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In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarcs can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.

FlexiMarc is an implanted marker used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.

The FlexiMarc soft tissue marker is fabricated of all biocompatible pure gold. It will be available in varying lengths from 3 MM to 4 CM overall and will range in diameter from 0.35 MM to 1.6 MM. It will be available in single and multi-node formats. These are detailed in the table below. FlexiMarc is delivered in sterile preexisting needles ranging from 25 GA to 14 GA, solo in a sterile pouch, or in nonsterile bulk.

This submission for Cortex Manufacturing Inc.'s FlexiMarc (K142294) is a special 510(k) submission, indicating that the device has been modified to address a specific change from a previously cleared device. In this instance, the modification is solely to the diameter range of the implanted marker. As such, the submission primarily focuses on demonstrating that this single change does not impact the safety and effectiveness of the device compared to its predicate.

Here's an analysis of the provided text in the context of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" or a "reported device performance" table in the way one might expect for a comprehensive clinical study. Given that this is a 510(k) for a modification (a smaller diameter range), the primary acceptance criterion is demonstrating that the modified device is substantially equivalent to the predicate device and that the change does not introduce new safety or effectiveness concerns.

The core of the performance demonstration relates to marker visibility and migration, particularly for the smaller diameter.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to a "substantial body of published work" for the marker migration data, stating: "In these studies markers were placed in live participants in the torso region of the body specifically including the GI tract and pancreas. In these studies several markers in the 0.35 MM diameter range were implanted."

• Sample Size: The exact sample size for these "published studies" is not provided in this document. It only mentions "several markers in the 0.35 MM diameter range were implanted."
• Data Provenance: Not specified (e.g., country of origin).
• Retrospective or Prospective: Not explicitly stated, but the description "markers were placed in live participants" and "distances between the markers were compared overtime" suggests these were prospective clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The general reference to "published work" implies that experts in the field conducted and assessed these studies, but their specific number or qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a passive implanted marker, not an AI-assisted diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No, a standalone algorithm performance study was not done. This device is an implanted medical marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the marker migration assessment, the ground truth appears to be based on direct measurement of marker distances over time in live participants, presumably evaluated against a baseline measurement. This would be considered outcomes data (i.e., the physical outcome of marker position). For visibility, the ground truth would be the physical presence of the marker as confirmed by imaging modalities.

8. The sample size for the training set

This is not applicable as FlexiMarc is a physical implanted medical device, not an AI/ML algorithm that requires a training set. The "published work" referenced is for clinical validation of marker properties, not for training a model.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as #8.

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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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