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The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

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I am sorry, but the provided text does not contain the detailed information needed to fill out the table and answer all the questions about the acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device (Barco Mammo Tomosynthesis, MDMG-5221), which confirms that the device is substantially equivalent to a legally marketed predicate device.

While it mentions the device's indications for use (displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners, and specifically designed for breast tomosynthesis applications), it does not include:

• A table of acceptance criteria and reported device performance.
• Details about the study design, sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test or training sets.
• Information on MRMC studies, standalone performance, or the type of ground truth used.

This type of information is typically found in the 510(k) summary or the full submission, which is not provided in the given text.

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