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

The Cianna Medical Tissue Marker and Delivery System is comprised of an implantable marker and a delivery system. The marker is comprised of a series of 1 mm diameter titanium "beads" which are constrained onto a heat shaped nitinol wire. The marker is preloaded within the lumen of the delivery system. Once percutaneously deployed from the delivery system, the marker maintains a coiled shape (approximately 4.5mm diameter by 5mm length) in the tissue. The marker is echogenic under Ultrasound, radiopaque under radiograph imaging.. The Cianna Medical Tissue Marker and Delivery System is provided sterile, and is for single use only.

The provided text describes the Cianna Medical Tissue Marker and Delivery System and its 510(k) submission (K120804). However, it does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic performance or clinical effectiveness.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device's technological characteristics, intended use, and principle of operation to predicate devices (K102506, K111692, K090501).
• Non-Clinical Performance Data: This section details various biocompatibility and material safety tests performed on the device components (e.g., cytotoxicity, sensitization, systemic toxicity, pyrogenicity, mutagenicity, implantation). These are common tests for implantable medical devices to ensure safety and material compatibility.
• Clinical Data: Explicitly states, "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."

Therefore, based on the provided text, I cannot provide the requested information about acceptance criteria for diagnostic performance or a study demonstrating the device meets such criteria because:

1. No acceptance criteria for diagnostic performance are listed. The "acceptance criteria" discussed are implicitly related to the "Pass" or "Fail" results of the non-clinical (biocompatibility) tests.
2. No study demonstrating the device meets diagnostic performance criteria is described. The document states that no clinical data was used for substantial equivalence.

If you are looking for information regarding the diagnostic performance of a device (e.g., sensitivity, specificity, AUC), that kind of data is not present in this 510(k) summary. This document primarily demonstrates the safety and material compatibility of the tissue marker and its substantial equivalence to existing markers based on design and intended use, not its diagnostic accuracy in identifying or characterizing a medical condition.

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