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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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The Surefire Spark 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 Spark Infusion System is a 0.021" lumen microcatheter with a seff-expanding tip at the distal end. The Surefire Spark 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 500um or less in size and glass microspheres 110um or less in size. The Surefire Spark 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 of 1.5-3.5mm.

There are two radiopaque markers located at the distal end of the Surefire Spark 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 Surefire Spark Infusion System is provided sterile (EtO) for single patient use.

The Surefire Infusion Systems will be available in the following sizes:

Inner Diameter: 0.021 inch, Length: 120 cm, Tip / Vessel Size: 1.5 - 3.5 mm
Inner Diameter: 0.021 inch, Length: 150 cm, Tip / Vessel Size: 1.5 - 3.5 mm

The Surefire Spark Infusion System is a medical device and the provided text describes its 510(k) premarket notification to the FDA. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical study with quantifiable acceptance criteria for diagnostic performance metrics like sensitivity or specificity.

Therefore, many of the requested categories for a study proving device acceptance (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device and regulatory submission as described in the provided text. The device is an intravascular catheter designed for delivering agents, not for diagnosis or image interpretation.

Instead, the acceptance criteria and performance evaluation for this device revolve around engineering and physical performance tests, and a comparative animal study against a predicate device.

Here's the information that can be extracted and inferred from the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Surefire Spark Infusion System are implicitly defined by meeting the same performance specifications as its predicate device and demonstrating comparable performance in various physical and functional tests. The study demonstrates that the device met these criteria.

• Visual and Dimensional (Implicitly met comparable dimensions)
• Tensile (Pull) Strengths
• Kink Radius
• Torque Resistance
• Burst Pressure
• Coating Frictional Force
• Base Catheter Insertion/Retraction Force
• Corrosion Resistance
• Hub Solvent Compatibility
• Coating Durability and Uniformity
• Particulates
• Pouch Integrity
• Pouch Seal Strength
  Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
  | Functional Compatibility | The Surefire Spark Infusion System met the same performance specifications for:
• Diagnostic Agent Compatibility
• Embolic Agent Compatibility
• Hub Aspiration
• Antegrade Flow
• Infusion Efficiency
  Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
  | Biocompatibility | No direct new biocompatibility testing was performed on the subject device. Testing was leveraged from previously cleared predicate devices (Surefire High Flow Microcatheter K121677, Surefire Guiding Catheter K162359, and Surefire Precision Infusion System K171355), implying that the materials are deemed biocompatible based on prior assessments. |
  | Thrombogenicity | Testing for thrombogenicity was performed on the Surefire Spark Infusion System Catheter as a part of an Animal Study. (Specific results are not detailed, but the overall conclusion of the animal study indicates acceptability). |
  | Sterilization Residuals | EtO Residuals testing was leveraged from previous testing of the predicate device. |
  | Acute Performance (Animal Study) | "An animal study was performed to assess the comparative acute performance of the Surefire Spark Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The Surefire Spark Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device." |

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for each bench test. For the animal study, the sample size is not specified beyond "An animal study was performed."
   • Data Provenance: The bench tests and animal study were performed by the manufacturer to support the 510(k) submission. No country of origin is specified for the data, but the manufacturer is based in Westminster, CO, USA. The study would be considered prospective for the purpose of demonstrating equivalence for this specific device.

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

   • Bench Tests: Not applicable in the sense of expert review for ground truth on performance specifications. These are objective engineering measurements against defined criteria.
   • Animal Study: The acute performance was "defined by physicians in a simulated clinical environment." The number and qualifications of these "physicians" are not specified. Their role was to assess performance, not establish ground truth in a diagnostic sense.

3. Adjudication method for the test set:

   • Not applicable as the tests involve objective measurements (bench tests) or physician assessment (animal study) rather than diagnostic interpretation requiring adjudication.

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:

   • No MRMC study was done. This device is an intravascular catheter for substance delivery, not an AI-powered diagnostic tool, so such a study is not relevant to its regulatory approval in this context.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • For the bench tests, the "ground truth" is defined by established engineering and material performance specifications which the device must meet or perform comparably to the predicate.
   • For the animal study, the "ground truth" for acute performance was based on "user needs" defined by physicians in a simulated clinical environment and comparison to the predicate device's performance.

7. The sample size for the training set:

   • Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

   • Not applicable as there is no training set mentioned or implied.

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

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

The Surefire 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 Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.

The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.

The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

This document describes the Surefire Guiding Catheter, a medical device, and its acceptance criteria as demonstrated through various studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests performed to demonstrate the safety and effectiveness of the Surefire Guiding Catheter and its equivalence to a predicate device. The acceptance criteria are implicitly met by the successful completion of these tests and the determination of substantial equivalence.

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