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K Number
K982481
Device Name
A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR
Manufacturer
A & D ENGINEERING, INC.
Date Cleared
1998-09-25

(71 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The UA-767PC is designed to be used by end users who are eighteen (18) years and older at home and doctoring office to montor their blood pressure (systolic and diastolic and pulse rate. At the end of each measurement, the results will be stored in the UA-767PC memory. UA-767PC through its communication port can also transfer the measurements stored in nemory to other electronic devices, such as a PC, a modem, or a printer. The end user should not have common arthythmias, such as atrial or ventricular the measurement It is not designed for sul the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

Device Description

UA-767PC Digital Blood Pressure Monitor

AI/ML Overview

The provided text is a 510(k) clearance letter for the A&D Medical UA-767PC Digital Blood Pressure Monitor. It does not contain information regarding detailed acceptance criteria, the specific study design, or performance metrics beyond a statement of substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
  6. Whether a standalone performance study was done.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

The document's primary purpose is to confirm the device's clearance based on substantial equivalence, and it outlines the intended use and general regulatory requirements. It does not delve into the specifics of the clinical or performance studies conducted to demonstrate that equivalence.

§ 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).