(121 days)
The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.
The Arm BPM is designed to measure the systolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the upper arm and held in place with Velcro™, a LCD display, a semiconductor sensor, an internal air pump, a battery power or AC/DC power source, and keys for operation.
The provided document is a 510(k) summary for the K-jump Arm Blood Pressure Monitor, Models KP-6821A and KP-6822A. It describes the device's intended use and technological characteristics, and references conformity to EN60601-1 (LVD test) in addition to the predicate device's standards. However, it does not contain detailed information regarding specific acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance data.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a breakdown of what can be reported and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "In addition to the conformity standards of the predicate device, this Arm BPM also complies with EN60601-1 (LVD test)." It does not provide specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or actual device performance values against such criteria. EN60601-1 is a general standard for the safety of medical electrical equipment, not specifically for blood pressure measurement accuracy.
Therefore, a table cannot be populated as requested.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitors, ground truth typically comes from reference sphygmomanometers operated by trained personnel, not necessarily "experts" in the same way as medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
MRMC studies and AI assistance are not relevant to this type of device (a blood pressure monitor). This information is not provided and would not be expected for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone blood pressure monitor. Performance tests would inherently be "standalone" in the sense that the device measures blood pressure without continuous human interpretation of its output in a diagnostic context. However, the details of such performance tests are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The specific method for establishing ground truth for blood pressure measurements is not explicitly stated, but it would typically involve comparison to readings from a validated reference sphygmomanometer (e.g., mercurial or oscillometric) operated by trained individuals, following established protocols (e.g., AAMI or ISO standards).
8. The sample size for the training set
This information is not provided in the document. Blood pressure monitors typically do not involve statistical "training sets" in the same way machine learning algorithms do; their calibration and validation are based on comparison to reference devices.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 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).