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The Infusion Aspiration Catheter System consists of the Infusion Wireform Catheter, Aspiration Guide Catheter, and Retraction Aspirator Device. The Infusion Aspiration Catheter System is indicated for:
● The non-surgical removal of emboli and thrombi from blood vessels.
● Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Infusion Aspiration Catheter System is intended for use in the peripheral vasculature.

The Infusion Wireform Catheter consists of a single lumen Delivery Catheter containing a second internal catheter. The internal Wireform Catheter has a hollow flexible shaft with self-expanding wireform disks attached to its distal end. The wireform disks are available in 3 sizes for treatment of vessels with diameter of 6-10 mm, 11-14 mm, or 15-18 mm.
The Aspiration Guide Catheter is introduced over a previously placed 0.035" exchange length guidewire. A dilator compatible with the 0.035" guidewire is provided for the Guide Catheter to assist in its advancement.
The Dilator/Guide Catheter assembly is advanced in the patient's vasculature to a location proximal of the obstruction. The dilator is withdrawn and replaced with the Infusion Wireform Catheter which is advanced distal to the obstruction. The wireform disks are deployed by retracting Delivery Catheter.
By aspiration and withdrawal of the Infusion Wireform Catheter into the Guide Catheter, the obstructing material may be disrupted or removed.
The Retraction Aspirator Device is available to facilitate the simultaneous aspiration and withdrawal of the Infusion Wireform Catheter into the Guide Catheter. The hand-lever operated Retraction Aspirator Device is fitted with a vacuum syringe and collection container. Operating the Retraction Aspirator Device lever simultaneously retracts the Infusion Wireform Catheter into the Guide Catheter and aspirates fluids.

The provided document describes the Infusion Aspiration Catheter System and details the non-clinical testing performed to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria or quantitative performance measures for the device. Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed.

Based on the available information, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated in the document, this table cannot be fully completed with numerical values. The document generally states that "Test results demonstrated that all acceptance criteria were met, and, therefore, the device conforms to expected device performance and intended use."

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

The document does not explicitly state the sample sizes for each non-clinical test. It mentions:

• Accelerated aging studies: Conducted on "sterilized (ethylene oxide), accelerated-aged devices." The specific number of devices is not provided.
• Simulated Use Tracking: Refers to "consistent removal of simulated thrombus from the simulated vessels in testing." The number of simulated vessels or test iterations is not specified.
• Animal study: "Acute evaluation of the safety and performance of the Inari Infusion Wireform Catheter, Aspiration Guide Catheter, and the Retraction Aspirator Device were successfully performed in a bovine model." The number of bovine subjects is not specified.

Data Provenance: The testing appears to be internal validation testing conducted by Inari Medical, Inc. The data is prospective in nature, as it was generated specifically for the purpose of demonstrating device performance and substantial equivalence. The country of origin of the data is not specified but would likely be the USA, given the FDA submission.

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

This information is not provided in the document. The non-clinical testing and animal study do not typically involve human expert readers establishing "ground truth" in the same way clinical image analysis studies would. Instead, performance is measured against engineering specifications, standard protocols, and physiological outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical and animal testing, not a study involving human readers or subjective interpretations that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This concept is not applicable to this device. The Infusion Aspiration Catheter System is a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI is irrelevant.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical and animal studies was established through:

• Engineering Specifications: For tests like tensile strength, burst pressure, flow rate, leakage, etc., the ground truth is predefined and measurable physical and mechanical properties.
• Validated Standards: Compliance with ISO standards (e.g., ISO 10555-1, ISO 594-1/2, ISO 10993-1, ISO 11607-1/2) serves as the "ground truth" for many tests.
• Simulated Conditions: For simulated use tracking, the "ground truth" is the successful and consistent removal of simulated thrombus in a controlled, simulated vascular environment.
• Physiological Outcomes (Animal Model): For the bovine model, the ground truth would be the assessment of the device's acute safety and performance within a living system, likely based on observations of tissue damage, device functionality, and physiological response.

8. Sample Size for the Training Set

This information is not applicable. The Infusion Aspiration Catheter System is a physical device, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable, as it is a physical device and not an AI/ML algorithm.

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The EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.

The proposed EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. The EMBO-Plus Embolectomy Catheter is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system which allows injection of physician specified agents without the need to remove the guidewire. By providing two functions within the catheter the operator is able to remove fresh, soft emboli and thrombi from within the arterial system and synthetic arteriovenous dialysis fistulae without having to lose guidewire position.

The provided text describes a 510(k) premarket notification for the EMBO-Plus Embolectomy Catheter, a medical device. This document focuses on the device itself and its comparison to a predicate device, not on an AI system or software with acceptance criteria in the typical sense of a diagnostic or predictive model.

Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert consensus, MRMC studies, and ground truth establishment cannot be provided from the given text.

The text details the following for the physical device:

• Device Description: The EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. It is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system allowing injection of agents without guidewire removal.
• Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the arterial system and synthetic arteriovenous dialysis fistulae.
• Performance Data (for the device):
  • Biocompatibility testing: Conducted according to ISO/ASTM standards (e.g., ISO MEM Elution Assay, ASTM Hemolysis Assay, Complement Activation C3a and SC5b-9 Assay, Partial Thromboplastin Time, Thromboresistance Evaluation, Rabbit Pyrogen, Guinea Pig Maximization Sensitization, Acute Systemic Injection Test, Intracutaneous Reactivity Test, Pyrogen (LAL) Chromogenic).
  • In-vitro performance bench tests: Included Balloon Crossing Profile, Catheter Shaft Diameter, Guidewire Lumen Diameter, Catheter Shaft Markings, Balloon Working Diameter, Balloon Inflation/Deflation Time, Balloon Fatigue, Catheter Body Burst Strength, Catheter Bond and Tip Pull Strength, Catheter Torque Strength, Contrast Media Flow Rate, Adherent Clot Removal, Simulated Use/Flexibility/Kink, Radiopacity.
  • In-vivo animal model testing: Performed in accordance with 21 CFR Part 58 "Good Laboratory Practices for Nonclinical Laboratory Studies." Synthetic arteriovenous access grafts were surgically placed in ovine specimens, allowed to mature, and then a simulated procedure was performed on test and control comparator groups. Post-procedure animals were observed, and vessel and organ histology was completed to compare responses.

Acceptance Criteria and Device Performance (Based on Device Testing, Not AI Algorithm):

Information Not Applicable or Not Provided in the Text (Related to AI/Software):

1. Sample size for the test set and data provenance: Not applicable as this is a physical medical device, not an AI algorithm.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Device ground truth is established through physical and biological testing.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
5. Standalone (algorithm only) performance: Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the device, ground truth is established through validated physical (bench) and biological (biocompatibility, in-vivo animal model) test methods, comparing performance against established specifications and a predicate device.
7. Sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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