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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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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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The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.

The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. The major components of the Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula, flexible stiffening cannula and luer cap.

The provided text is a summary of a 510(k) premarket notification for the Flexima™ Biliary Catheter.

This document DOES NOT contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness study (MRMC or standalone AI performance).

The document focuses on demonstrating substantial equivalence to a predicate device. This typically involves performance testing to show the new device functions similarly to the existing device, but it doesn't usually include the kind of detailed clinical study information (like ground truth establishment, expert adjudication, or AI performance metrics) requested in your prompt, especially for a non-AI medical device like a biliary catheter.

Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.

Here's an explanation of why the requested information is absent based on the document:

• Type of Device: The Flexima Biliary Catheter is a physical medical device for drainage, not an AI or imaging-based diagnostic tool. The performance criteria for such devices typically revolve around mechanical properties, biocompatibility, and functional equivalence, rather than diagnostic accuracy metrics.
• Regulatory Pathway (510(k)): The 510(k) pathway, particularly a Special 510(k) in this case, primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves bench testing, limited animal studies, or comparison of design specifications, rather than large-scale human clinical trials or complex AI performance evaluations.
• Content of the Summary: The provided text is a "Summary of Safety and Effectiveness" which briefly outlines the device, its intended use, and states that "All data gathered demonstrate this device as substantially equivalent." It does not elaborate on the specific tests or their results.

To directly address your prompt points, given the provided text, I can only state that this information is not available:

1. A table of acceptance criteria and the reported device performance: Not provided. The document generally states "All data gathered demonstrate this device as substantially equivalent," but no specific performance criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not provided. The type of testing and sample sizes are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth in this context (for a physical catheter) would likely relate to objective measurements of device properties rather than expert consensus on diagnostic images.
4. Adjudication method: Not applicable/Not provided.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used: Not applicable/Not provided.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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The Flexima™ Nasobiliary Catheter is indicated for prolonged access to the biliary ductal system via the nose, including:

• Decompression of an obstructed bile duct in acute suppurative cholangitis.
• Temporary or short-term decompression of the common bile duct, similar to that which follows unsuccessful stone extraction after endoscopic sphincterotomy.
• Prevention of stone impaction after endoscopic sphincterotomy.
• Infusion of contrast medium for repeat cholangiography.
• Instillation of various therapeutic solutions, including antibiotics (for acute bacterial cholangitis) or saline (to flush sludge or small stones after endoscopic sphincterotomy).
• Preoperative biliary decompression to decrease jaundice (thereby decreasing perioperative complications) in patients undergoing elective biliary tract surgery.
• Temporary biliary decompression in patients who are septic or who have severe coagulopathy. Once infection has been controlled or coagulopathy corrected, sphincterotomy can be performed, and a large stent can be inserted for long-term therapy.
• Access for intraluminal irradiation therapy, using iridium.
• Aspiration of bile for chemical and bacteriologic studies (e.g., to identify causative agents in bacterial cholangitis or to determine the lithogenicity of bile in patients with cholestasis).
• Facilitating the healing process in traumatic or surgical biliary fistulae.

Not Found

The provided text describes a 510(k) premarket notification for the Flexima™ Nasobiliary Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new performance study to establish specific acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity for an AI algorithm).

The "Performance Characteristics" section explicitly states: "Laboratory testing regarding characteristics was performed on Flexima™ Nasobiliary Catheter to verify its safety and performance." and "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Flexima™ Nasobiliary Catheter with satisfactory results."

This indicates that the "acceptance criteria" and "device performance" relate to the physical and material characteristics of the catheter (e.g., integrity, flow rates, material safety, sterility) and not to a diagnostic accuracy or AI software performance as would be relevant to the questions posed.

Therefore, most of the requested information regarding sample size, data provenance, ground truth, expert opinions, MRMC studies, or standalone algorithm performance is not applicable to this submission, as it is a device (catheter) and not an AI/diagnostic software.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance for Flexima™ Nasobiliary Catheter

Additional Information Relevant to AI/Diagnostic Studies (Not Applicable to this Device)

1. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device (catheter), not a diagnostic algorithm that would use a test set of data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth was established for this device.
3. Adjudication method for the test set: Not applicable.
4. 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 is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device like this relates to its physical and material properties meeting specifications.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

Conclusion from document: The submission for the Flexima™ Nasobiliary Catheter primarily relies on demonstrating substantial equivalence to existing predicate devices and providing evidence of the device's safety (biocompatibility, sterility, pyrogenicity) and physical performance through laboratory testing. It does not involve diagnostic performance metrics or AI algorithm evaluation.

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