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TraceIT™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. TracelT hydrogel is intended to mark tissue for at least 3 months after injection.

TracelT Tissue Marker is a sterile, single use, polymerized polyethylene glycol (PEG) hydrogel that is delivered to mark a surgical location via a needle or cannula. The hydrogel material is visible under MRI, CT, and ultrasound for up to three months after the injection: The material hydrolyzes and is cleared from the body approximately six (6) months after injection.

The provided text is a 510(k) summary for the TraceIT™ Tissue Marker and supporting FDA correspondence. This documentation pertains to a medical device's regulatory clearance based on substantial equivalence to predicate devices, rather than a study demonstrating performance against specific acceptance criteria for an AI/ML diagnostic or prognostic device.

Therefore, the input does not contain the information requested to answer the questions about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details for an AI/ML device.

The document focuses on:

• Device Description: A sterile, single-use, polymerized polyethylene glycol (PEG) hydrogel delivered via needle or cannula to radiographically mark soft tissue.
• Indication for Use: To radiographically mark soft tissue during a surgical procedure or for future surgical procedures. Intended to mark tissue for at least 3 months after injection.
• Visibility: Visible under MRI, CT, and ultrasound for up to three months.
• Predicate Devices: BiomarC Tissue Marker (K001807) and Coaptite Tissue Marker (K012955).
• Performance Data: States "In vitro and in vivo preclinical tests were performed to verify and validate the safety and effectiveness of TraceIT Tissue Marker and assure substantial equivalence to the predicate devices." However, no specific performance metrics or acceptance criteria are detailed.
• Basis for Substantial Equivalence: Based on similar intended use, principle of operation, and technological characteristics to predicate devices.

Conclusion: The provided text does not include the detailed information required for the requested table and study breakdown concerning acceptance criteria and performance data for an AI/ML enabled device. This document is a regulatory submission demonstrating substantial equivalence, not a performance study of a diagnostic AI algorithm.

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