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The Cianna Medical SGS Tissue Marker is intended to be placed percutaneously in the breast to temporarily (

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The provided document is a 510(k) summary letter from the FDA to Cianna Medical, Inc. for the SGS Tissue Marker and System. This document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.

Specifically, the document:

• Confirms substantial equivalence to a predicate device.
• Lists the indications for use of the device (to temporarily mark a lumpectomy site in the breast and for non-imaging detection of the marker).
• States regulatory information such as the regulation number, class, and product code.
• Provides contact information for FDA divisions.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Information about standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this information, one would typically need to refer to the full 510(k) submission document, which often contains detailed technical and clinical study reports. The FDA 510(k) summary (which this document effectively is) summarizes the key findings but generally omits detailed study methodology and raw data.

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