learning sense. The device's algorithm is developed based on physiological principles and validated against clinical data.
9. How the Ground Truth for the Training Set Was Established
The document does not provide this information. As mentioned above, the concept of a "training set" with established ground truth is not typically relevant for this type of medical device in the same way it would be for an AI/ML algorithm. The underlying oscillometric algorithm is based on established scientific principles and previously collected physiological data, but not usually in a "training set" context as defined for AI.
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