(55 days)
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD PANEL.
One or two readings will not provide a true indication of your normal blood Ghe of the is very important to take regular, daily measurements and to keep prood. I would be and home. (Try to measure your blood pressure at the same time each day for consistency). In partnership with your doctor, an accurate record of your blood pressure over a period of time can be a valuable aid in diagnosing and preventing potential health problems.
Not Found
This 510(k) summary does not contain the detailed study information needed to fully answer all aspects of the request. The document is primarily a clearance letter from the FDA, confirming substantial equivalence to a predicate device, rather than a full study report.
Here's an analysis of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
This information is not provided in the given document. The FDA clearance letter typically summarizes the finding of substantial equivalence but does not detail the specific performance metrics or acceptance criteria used by the manufacturer in their submission.
2. Sample size used for the test set and the data provenance:
This information is not provided in the given document. The document is a regulatory clearance letter, not a clinical study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given document.
4. Adjudication method for the test set:
This information is not provided in the given document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
This information is not provided in the given document. This type of study is more common for diagnostic imaging devices, whereas this device is a blood pressure monitor.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described is a "Full Automatic (NIBP) Blood Pressure Monitor," which by its nature operates standalone to measure blood pressure. The "algorithm" here refers to the internal processing of the oscillometric method to derive blood pressure and heart rate. However, the document does not provide details of a specific standalone study or its performance metrics.
7. The type of ground truth used:
Given the device measures blood pressure, the ground truth would typically be reference blood pressure measurements obtained from a validated method (e.g., auscultatory method with a mercury sphygmomanometer) as per established standards for blood pressure device validation (e.g., ANSI/AAMI/ISO 81060-2). However, the document does not explicitly state the type of ground truth used in the manufacturer's testing.
8. The sample size for the training set:
This information is not provided in the given document. As the device likely uses an established oscillometric algorithm, there might not be a "training set" in the machine learning sense for its core function, but rather a validation against a reference standard. If machine learning were involved, the document does not elaborate.
9. How the ground truth for the training set was established:
This information is not provided in the given document.
In summary, the provided document is an FDA clearance letter for a blood pressure monitor. It confirms that the device was deemed "substantially equivalent" to predicate devices, meaning it has similar indications for use and safety/effectiveness profiles. However, it does not include the detailed technical or clinical study data (such as acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics) that would have been part of the manufacturer's 510(k) submission.
§ 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).