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The TriSalus TriGuide Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The TriSalus TriGuide is intended to be used in the peripheral vascular system.

The TriSalus TriGuideTM Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. Its principle of operation is therefore to provide a patent pathway for compatible accessories as described within its labeling.

TriSalus TriGuideTM Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The TriSalus TriGuide Catheter has a three-layer construction, consisting of a PTFE inner liner, stainless steel braid mid-layer, and an extruded Pebax polymer outer shaft jacket. The Pebax extruded polymer is filled with barium suffate (BaSO4) as a radiopacifier, to provide visibility of the TriSalus TriGuideTM Guiding Catheter under fluoroscopy.

The TriSalus TriGuideTM Guiding Catheter are 65 cm in length in three pre-shaped tip designs including Axis, Sim 1, and Cobra to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic vessel tracking.

The provided text is a 510(k) summary for the TriSalus TriGuide™ Guiding Catheter, which is a medical device and not an AI/ML-enabled device. Therefore, the information requested in the prompt, which is typically relevant to the performance and validation of AI/ML software as a medical device, is not applicable to this submission.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through comparisons of indications for use, design, dimensions, materials, packaging, labeling, sterilization, and mechanical performance via bench and animal testing. It does not involve any AI/ML components, and thus "acceptance criteria" in this context refers to engineering specifications and performance benchmarks for a physical device, not AI model metrics.

Therefore, I cannot provide the requested information about acceptance criteria for an AI model, sample sizes for test sets (in the context of AI validation), expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth for AI, or training set details. These concepts do not apply to the TriSalus TriGuide™ Guiding Catheter as described in this FDA submission.

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The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The TriSalus® TriNav® LV Infusion System is a 0.025" lumen microcatheter, a self-expanding tip at the distal end. The TriNav® LV serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires with outer diameter up to 0.018" (0.46 mm), guiding catheters with inner diameter at least 0.048" (1.22 mm), embolic hydrogel particles 500 um or less in size and glass microspheres 110 um or less in size. The TriNav® LV has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels 3.0 mm to 5.0 mm in diameter. An optional, commercially available hemostasis valve (HV) is included. There are two radiopaque markers located at the distal end of the TriNav® LV device to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The TriSalus® TriNav® LV Infusion System is provided sterile (EtO) for single patient use.

The TriSalus® TriNav® LV Infusion System is explicitly stated as not having undergone clinical testing to demonstrate substantial equivalence. Instead, the submission relies on animal and bench performance test data. Therefore, the request for details on acceptance criteria and study proving the device meets them in the context of human clinical performance cannot be fully answered from the provided text.

However, based on the provided text, we can describe the performance testing conducted and the general acceptance criteria used:

The document states that the TriSalus® TriNav® LV Infusion System meets the same performance specifications and acceptance criteria as the predicate device. This implies that the acceptance criteria are tied to demonstrating equivalence or non-inferiority to the predicate device across various performance aspects.

Here's an attempt to extract relevant information based on the provided text, focusing on the type of studies conducted and what constitutes "performance" in this context for the device's clearance:

Device Performance Study (Bench and Animal Testing for Substantial Equivalence)

The performance of the TriSalus® TriNav® LV Infusion System was demonstrated through a series of bench testing and an animal study to show substantial equivalence to a predicate device (Surefire Spark Infusion System (rebranded as TriNav) K180677).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "meets the same performance specifications" and "acceptable/comparable" to the predicate device.
Since this document is a 510(k) summary, specific numerical acceptance thresholds and detailed performance results are not typically disclosed. However, the categories of performance evaluated are provided.

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

• Test Set (Bench Testing): Not specified.
• Test Set (Animal Study): Not specified. The text only states "An animal study was performed."
• Data Provenance: Not specified, but generally, bench testing would be conducted in a lab and animal studies in a vivarium. The studies are prospective in nature for device validation.

