(79 days)
The K-jump's SmartlogiC models KP-6210 and KP-6211 are intended to be used for the measurement of the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff that is wrapped around the wrist. The devices are indicated for use in adults.
The devices are electronic blood pressure monitors with LCD displays. The devices were designed to measure the blood pressure of the systolic, diastolic, and pulse rate by using an inflating cuff.
Here's an analysis of the provided text regarding the acceptance criteria and study for the K-jump's Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Measurement Accuracy | Compliance with AAMI/ANSI SP10A-1996 standard | Complies with AAMI/ANSI SP10A-1996 in its entirety. |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2 (1993) | Complies with EN 60601-1-2 (1993) |
| Electromagnetic Interference (EMI) | CISPR11 (1993) Class B | Complies with CISPR11 (1993) Class B |
| Electrostatic Discharge (ESD) Immunity | IEC 801-2 (1991) | Complies with IEC 801-2 (1991) |
| Radiated/Conducted RF Immunity | IEC 801-3 (1984) | Complies with IEC 801-3 (1984) |
2. Sample Size for Test Set and Data Provenance
The provided text does not explicitly state the sample size used for testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). It only states that the devices comply with the AAMI/ANSI SP10A-1996 standard, which itself outlines testing protocols and sample size recommendations for blood pressure monitors.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set. For blood pressure devices, the "ground truth" for accuracy is typically derived from comparison with a highly accurate reference method, such as invasive arterial blood pressure measurement or auscultatory measurement by trained observers using a mercury sphygmomanometer, as specified by standards like AAMI/ANSI SP10.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set, as it does not rely on human interpretation of subjective data requiring consensus. For blood pressure monitors, accuracy is objectively measured against a reference standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is typically relevant for interpretative devices (e.g., imaging devices) where human readers' performance is influenced by the device's output. Blood pressure monitors provide quantitative readings directly.
6. Standalone (Algorithm Only) Performance Study
The information provided indicates that the study performed was a standalone (algorithm only) performance study in the sense that the device's measurements were evaluated directly against recognized standards. There isn't a human-in-the-loop component for the measurement itself, though a human operates the device. The compliance with AAMI/ANSI SP10A-1996 is a direct assessment of the device's accuracy.
7. Type of Ground Truth Used
The ground truth used for verifying the device's performance is compliance with the AAMI/ANSI SP10A-1996 standard. This standard outlines the methodology for clinical validation of automated sphygmomanometers, which typically involves comparing the device's readings against simultaneous auscultatory measurements by trained observers or an invasive reference method. Therefore, the ground truth is based on a reference standard measurement by trained personnel, not expert consensus, pathology, or outcomes data in the usual sense.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is because the device is not based on a machine learning algorithm that requires a separate training phase to learn patterns from data. It's a deterministic device that measures physical parameters.
9. How Ground Truth for the Training Set Was Established
As there is no explicit training set for a machine learning model, the concept of establishing ground truth for a training set is not applicable in this context. The device's operation is based on established principles of oscillometric blood pressure measurement.
§ 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).