Search Results

Ask a specific question about this device

The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 229 mm -330 mm (approx.: 9 ~ 13 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

AViTA BPM6x Series Arm Type Blood Pressure Monitor

The provided text is a 510(k) summary from the FDA for the AViTA BPM6x Series Arm Type Blood Pressure Monitor. It outlines the device's indications for use and states that it has been found substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed acceptance criteria and study information requested.

The document is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This sort of data is typically found in a clinical study report, which is not included.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging devices.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This is also more relevant for AI-driven diagnostic devices.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned. This would be relevant for machine learning-based algorithms, which is not explicitly stated to be part of this blood pressure monitor.
• How the ground truth for the training set was established: Not mentioned.

What the document does indicate about the device:

• Device Name: AViTA BPM6x Series Arm Type Blood Pressure Monitor
• Intended Use: Measures systolic and diastolic blood pressure and pulse rate of an adult individual using a non-invasive oscillometric technique with an inflatable arm cuff.
• Cuff Circumference: Limited to 229 mm - 330 mm (approx. 9-13 inches).
• Intended Environment: Home use.
• Additional Feature: Detects irregular heartbeats during measurement and displays a symbol along with readings.
• Regulatory Classification: Class II (two) medical device.
• Product Code: DXN (Noninvasive blood pressure measurement system).
• Approval Type: 510(k) premarket notification (meaning it was found substantially equivalent to a predicate device).

To obtain the detailed acceptance criteria and study data, one would typically need access to the full 510(k) submission, which includes test reports and clinical data. This public summary only confirms the FDA's decision based on that submission.

Ask a specific question about this device