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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 Surefire Precision 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 Surefire Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or

The Surefire Precision Infusion System is a medical device and the provided text describes its 510(k) summary, focusing on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "device performance" are not presented in the context of a diagnostic AI algorithm with specific metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are the performance specifications and the "device performance" refers to the results of the verification and validation tests, which show the device meets these specifications and performs comparably to the predicate.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a medical device (intravascular catheter) and not an AI algorithm, the "acceptance criteria" refer to established performance specifications for device function, and "reported device performance" refers to the successful demonstration that the device met these specifications during testing. The document does not provide a quantitative table of specific numerical acceptance criteria and their corresponding results but rather states that the device "meets the same performance specifications and acceptance criteria as the predicate device" and that "performance is comparable to the predicate device."

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

• Test Set Description: The "test set" here refers to the samples used in the performance testing and animal study for the physical device, not a dataset for an AI model.
• Sample Size: The document does not specify the exact numerical sample sizes for each performance test (e.g., number of catheters tested for burst pressure). It only generically states that various tests were performed. For the animal study, the sample size (number of animals) is not disclosed.
• Data Provenance: The biocompatibility testing was conducted by NAMSA (Northwood, OH), indicating US-based data. The performance testing (bench testing) was likely conducted in-house or by a contracted lab. The animal study was also performed to assess comparative acute performance. The general provenance is therefore related to device manufacturing and testing processes, not patient data from a specific country or whether it was retrospective/prospective in the AI sense.

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

This question is not directly applicable in the context of this traditional medical device submission. Ground truth, in the sense of expert consensus on diagnostic imaging, is not relevant here. The "ground truth" for the device's performance is established by objective engineering and biological testing against predefined specifications and comparison to the predicate device's established performance.

However, for the animal study, it notes that the performance was "as defined by physicians in a simulated clinical environment." This implies that physicians (experts) observed and evaluated the device's performance in the animal model. The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI studies where disagreements among experts need to be resolved. This is not applicable to a traditional medical device's performance testing. Device performance is determined by objective measurements and observations against acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this question is not applicable as the Surefire Precision Infusion System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is defined by:

• Objective Performance Specifications: These are engineering standards and safety requirements that the device must meet (e.g., tensile strength, burst pressure, coating durability).
• Predicate Device Performance: The "ground truth" for comparative performance is the established safe and effective performance of the legally marketed predicate device. The new device must demonstrate comparable performance.
• Biocompatibility Standards: Compliance with ISO 10993 series standards establishes the biological "ground truth" for material safety.
• Physician Assessment (Animal Study): In the animal study, the "ground truth" for acceptability and comparability was a qualitative assessment by physicians based on "defined user needs" in a simulated clinical environment.

8. The Sample Size for the Training Set

This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training.

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

This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training or a training set.

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