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The Visicoil MR Marker and the Pre-Loaded Visicoil MR Marker are indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Device Identification: the Visicoil MR is a helically wound coil of platinum wire. The product is available on a carrier for user-loaded implantation or pre-loaded in a needle.
Device Characteristics: The Visicoil MR is a linear fiducial marker. It is used for marking soft tissue for future therapeutic procedures.
Environment for Use: The Visicoil MR and Pre-Loaded Visicoil MR may be implanted in a healthcare facility, free standing clinic or physician's office.
Description of Device: The Visicoil MR Marker and the Pre-loaded Visicoil MR Marker is a sterile device, in the form of a platinum coil. Visicoil MR comes on a delivery system, packaged in a Mylar/Tyvek pouch, sterilized by gamma sterilization. The Pre-Loaded Visicoil MR comes in a 18, 19, 20, 21, or 22g 304 stainless steel needle and stylet with a beeswax plug at the tip, packaged in a Mylar/Tyvek pouch sterilized by EO sterilization.
The coils ranges in length from 0.3cm to 2cm and have an outside diameter that ranges between 0.3mm and 1.0mm. Platinum has a dense mass which allows for imaging in all x-ray based imaging devices and other electro-magnetic properties help to enhance visibility within Magnetic Resonance Imaging (MRI).
The device is a passive device and is permanently implanted in the patient.

This document describes a 510(k) premarket notification for the Visicoil MR Marker. It demonstrates substantial equivalence to predicate devices, but it does not contain information about an AI-powered device or a study proving that an AI device meets acceptance criteria.

The document is for a physical medical device (a radiographically visible marker for soft tissue) and focuses on changes in material composition (from gold to platinum) and its visibility under MRI, as well as biocompatibility and functional testing of the physical marker.

Therefore, I cannot provide an answer based on the prompt's requirements for acceptance criteria, study details, sample sizes, expert involvement, or AI performance, as this information is not present in the provided text.

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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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