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

The ClearLumen Thrombectomy System consists of a thrombectomy catheter, saline drive unit ("SDU") and aspirate collection vacuum bottles. The 6 Fr, 135 cm, multi-lumen thrombectomy catheter delivers pressurized saline, within the distal catheter I.D., to assist in the break-up and removal of soft emboli and thrombus. The distal catheter's .014″ wire compatible rapid exchange lumen extends and ends in a soft atraumatic tip. The catheter's proximal polycarbonate hub connects to the SDU and provides coaxial access to the infusion and aspiration lumens. The ClearLumen Catheter is connected to the battery operated SDU, which includes a pump to generate pressurized saline and conduit/collection of aspirate. The SDU uses a toggle switch to turn the pump on and off and actuate a valve in line to a pre-charged vacuum bottle (aspiration source). The SDU connects via spike to a standard saline bag (saline source).

The provided text describes a 510(k) premarket notification for the ClearLumen Thrombectomy System, establishing its substantial equivalence to predicate devices based on non-clinical and clinical performance data.

Here's the information requested, extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate devices and meeting pre-determined product specifications and external standard requirements. The reported device performance indicates that all testing conducted met these criteria. Specific quantitative acceptance criteria or precise numerical performance targets are not explicitly detailed in the provided summary.

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

• Test Set (Human Clinical Study):
  • Sample Size: 20 subjects
  • Data Provenance: Prospective, single-center human clinical study. The country of origin is not explicitly stated, but clinical trials for FDA submissions are often conducted in the US or in countries with an ethical and regulatory framework comparable to the US.

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

The document does not explicitly state the number of experts or their qualifications who established the ground truth for the test set (human clinical study). The study endpoints (Myocardial Blush Grade (MBG) and Thrombolysis In Myocardial Infarction (TIMI) flow grade) are typically determined by cardiologists or interventional radiologists reviewing angiographic images.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set's clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, nor any discussion of AI assistance or its effect size on human reader performance. This device is a mechanical thrombectomy system, not an AI diagnostic tool.

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

This question is not applicable as the device is a medical instrument (thrombectomy system), not a software algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For In-Vitro Testing: Ground truth was based on pre-determined product specifications and external standard requirements, as well as accepted engineering and biological testing methodology (e.g., ISO standards for biocompatibility and sterilization).
• For In-Vivo (Animal) Study: Ground truth was based on observed safety and performance metrics in the animal model.
• For Human Clinical Study: Ground truth was based on clinical outcomes data, specifically:
  • Myocardial Blush Grade (MBG) ≥ 2
  • Final Thrombolysis In Myocardial Infarction (TIMI) flow grade = 3
  • Absence of Major Adverse Coronary Events (MACE)
  • Absence of device-related Significant Adverse Events (SAE)
    These are objective clinical endpoints typically assessed by trained medical professionals.

8. The Sample Size for the Training Set

The document describes a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than training a novel algorithm. Therefore, there is no mention of a "training set" in the context of device development or evaluation for this thrombectomy system. The studies described are for verification and validation.

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

As there is no mention of a "training set" for this device, this question is not applicable.

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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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