Search Results

To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

Rossmax Automatic Wristwatch Blood Pressure Monitor, model V46

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a blood pressure monitor. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or validation protocol.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices..." This indicates that the device's approval is based on substantial equivalence to existing devices, not on a new, independently presented and detailed clinical study report within this document.

What can be extracted from the text related to this request:

• Device Name: Rossmax Automax WristWatch Blood Pressure Monitor, model V46
• Intended Use: To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method.
• Limitations: Limited to patients over 18 years and wrist circumference between 5.3 to 7.7 inches.
• Regulatory Basis: Substantial equivalence to legally marketed predicate devices.

To answer your request comprehensively, one would need access to the actual 510(k) submission documentation, which would include the testing and comparison performed to demonstrate substantial equivalence to the predicate device, likely referencing a standard like ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type).

In summary, based only on the provided text, the answer is: the document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

Ask a specific question about this device