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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 Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Here's an analysis of the provided text regarding the Renegade™ Fiber Braided Microcatheter, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) summary and FDA clearance letter. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than performing de novo studies to establish new acceptance criteria and prove performance against those criteria in the same way a PMA (Pre-Market Approval) would. Therefore, much of the requested information (like specific performance acceptance criteria, detailed study designs, and ground truth establishment) is typically not found in this type of document because the focus is on comparison, not novel claims.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantifiable acceptance criteria and their corresponding reported device performance values are not explicitly stated in a numerical or metric-based format. The submission focuses on demonstrating substantial equivalence.

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

• Sample Size for Test Set: Not specified in the provided document. The 510(k) summary indicates that the device was "tested and compared to the predicate device," but details about the size of the test set for this comparison are not included.
• Data Provenance: Not specified. Typically, such testing would be in-house or contracted by the manufacturer, but the geographical origin or whether it was retrospective/prospective is not mentioned.

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

• Number of Experts & Qualifications: Not applicable/not provided. For a 510(k) submission focused on substantial equivalence, the "ground truth" is typically the performance of the legally marketed predicate device, and the comparison involves engineering testing or bench testing, not expert-based clinical performance data requiring ground truth establishment in the traditional sense (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not provided. As the tests are primarily engineering or bench tests for substantial equivalence, clinical adjudication methods are not relevant.

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

• MRMC Study: No. The provided text does not describe an MRMC comparative effectiveness study. The submission is for a medical device (microcatheter), not AI software, and the clearance pathway is 510(k), which focuses on substantial equivalence rather than comparative clinical efficacy studies.

• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI device.

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

• Standalone Performance Study: Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the purpose of a 510(k) submission for a physical device, the "ground truth" is largely derived from the established safety and effectiveness profile of the predicate device. The tests conducted are designed to show that the new device performs comparably to that predicate in relevant engineering and biocompatibility parameters.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is a physical medical device submission, there is no "training set" in the context of machine learning or AI.

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

• Ground Truth for Training Set: Not applicable, as there is no training set mentioned in the context of this device.

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The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.

The major components of the Vaxcel™ Dialysis Catheter are the dual lumen catheter, hub, injection cap, introducer sheath/dilator and metal tunneler with protective sheath.

This a Vaxcel™ Dialysis Catheter, which is a Class III medical device. There is no information in the provided text to calculate the performance of the device or the acceptance criteria. The document is simply a 510(k) summary and the FDA's clearance letter, stating that the device is substantially equivalent to a predicate device.

Here's why the requested information cannot be extracted:

• No Acceptance Criteria or Performance Data: The provided text does not include any acceptance criteria, performance metrics, or study results for the Vaxcel™ Dialysis Catheter itself. The "Summary of Substantial Equivalence" section only states: "The Vaxcel Dialysis catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This is a high-level statement and does not detail the specific tests, their results, or the acceptance thresholds.
• Focus on Substantial Equivalence, Not Performance Study: The entire submission and the FDA's response revolve around the concept of "Substantial Equivalence" to a legally marketed predicate device (also named Vaxcel™ Dialysis Catheter) under 510(k) regulations. This means the manufacturer argued the new device is as safe and effective as the existing one, not necessarily that it met specific, newly defined performance criteria in a clinical study.
• No Clinical Study Details: There is no mention of a human clinical study, an AI component, or any details about sample sizes, expert involvement, ground truth, or adjudication methods for either a test or training set.
• Not an AI/Diagnostic Device: The Vaxcel™ Dialysis Catheter is a physical medical device (a catheter) for hemodialysis and apheresis, not a diagnostic algorithm or an AI-powered system that requires performance metrics like sensitivity, specificity, or reader studies.

Therefore, since the device is a physical catheter and the submission focuses on substantial equivalence rather than a detailed performance study against specific criteria, none of the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth type, or training set details) can be provided from the given document.

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The Hemashield Gold ™ Woven Double Velour Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

The Branch Graft Configurations is different from the rest of the Hemashield Gold Woven Double Velour Vascular Graft product line only in the 1-4 branch configuration in which the grafts are sewn. The modified vascular grafts have the following similarities to those which previously received 510(k) concurrence: Identical indications for use, Identical labeling, Identical manufacturing processes, Identical operating principle, Incorporate identical materials, Have the identical shelf-life (5 years), Are packaged and sterilized using identical packaging materials and processes.

The provided submission for the Hemashield Gold Woven Double Velour Branch Graft is a Special 510(k) for a device modification, focusing on the branch configuration. The document explicitly states that there is "no change to these tests or to their acceptance criteria for the Branch Graft line extension" and that "all testing was done with standard test methods for these parameters". This indicates that the device's performance for these criteria was demonstrated to meet existing standards, rather than new studies being conducted specifically for this modification.