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

• Bench Testing: Not applicable in the context of human expert ground truth.
• Animal Study: The study assessed performance "as defined by physicians in a simulated clinical environment." The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

• Not specified. This is less relevant for bench and animal studies compared to human reader studies.

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

• No, an MRMC study was NOT done. The document explicitly states: "No clinical testing was required to demonstrate the substantial equivalence of the subject device to its predicates. Therefore, no pre-market clinical testing was performed nor is any included within this 510(k) submission."

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

• Not applicable as this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications, material standards, and comparisons against predicate device performance data (presumably internal data or published specifications for the predicate).
• Animal Study: Direct observation by "physicians" in a "simulated clinical environment" and relevant biological/physiological measurements. The "ground truth" for success was defined by "defined user needs" and "comparability to the predicate device."

8. The Sample Size for the Training Set

• Not applicable as this is a physical medical device, not a machine learning model.

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

• Not applicable.

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The TriSalus Infusion System is intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The TriSalus Infusion System is a 0.021" lumen coaxial microcatheter with the Expandable Tip at the distal end. The TriSalus Infusion System serves as the conduit for physician-specified agents. The device has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The Expandable Tip and distal section (100 cm) of the microcatheter are hydrophilically coated. The soft, pliable, Expandable Tip is sized for use in vessels of 2 mm to 6 mm. There are four radiopaque markers located at the distal end of the TriSalus Infusion System to aid in positioning of Expandable Tip. The Expandable Tip can be expanded or collapsed up to 5 times for repositioning during an interventional procedure by moving the thumb-slide back and forth. When expanded, the Expandable Tip is designed to improve infusion efficiency of diagnostic and therapeutic agents. A commercially-available pressure transducer may be attached to the sideport luer connector if pressure measurement during infusion is desired. The system is provided sterile (EO) and for single patient use.

The provided text describes the TriSalus Infusion System and its substantial equivalence to a predicate device, focusing on its design, intended use, and performance testing. However, it does not contain the detailed information necessary to complete a comprehensive table of acceptance criteria and reported device performance for an AI/ML device, nor does it detail a study proving such criteria for AI.

This document is an FDA 510(k) clearance summary for a medical device (a microcatheter), not an AI/ML software. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set sample size, how ground truth was established for training) are not applicable to the information provided.

I can, however, extract related information from the document that might be relevant if this were about a traditional medical device test.

Based on the provided document, here is an analysis of the available information regarding acceptance criteria and performance, as much as it can be applied to a non-AI medical device.

1. Table of acceptance criteria and the reported device performance:

The document summarizes performance testing but does not provide specific quantitative acceptance criteria or detailed numerical performance results in a table format. It generally states that the device "meets its specified performance requirements" and "performed comparably to the predicate device."

Here's an attempt to structure a table based on the types of tests mentioned, but without specific numerical criteria or results:

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

• Sample Size for Test Set: Not specified in the document for any of the bench tests. For the animal study, the sample size is also not specified, only that "An animal study was performed."
• Data Provenance: Not specified.

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 question is more applicable to AI/ML studies where human expert consensus often defines ground truth. For this medical device, performance requirements are likely based on engineering specifications and direct physical measurements.
• The animal study mentions "defined by physicians in a simulated clinical environment," implying expert input, but details on the number or qualifications of these physicians are not provided.

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

• Not applicable/Not specified for this type of medical device testing. Adjudication methods are typically used in clinical trials or AI/ML ground truth establishment.

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:

• No. This is an MRMC study for AI/ML. The document describes testing for a physical medical device (catheter), not an AI.

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

• Not applicable. This document is not about an algorithm or AI.

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

• Since this is a physical device, "ground truth" would be defined by engineering specifications, physical measurements (e.g., burst pressure limits), and observed functional performance during bench and animal testing. For the animal study, performance was assessed against "defined user needs" as determined by physicians, which could be considered a form of expert-informed functional assessment.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML product, so there is no "training set."

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

• Not applicable. No training set exists for this device.

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