(74 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 arm. The device is indicated for use in adults.
The K-Jump Arm Blood Pressure Monitor, Model KP-6821 AND KP-6822 are 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, diastolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the arm and held in place with Velcro™, an LCD display, a semiconductor sensor, an internal air pump, a battery power source, and keys for operation.
Here's a breakdown of the acceptance criteria and study details for the K-Jump Arm Blood Pressure Monitor, Models KP-6821 and KP-6822:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on compliance with standards rather than specific numerical performance metrics. The key standard referenced is ANSI/AAMI SP10A-1996. While the text states the device "complies" with this standard, it does not explicitly list the numerical acceptance criteria from that standard or specific numerical results for K-Jump's device beyond "tested with."
Therefore, based only on the provided text:
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10A-1996 "Electronic or Automatic Sphygmomanometer" | Complies with the standard. |
To provide a complete table with numerical acceptance criteria, one would need to refer to the ANSI/AAMI SP10A-1996 standard itself. Generally, this standard specifies accuracy requirements such as:
- Mean difference: The mean difference between the device readings and reference readings (e.g., mercurial sphygmomanometer) should be within ±5 mmHg.
- Standard deviation: The standard deviation of the differences should be 8 mmHg or less.
However, since these specific numerical values are not in the provided text, they are not included in the table above.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: One hundred patients.
- Data Provenance: The text does not specify the country of origin of the data. It also does not explicitly state whether it was retrospective or prospective, but clinical trials are generally prospective. Given the nature of a clinical trial for device validation, it is highly likely to be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The text states that the blood pressure and heart rate were "tested with both an Ausculatory Mercurial Sphygmomanometer and the Arm BPM." The mercurial sphygmomanometer is the reference standard (ground truth). It is implied that a trained human operator (likely a medical professional) would be performing the auscultatory measurements. However:
- Number of Experts: Not specified. It's typically one per patient measurement for the reference, but the text doesn't indicate if multiple independent experts were involved for comparison purposes on the same patient.
- Qualifications of Experts: Not explicitly stated. For auscultatory measurements using a mercurial sphygmomanometer, the operator would need to be trained in proper blood pressure measurement techniques (e.g., a nurse, physician, or trained technician).
4. Adjudication Method for the Test Set
The text describes a direct comparison: "One hundred patients had their blood pressure and heart rate tested with both an Ausculatory Mercurial Sphygmomanometer and the Arm BPM." This implies a comparison between the device's reading and the singular reading from the reference standard. There is no mention of multiple expert readings that would require an adjudication method (like 2+1 or 3+1 concensus).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This was not an MRMC comparative effectiveness study. The study described compares a device's performance to a reference standard, not the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes. The study described is a standalone performance test of the Arm BPM device against a reference standard. The device operates automatically to measure blood pressure and heart rate.
7. The Type of Ground Truth Used
- Expert Reference Standard: The ground truth was established by an "Ausculatory Mercurial Sphygmomanometer." This is considered the clinical gold standard for non-invasive blood pressure measurement, requiring a trained human operator (expert) for its use.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. The document describes the validation study (test set) for regulatory submission. It does not provide information about a "training set" for an algorithm. Blood pressure monitors like this typically rely on established physiological principles and signal processing, rather than machine learning models that require a separate training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As no training set information is given, this question is not relevant based on the provided text.
§ 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).