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Gold Anchor is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Gold Anchor Marker consists of a thin gold wire with cutouts delivered in a fine needle. The Gold Anchor Marker is available pre-loaded in two different sizes of fine needles: Gold Anchor 120 comes in a 0.53 mm x 120 mm (25 G x 4 3/4") fine needle with an attached injector, and Gold Anchor 200 comes in a 0.7mm x 203mm (22G x 8") fine needle. The Gold Anchor comes in blister single packs, sterilized, ready for use, in lengths of 1-5cm, clearly indicated on the package. They shall be implanted under guidance of ultrasound or CT or during manual palpation of the tumor. The Gold Anchor Marker can be inserted in the tissue in two ways, either through advancing the stylet or by withdrawing the needle. If the stylet is advanced rather than the needle withdrawn, the Gold Anchor Marker will collapse and fold into different shapes. By withdrawing the needle the Gold Anchor Marker will be deposited as a straight line in the needle track.

This 510(k) submission (K091645) from Naslund Medical AB for the "Gold Anchor" device does not contain a study section that describes acceptance criteria and proves the device meets them with performance data.

Instead, this submission is a Traditional 510(k) submission based on substantial equivalence to a predicate device.

Here's why the requested information cannot be found in the provided text:

• No Clinical Information: The document explicitly states: "Does the submission include clinical information? No". This indicates that no clinical studies were performed or submitted.
• Focus on Substantial Equivalence: The bulk of the information in sections 8.1-8.7 is dedicated to comparing the Gold Anchor to its predicate device (Preloaded RadioMed Soft Tissue Marker, K070305) to demonstrate substantial equivalence based on design, materials, intended use, and general performance characteristics, rather than presenting original performance data against specific acceptance criteria.
• "Performance: Same as predicate device": In section 8.5, under "Scientific technology - Preloaded RadioMed Soft Tissue Marker", it states "Performance: Same as predicate device". This further confirms that no new performance data is being presented, but rather the performance is assumed to be equivalent to the predicate.
• "No change in scientific technology": The comparative tables repeatedly assert "No Change in scientific technology" for various characteristics, implying that the device's fundamental function and resultant performance are not expected to differ significantly from the predicate.

Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication, MRMC, standalone studies, and training set details) is not available in this 510(k) submission.

The FDA's clearance letter (pages 5-7) confirms that the device was deemed substantially equivalent based on the provided information, which primarily focused on the comparison to the predicate device to establish safety and effectiveness.

To directly answer the prompt's requirements based on the provided text, I must state that the information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on establishing substantial equivalence to a predicate device, assuming similar performance.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data is presented.
4. Adjudication method for the test set: Not applicable, as no test set data is presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a passive marking device, not an AI-assisted diagnostic or therapeutic system. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance data based on ground truth is presented.
8. The sample size for the training set: Not applicable, as no training set for an algorithm is used.
9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is used.

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