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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 Renegade Fiber Braided Microcatheter is intended for general intravascular use, including neuro, peripheral, and coronary vasculature. The catheter can be coaxially tracked over a steerable quidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.

The device is a 3.0F/2.5F, single lumen catheter constructed with progressively softer shaft characteristics from its proximal to its distal ends. The device is tracked coaxially over a selectively placed guide wire. To facilitate catheter introduction, the device incorporates a hydrophilic coating applied to the outer sufface of the shaft. Once the subselective region has been accessed, the lumen of the catheter can be used for infusion of diagnostic agents, such as contrast medium, and therapeutic materials. The device is available in useable lengths of 130 cm and 150 cm and in distal segment lengths of 10cm, 20cm, and 30cm.

The provided document is a 510(k) summary for a medical device (intravascular infusion catheter) submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies that establish specific acceptance criteria and prove performance against those criteria in the way a modern clinical trial or AI/ML study would.

Therefore, the specific information requested in your prompt regarding acceptance criteria, study design for proving performance, and details related to AI/ML device testing (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in this document.

Historically, 510(k) submissions, especially from 1997, relied heavily on comparing device characteristics (materials, dimensions, mechanical properties, biocompatibility) and intended use to existing, legally marketed predicate devices. The "study" in this context refers to the comparison to predicate devices and bench/animal testing to show that any differences do not adversely affect safety and effectiveness.

Here's an attempt to answer based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific tensile strength, burst pressure, or flow rate thresholds that would confirm it "meets" a standard). Instead, the acceptance criteria are implicitly that the device is "substantially equivalent" to the predicate devices and that any dimensional/material differences "do not adversely affect safety and effectiveness."
• Reported Device Performance: The document states that "mechanical, biocompatibility and animal testing demonstrated that these differences [between the proposed device and predicate] do not adversely affect safety and effectiveness." However, it does not provide specific performance values (e.g., actual tensile strength measurements, flow rates, or animal study outcomes) to put into a table.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified. The document mentions "mechanical, biocompatibility and animal testing," but doesn't detail the number of units tested, animals used, or the origin of any data (e.g., country).
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This concept is not applicable to this type of device submission. There is no "ground truth" established by experts in the context of an AI/ML device for this intravascular catheter. Testing would have involved engineering assessments and biological responses.

4. Adjudication method for the test set

• Not applicable. There's no mention of a process requiring expert adjudication for assessing the performance of this type of catheter.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• Not applicable. MRMC studies are specific to diagnostic devices (often imaging-based) involving multiple human readers interpreting cases, usually with and without AI assistance. This is an intravascular catheter.

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

• Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

• The "ground truth" (or basis for evaluation) for this device would be established by:
  • Predicate Device Performance: The accepted safety and effectiveness profile of the Evolution Microcatheter, Eddy Infusion, TurboTracker Infusion Catheter, and Venture II™ Intravascular Infusion catheters.
  • Biocompatibility Standards: Compliance with established biocompatibility testing standards to ensure the materials are safe for in-vivo contact.
  • Mechanical Performance Specifications: The device's mechanical properties (e.g., flexibility, pushability, trackability, burst pressure) meeting internal design specifications and being comparable to predicate devices in a way that doesn't raise new safety/effectiveness concerns.
  • Animal Study Endpoints: For animal testing, outcomes related to tissue reaction, thrombus formation, or successful navigation/infusion without adverse events.

8. The sample size for the training set

• Not applicable. There is no AI/ML component or "training set" in this context.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a conventionally regulated medical device from 1997. It demonstrates substantial equivalence primarily through comparison to predicate devices and confirmation that any differences do not negatively impact safety and effectiveness, based on "mechanical, biocompatibility and animal testing." It does not contain the specific details about acceptance criteria, study sizes, expert involvement, or AI/ML-specific testing methodologies that your prompt requests, as those concepts are either not relevant to this type of device or were not part of regulatory submissions in that era.

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