Due to the nature of this submission being a device modification to an already approved device and the stated lack of change in acceptance criteria for the branch graft line extension, detailed new studies with specific sample sizes, ground truth establishment, or multi-reader multi-case analyses are not part of this document. The performance is assumed to be in compliance with the established methods for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

10.0 mm sizes; nominal diameter ± 1.0 mm | Met |
| Visual Inspection - Sewing | No sewing defects | Met (Implied by "Pass" for related categories) |
| Air Permeability | $\le$ 24.5 - 43.5 l/m (depending upon size) | Met |
| Pyrogenicity: Rabbit Pyrogen | Pass | Pass |
| Acute Systemic Toxicity: Acute Systemic Injection | Pass | Pass |
| Irritation: Acute Intracutaneous Reactivity | Pass | Pass |
| Hemocompatibility: Hemolysis | Pass | Pass |
| Cytotoxicity: ISO L929 MEM Elution | Pass | Pass |
| Mutagenicity: Ames Test (Saline extract) | Pass | Pass |
| Subchronic toxicity: 14 day IV injection in rats | Pass | Pass |
| Implantation: ISO Muscle Implantation with histopathology (2 week) | Pass | Pass |
| Implantation: ISO Muscle Implantation with histopathology (12 week) | Pass | Pass |
| Physiochemical | Pass | Pass |
| Shelf Life Testing | Meets Product Specification after aging | Met Product Specification after aging (Implied by "Pass") |

Information Not Applicable to this Submission:

The following information is not provided in the original text as the submission is for a device modification where existing acceptance criteria and methods were used, rather than a new de novo study with specific performance endpoints outlined in these categories. The emphasis is on substantial equivalence to the predicate device, confirming that the modified device continues to meet the established performance and safety characteristics of the existing product line.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   • Not specified. The document indicates that "All testing was done with standard test methods for these parameters" and that "There is no change to these tests or to their acceptance criteria for the Branch Graft line extension." This suggests that the established test methods for the predicate device were applied, without specifying new sample sizes or data provenance for this specific modification.
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)
   • Not applicable. This is a medical device for vascular repair, not an image analysis or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Not applicable. This is a medical device for vascular repair.
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 a medical device for vascular repair, not an AI or diagnostic device involving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not applicable. This is a medical device for vascular repair, not an AI or diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   • For the physical and biological tests, "ground truth" is established by the specified acceptance criteria for each test (e.g., specific dimensions, permeability rates, "Pass" for biocompatibility).
8. The sample size for the training set
   • Not applicable. This is a medical device for vascular repair, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
   • Not applicable. This is a medical device for vascular repair.

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The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.

The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.

The provided document is a 510(k) summary for a medical device (Imager II Angiographic Catheter) seeking substantial equivalence to a predicate device. It primarily discusses regulatory compliance and biocompatibility. It does not present a study proving the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would.

Instead, the document states that the device has been tested and compared to a predicate device, and all data gathered demonstrate substantial equivalence. The "acceptance criteria" here are geared towards regulatory approval rather than clinical performance metrics.

Therefore, many of the requested details about statistical studies, sample sizes, ground truth establishment, and expert involvement are not available in this type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any specific performance or equivalence testing. The 510(k) process relies on demonstrating equivalence through various engineering, performance, and biocompatibility tests, not typically a large-scale clinical "test set" as understood in AI/ML studies.
• Data Provenance: Not specified. Testing would have been conducted by the manufacturer, Boston Scientific/Medi-Tech, likely under controlled laboratory conditions, possibly involving internal tests and external contract labs for biocompatibility.

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

• Not applicable in the context of this 510(k) submission. The ground truth for biocompatibility is established by ISO 10993 standards and testing protocols. For substantial equivalence, it's a comparison to the known performance and characteristics of the predicate device. There is no mention of human expert-labeled "ground truth" data sets.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a formal adjudication process for interpreting test results in the way one would for clinical image reviews.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document describes a 510(k) submission for an angiographic catheter, which is a physical medical device. MRMC studies are typically performed for diagnostic imaging devices or AI-powered algorithms to assess human reader performance with and without assistance. This device does not fall into that category.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: Established by international standards (ISO 10993) and the results of specific biological evaluations (e.g., cytotoxicity, sensitization, irritation tests).
• For Substantial Equivalence: Comparison to the known specifications, materials, and intended use of the legally marketed predicate device (NightHawk Angiographic Catheter).

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this type of device and regulatory submission. This is not an AI/ML device.

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

• Not applicable. As above, there is no AI/ML training set. Any internal developmental testing or engineering validation would have relied on established engineering principles, material science, and test methods.

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