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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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The Mixed Media Markers (MMM) are intended to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The MMM can be visualized using medical imaging devices; the MMM provides a reference from which the treatment can be guided. MMM's not intended for use with ultrasonography.

These implanted markers are 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 be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.

The markers are fabricated of biocompatible materials. Specifically, gold (99.99%), medical grade titanium or PEEK Optima (polymer) with a medical grade stainless steel core.

They are available in varying lengths and have a diameter of 1.0 MM (+/- 0.2 MM)

They are intended for single use and are permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.

This document is a 510(k) summary for the Mixed Media Marker (MMM) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as one might find for a novel device. Therefore, much of the requested information regarding a formal study with acceptance criteria is not present in this document.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

The document does not explicitly define quantitative acceptance criteria for image-based performance, nor does it present a tabular comparison of such criteria against measured performance. Instead, it relies on a qualitative statement of equivalence.

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

This information is not provided in the document. No details on the sample size of markers tested, the type of data (e.g., in vivo, ex vivo, phantom studies), or data provenance are mentioned.

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. No ground truth establishment process by experts is described.

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

This information is not provided in the document. No adjudication method is mentioned.

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

There is no MRMC study mentioned, nor is there any AI component to this device. This document describes an implanted physical marker, not an AI-driven medical device.

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

This information is not applicable. The device is a physical marker; there is no algorithm or software component described that would have a standalone performance.

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

This information is not provided in the document. The document mainly focuses on demonstrating substantial equivalence through material changes and qualitative statements about visibility. There's no mention of a formal "ground truth" used for performance evaluation beyond general imaging visibility.

8. The sample size for the training set

This information is not applicable/provided. This device is a physical implanted marker and does not involve a "training set" in the context of machine learning or algorithms.

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

This information is not applicable/provided for the same reasons as point 8.

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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 FlexiMarc 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 is available in varying lengths from 2 mm overall to 4 CM overall and ranges in diameter from 0.5 mm to 1.6 mm so that it can be identified in the varying medical imaging formats. FlexiMarc is delivered in sterile preexisting needles ranging from 20 GA to 16 GA.

FlexiMarc is intended for single use and is permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.

Here's a breakdown of the acceptance criteria and study information for the FlexiMarc device based on the provided text:

Important Note: The provided 510(k) summary primarily focuses on the substantial equivalence of the FlexiMarc to a predicate device based on technological characteristics and image visibility. It does not detail a formal clinical study with acceptance criteria for device performance as would be expected for a complex AI/software device. Instead, the "study" is a comparison validating visual equivalence in various imaging modalities.

1. Table of Acceptance Criteria and Reported Device Performance

• CT
• CBCT
• MR
• kV x-ray
• MV x-ray | Visible in all modalities:
• CT: Visible
• CBCT: Visible
• MR: Visible
• kV x-ray: Visible
• MV x-ray: Visible (larger diameter markers required for both devices) |
  | Flexibility: Reduce potential for migration and provide a unique shape. | Fabricated to be flexible, which "serves to reduce the potential for migration of the marker" and "provides a unique shape form which the treatment area can be identified." |
  | Deployment method: Equivalent to predicate device. | "Both markers systems are deployed in the same fashion making this portion actually equivalent in its entirety." |
  | Material: Biocompatible. | Fabricated of all biocompatible pure gold. |
  | Availability (lengths/diameters): Varying sizes for different imaging and use cases. | Available in varying lengths (2 mm to 4 CM) and diameters (0.5 mm to 1.6 mm). |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the traditional sense. The "clinical performance comparison (image based)" describes testing both the FlexiMarc and the predicate device across various imaging modalities.
• Data Provenance: Not specified. It appears to be an internal comparison or bench testing rather than using patient data from a specific country or setting.
• Retrospective/Prospective: Not specified, but given the nature of the comparison, it likely involves imaging of the markers themselves rather than a clinical study on patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of a 510(k) for a physical marker, the "ground truth" for visibility would likely be established through objective observation by qualified personnel, possibly engineers or imaging specialists, rather than clinical experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The comparison focuses on the technological characteristics and imaging visibility of the device itself, not on human reader performance with or without AI assistance. This is a physical medical device, not an AI/software device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical implanted marker, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" primarily involved objective observation of marker visibility across different medical imaging modalities (CT, CBCT, MR, kV x-ray, MV x-ray) for both the FlexiMarc and the predicate device. It also included verification of physical characteristics like flexibility and material composition.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device. There is no concept of a "training set" as would apply to a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (See #8 above).

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