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The ClearLumen Thrombectomy System is intended to break-up, remove/aspirate soft emboli and thrombus from the peripheral vasculature.

The ClearLumen Thrombectomy Device consists of a thrombectomy catheter, saline drive unit ("SDU") and waste collection bottles. The thrombectomy catheter is a multi-lumen 6F or 7F guide compatible, 135 cm in length and is used over the wire. The catheters have a 7 cm rapid exchange length. The device is intended for use with conventional 0.014″ guidewires. The proximal end of the catheter contains a polycarbonate hub that connects to the SDU and provides access to the infusion and aspiration lumens. The distal end of the catheter shaft is comprised of an atraumatic tip. The ClearLumen Catheter is connected to the battery operated SDU which allows for simultaneous lysing and aspiration of thrombus from the treatment site. The SDU contains a port for connection to a standard saline bag. The device uses a toggle switch to turn the pump on and off.

Here's an analysis of the provided text regarding the ClearLumen Thrombectomy System, focusing on the acceptance criteria and supporting studies.

Based on the provided 510(k) summary, the document does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding specific acceptance criteria, study methodologies (sample sizes, ground truth establishment, expert qualifications), or comparative effectiveness studies. The summary focuses on establishing substantial equivalence to predicate devices through non-clinical performance data.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document states, "Design verification testing confirmed that the ClearLumen device performs according to the stated intended use." However, no specific quantitative or qualitative acceptance criteria are provided within this summary.

Reported Device Performance:
The summary broadly claims that "Design verification testing confirmed that the ClearLumen device performs according to the stated intended use." This is a general statement and no specific performance metrics or data points are reported for characteristics like thrombus removal efficiency, time taken, safety parameters, or comparability to predicate devices.

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

The document mentions "Design verification testing" and "functional testing performed pursuant to Walk Vascular's [standard/protocol - cut off in the text]."

• Sample Size for Test Set: Not specified.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. This appears to be internal company testing, likely conducted within the US (where the company is based), but no explicit details are given. It is non-clinical testing, meaning it's not patient data.

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

• For non-clinical performance data, the concept of "ground truth established by experts" as typically applied in clinical studies (e.g., radiologists interpreting images) is not applicable in this context. The testing would have involved engineering and laboratory personnel verifying device specifications and performance against pre-defined engineering requirements. There is no mention of external clinical experts reviewing this non-clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Given that the testing is described as "Design verification testing" and "functional testing," an "adjudication method" in the sense of resolving discrepancies among human readers (like 2+1 or 3+1) is not applicable. This would involve standard engineering and quality control verification processes.

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

• No. The provided text explicitly states "Non-Clinical Performance Data" and describes these evaluations as "Design verification testing" and "functional testing." This indicates laboratory and bench testing, not clinical studies involving human readers or patient cases. Therefore, an MRMC study and effects of AI assistance are not relevant or discussed in this document.

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

• Not applicable. The ClearLumen Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, a "standalone" performance study for an algorithm is not relevant to this device.

7. The Type of Ground Truth Used

• For the non-clinical "Design verification testing" and "functional testing," the "ground truth" would be engineering specifications, performance standards, and established laboratory measurement techniques. For example, if testing flow rate, the ground truth is the measured flow rate compared to a defined specification. If testing thrombus removal, it would be the objective measurement of removed material against a target. No specific type of ground truth (e.g., pathology, outcomes data) is mentioned from clinical data, as this is non-clinical testing.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical thrombectomy system, not an AI/machine learning model. Therefore, there is no "training set" in the context of data for an algorithm.

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

• Not applicable. As above, there is no "training set" for this type of device.

Summary of Missing Information:

The provided 510(k) summary is very high-level regarding the performance studies. It serves to inform the FDA that design verification and functional testing were performed but does not delve into the detailed methodology, specific quantitative results, or the precise acceptance criteria used in those non-clinical tests. For a clinical device, especially one involving patient interaction, detailed clinical study data would be expected, which is not present in this non-clinical submission summary.

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The AngioJet XMI Catheter – Rapid Exchange is indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter.

The AngioJet XMI Catheter – Rapid Exchange is a 135 cm, 4.0 French, sterile, single-use catheter designed for removing thrombus from vascular conduits. High velocity saline jets directed back into the Catheter create a localized low-pressure zone at the distal tip (Bernoulli effect) that results in suction, break-up, and removal of thrombus through the exhaust lumen. The Catheter is designed to track over a 0.014" guidewire and through a 6 French high flow guide wire catheter (0.068 inch minimum internal diameter), which allows sufficient passage of the Catheter with adequate clearance for injection of standard contrast medical, if desired.

The provided text is a 510(k) summary for the AngioJet XMI Catheter - Rapid Exchange (XMI-RX). It explains that the device is substantially equivalent to a predicate device and outlines its intended use and a comparison of technological characteristics. However, the document does not contain details about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The summary focuses on demonstrating substantial equivalence to a predicate device (AngioJet LF140 Catheter under K972610), which is a regulatory pathway that often relies on demonstrating similar safety and effectiveness without necessarily conducting new clinical trials against specific performance metrics.

Therefore, I cannot populate the table or answer most of your questions based only on the provided text, as the information you are requesting is not present.

Here's a breakdown of what can and cannot be inferred from the provided text:

What can be inferred from the document:

• Device Performance: The document states the device is "indicated for use with the AngioJet System in breaking apart and removing thrombus from infra-inguinal peripheral arteries ≥2mm in diameter." This describes its intended function, but not specific quantitative performance metrics or acceptance criteria.
• Sample Size for Test Set and Data Provenance: Not mentioned.
• Number of experts and qualifications for ground truth: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not mentioned. The approval is based on substantial equivalence, not a direct clinical outcomes study with defined ground truth.
• Sample size for the training set: Not applicable and not mentioned.
• How ground truth for the training set was established: Not applicable and not mentioned.

However, to address the request as directly as possible based on the spirit of the questions and the limited information:

Given that this is a 510(k) submission and the conclusion states "substantially equivalent to the predicate device," the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are implicitly tied to demonstrating this substantial equivalence. This typically involves:

• Bench testing: To show mechanical and functional equivalence to the predicate.
• Biocompatibility testing: To demonstrate material safety.
• Sterilization validation: To ensure the device is sterile.

These tests are performed to demonstrate that the new device is as safe and effective as the predicate device. The "device performance" reported would be that it functions equivalently to the predicate in these various tests.

No information about specific quantitative acceptance criteria or results of such tests are detailed in the provided documents. The summary merely asserts that such comparisons were made and demonstrated equivalence.

Therefore, I cannot fully complete the table or answer the questions with specific data points as they are not present in the provided 510(k) summary.

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