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The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

The Soma Access Systems ExactTrack™ I Procedure Kit consists of five disposable, sterile components: (1) needle/hub/magnet and needle protective sheath assembly, (2) cable sleeve, (3) elastic bands, (4) top shield assembly, and (5) bottom shield assembly. The needle/hub/magnet assembly consists of the needle, hub, magnet, and needle protective sheath. The needle is 18 gauge stainless steel and accepts a standard guidewire; the hub is an industry standard configuration modified to retain the magnet which is detected by OEM equipment electromagnetic sensors; the needle sheath protects the needle/hub/magnet during packaging and transportation. The cable sleeve is attached at one end to the assembled top and bottom shield by an elastic band and extends over the ultrasound transducer cable to prevent the transducer cable from coming in direct contact with the sterile field. The top and bottom shields' configuration has been designed to snap together while fitting tightly over OEM transducers. The top and bottom shields utilize a needle guide and needle lock during ultrasound procedures.

The provided 510(k) summary for the Soma Access Systems ExactTrack™ I Procedure Kit does not contain the detailed information typically found in acceptance criteria and study reports for software-based devices, especially those involving AI or image analysis. This device is a procedure kit, which is a physical medical device, not a software or AI-driven diagnostic tool.

Therefore, the requested information (acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not applicable and not present in the provided document.

The "Performance data" section states:
"Bench testing was performed to support a determination of substantial equivalence and consisted of comparative, biocompatibility, sterilization, and design verification. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. A risk analysis for the proposed device was performed, and testing was conducted to validate the systems overall operations."

This describes general engineering and safety testing for a hardware device, not the rigorous clinical or algorithmic performance evaluation typically associated with acceptance criteria for software or AI medical devices. It focuses on physical properties, safety, and functionality rather than diagnostic accuracy or clinical effectiveness metrics.

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