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The Excipio® SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels.

Device Description

The Excipio SV Aspiration Catheter and Tubing consists of an aspiration catheter which is a single, large inner lumen catheter with a hydrophilic coating (20cm outside the distal end) designed to navigate through the peripheral vasculature and provide the maximum luminal area for aspiration. The aspiration catheter will be available in 7F and 8F sizes. Sterile, single use aspiration tubing will be distributed to facilitate a vacuum connection between the aspiration catheter and the collection canister of the vacuum pump.

AI/ML Overview

Since the provided text describes a medical device (catheter and tubing) rather than an AI/ML powered device, the requested information (such as sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) is not applicable or available in the document.

The document discusses the non-clinical testing performed to establish substantial equivalence of the Excipio SV Aspiration Catheter and Tubing to a predicate device.

Here's a summary of the available information based on the provided text, focusing on the acceptance criteria and performance data for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests/Assessments	Reported Device Performance
Excipio SV Aspiration Catheter	Visual Inspection	Met all acceptance criteria
	Dimensional Inspection	Met all acceptance criteria
	Kink Resistance (material property)	Met all acceptance criteria
	Torsional Strength	Met all acceptance criteria
	Tensile Testing	Met all acceptance criteria
	Functional Testing: Vacuum Collapse	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Kink Resistance	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Torque Testing	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Tip Pull	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Proximal Shaft to Luer	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Coating Length	Performed similarly to the predicate device, functioned as intended
	Coating Integrity	Met all acceptance criteria
	Particulate Testing	Met all acceptance criteria
Tubing	Dimensional Inspection	Met all acceptance criteria
	Tensile Testing	Met all acceptance criteria
	Functional Testing: Vacuum Collapse	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Kink Resistance	Performed similarly to the predicate device, functioned as intended
System-level Testing	Simulated Use Testing	Performed similarly to the predicate device, functioned as intended
	Visual Inspection	Met all acceptance criteria
	Tubing Testing	Met all acceptance criteria
	Packaging and Sterile Barrier Testing	Met all acceptance criteria
Biocompatibility (Catheter)	Cytotoxicity, Sensitization, Irritation, Acute System Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity	Results showed the device to be biocompatible
Biocompatibility (Tubing)	Cytotoxicity, Sensitization, Irritation	Results showed the device to be biocompatible
GLP Animal Study (Porcine)	In vivo thrombogenicity, acute performance, and safety	Usable, non-thrombogenic, raised no new safety questions

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not specified for individual bench tests. The animal study was conducted using a "porcine model," but the number of animals is not provided.
Data Provenance: The "non-clinical laboratory testing" and "in vitro bench tests" were performed, indicating laboratory-generated data. The "GLP animal study (porcine)" indicates live animal data. Countries of origin are not specified for these tests. The data appears to be prospective as it was performed to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The testing described involves objective physical and biological measurements, not expert interpretation of outputs like in AI/ML performance evaluation.

4. Adjudication Method

This information is not applicable and not provided. The testing described involves objective measurements against predefined criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to this medical device submission.

6. Standalone Performance

The document describes "Non-Clinical Testing/Performance Data" and "in vitro bench tests" which evaluate the device's performance properties as a standalone product (i.e., algorithm only without human-in-the loop performance). The animal study also evaluated standalone performance in an in-vivo setting.

7. Type of Ground Truth Used

The "ground truth" for this device type is established by:
- Engineering specifications and standards: For dimensional, strength, and functional tests (e.g., kink resistance, tensile strength, vacuum collapse).
- Validated biological assays: For biocompatibility tests (e.g., cytotoxicity, hemolysis).
- In-vivo observations and measurements: For the GLP animal study (e.g., thrombogenicity, acute performance, safety).

8. Sample Size for the Training Set

This information is not applicable and not provided. There is no AI/ML component described, so no 'training set' is used.

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

This information is not applicable and not provided, as there is no AI/ML component or training set.

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