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Bashir™ Endovascular Catheter: The Bashir™ Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Bashir™ N-X Endovascular Catheter: The Bashir™ N-X Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids into the peripheral and pulmonary artery vasculature.

Thrombolex developed the Bashir™ Endovascular Catheter (Model 7201) to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The Bashir™ N-X Endovascular Catheter (Model 7200) is a second model developed for infusion of physician-specified fluids in the pulmonary artery. The Bashir™ N-X differs from the Bashir™ Endovascular Catheter in that the infusion limbs do not expand into an infusion basket but remain collapsed in a straight configuration. The two device models have a different appearance, namely in the handle design and color, which ensures appropriate use and identification.

The design of the Bashir™ Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. The physician-specified solution is then delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ Endovascular Catheter. After the completion of solution delivery, the infusion limbs are collapsed to a straight position in the case of peripheral vasculature, and then the Bashir™ Endovascular Catheter is retracted into the sheath and removed.

The handle of the Bashir™ N-X Endovascular Catheter has been modified to disable expansion of the basket. The Bashir™ N-X Endovascular Catheter, unexpanded, is thus similar to other straight infusion catheters including the predicate device.

Delivery of the Bashir N-X™ Endovascular Catheter into the pulmonary artery is accomplished using a long guide sheath using standard interventional techniques. The Bashir™ Endovascular Catheter is placed over a guidewire inside the sheath to the desired location under fluoroscopic guidance. The catheter does not come in direct contact with the right atrium, tricuspid valve, right ventricle or pulmonic valve at any time, as it is within a guide sheath.

The Bashir™ Endovascular Catheter and Bashir™ N-X Endovascular Catheter are comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.

The provided text describes the Bashir Endovascular Catheter and Bashir N-X Endovascular Catheter and their substantial equivalence to a predicate device, the Ekosonic Endovascular System. However, it does not contain information about acceptance criteria or a study that uses a standalone AI algorithm, or a multi-reader, multi-case comparative effectiveness study with human readers.

Based on the provided text, the following information can be extracted regarding the device performance and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for any of the performance tests. The text mentions "participants" for human factors testing and a "GLP porcine study" but does not quantify the number of subjects/samples.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. The animal study is described as a "GLP porcine study," implying a prospective, controlled study conducted under Good Laboratory Practice regulations.

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 studies described are primarily bench, animal, and usability tests, not diagnostic accuracy studies that would typically involve expert-established ground truth. Expert involvement is implied in assessing usability criteria and potentially in interpreting animal study results, but no specifics are given.

4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (bench, animal, usability), formal adjudication methods like 2+1 or 3+1 (common in diagnostic accuracy studies) would not typically be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or described. The document focuses on demonstrating substantial equivalence of a medical device (catheter) through bench, animal, and usability testing, not on evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm study was not done. The device is a mechanical endovascular catheter, not an AI algorithm.

7. Type of Ground Truth Used

• Bench Testing: Ground truth is established by physical measurements, engineering specifications, and validated test methods (e.g., verifying flow rates against expected values, measuring device dimensions, checking for leaks).
• Animal Study: Ground truth is established by physiological and pathological assessments in the porcine model (e.g., absence of systemic or pathological adverse effects).
• Human Factors Testing: Ground truth is established by predefined acceptance criteria for task performance and user feedback, evaluated against the device's intended use.

8. Sample Size for the Training Set
This is not applicable as the device is a mechanical catheter and does not involve AI or machine learning algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a mechanical catheter and does not involve AI or machine learning algorithms that require a training set.

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The Octane aspiration system is intended for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.

The Octane aspiration system consists of two components: the Octane catheter and the Octane hand pump. The Octane aspiration catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F, guidewires ≤ 0.018" in diameter, and it is intended for use in vessels ≥ 3 mm in diameter. The catheter has a rapid exchange design and includes sliding, co-axial inner and outer lumens. The catheter inner lumen tip has three side wall slot ports and the catheter's outer lumen has a beveled radiopaque tip. To alleviate plugging of the catheter tip caused by thrombus, the actuator on the proximal end of the catheter slides the catheter's outer lumen back and forth over the inner lumen distal tip. The actuator on the proximal end of the catheter is also used to control the directionality of the torque-able catheter. Directionality is further achieved through the gradual curve in the shaft materials at the distal end. The Octane hand pump provides suction to the inner lumen of the Octane aspiration catheter and is manually operated using a spring-loaded handle. It consists of a pump handle fitted with a 30ml piston syringe, tubing, a series of one-way valves, and a 500ml collection bag. The hand pump tubing has a standard luer fitting for connection to the Octane aspiration catheter hub. The Octane aspiration system has been sterilized with ethylene oxide.

This document is a 510(k) Summary for the Octane Aspiration System, a medical device intended for the removal of embolic material from blood vessels. The summary describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (Pronto XL). However, it does not contain information about acceptance criteria and device performance in a format that directly addresses the user's request for AI/algorithm-related performance metrics or human reader studies.

The document specifies bench testing and biocompatibility testing to demonstrate substantial equivalence, focusing on the physical and material properties of the device, rather than the diagnostic or interpretative performance of an AI system.

Therefore, many of the requested categories related to AI performance, ground truth, expert opinions, and sample sizes for AI training/testing sets cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, it does not provide a specific table detailing the numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the tests performed.

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

• The document does not specify sample sizes for each bench or biocompatibility test. These tests typically involve a certain number of device units.
• Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided as these are bench and lab tests, not clinical or image-based studies.

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

• This is not applicable. The studies described are physical and material tests of a medical device, not diagnostic or AI-driven interpretations requiring expert consensus for ground truth.

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

• This is not applicable. These are objective engineering and laboratory tests, not subjective interpretations requiring adjudication.

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 MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported in this document. The device is an aspiration catheter, not an AI diagnostic tool.

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

• No standalone algorithm performance study was done as the device is a physical medical instrument, not an AI algorithm.

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

• The "ground truth" for the bench tests would be established by engineering specifications, physical measurements, and standardized laboratory procedures. For biocompatibility, it's defined by the ISO 10993 standards. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.

8. The sample size for the training set:

• Not applicable, as this device does not involve an AI algorithm that requires a training set.

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

• Not applicable, as this device does not involve an AI algorithm.

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