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The LumiCoil Platinum Fiducial Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The LumiCoil Platinum Fiducial Marker is a helically wound coil made of a platinum alloy wire. The outer diameter of the coil is 0.46mm. The alloy wire is comprised of ~92% platinum and ~8% tungsten. The LumiCoil Marker is available in two shape configurations: straight and figure 8. The length of the fiducial markers when implanted is 5mm.

The LumiCoil Marker is recommended to be placed using the 22ga Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle.

The provided text describes a 510(k) premarket notification for the LumiCoil Platinum Fiducial Marker, seeking substantial equivalence to predicate devices. It focuses on the device description, indications for use, and technological characteristics, along with a high-level mention of performance data. However, the document does not contain the detailed information requested regarding specific acceptance criteria, study performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details or effect size.
6. Description of standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the following regarding performance:

• "Non-clinical performance bench testing and simulated use testing were completed to evaluate the design of the LumiCoil Marker for its indications for use."
• "Comparative testing was performed to demonstrate the visibility of the LumiCoil Marker and the predicate Visicoil Marker."

It does not provide the results of these tests, set specific acceptance criteria, or describe the methodology in a way that allows for answering your detailed questions. This is typical for a 510(k) summary, which provides an overview rather than the full study reports.

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