Search Results

The Cerenovus Large Bore Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.
The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.

The provided text does not describe an acceptance criteria study for an AI/ML-enabled device but rather a 510(k) submission for a physical medical device (Cerenovus Large Bore Catheter and Aspiration Tubing Set). Therefore, much of the requested information regarding AI/ML device performance (like expert consensus, adjudication methods, MRMC studies, training/test set details) is not applicable or present in the document.

However, I can extract the relevant acceptance criteria and performance data for the mechanical device as found in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" for this context:
For physical medical devices, "acceptance criteria" for performance testing typically refer to specific measurable thresholds or ranges that the device must demonstrate to confirm its functionality and safety. While the exact numerical values for these criteria are not explicitly stated in this summary, the document indicates that pre-established criteria exist and were met ("Samples met the established acceptance criteria").

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

• Sample size: Not explicitly stated in the summary. The document mentions "samples" in the plural form were tested for each performance test.
• Data provenance: Not explicitly stated. The testing ("Performance Testing - Bench") was conducted by Cerenovus, Inc. as part of their 510(k) submission.

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

• Not applicable. This pertains to AI/ML device evaluations. For a mechanical device, performance is typically measured against engineering specifications and industry standards, not expert-established ground truth in the same manner as image interpretation or diagnosis.

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

• Not applicable. This pertains to AI/ML device evaluations.

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. This pertains to AI/ML device evaluations. The device mentioned is a physical catheter and aspiration set, not an AI-assisted diagnostic tool.

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

• Not applicable. This pertains to AI/ML device evaluations.

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

• Bench Testing / Engineering Specifications: For this mechanical device, the "ground truth" or reference for performance is established by engineering specifications, validated test methods, and potentially industry standards (e.g., ISO, ASTM for material properties, fluid dynamics). The specific parameters measured (flow rate) are compared against pre-defined acceptable ranges.

8. The sample size for the training set:

• Not applicable. This pertains to AI/ML device evaluations. This device is not an AI/ML model that requires training data.

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

• Not applicable. This pertains to AI/ML device evaluations.

Ask a specific question about this device

The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA are candidates for treatment.

The CERENOVUS® Aspiration Tubing Set is intended to connect the CERENOVUS Large Bore Catheter to the canister of the NOUVAG Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.

The CERENOVUS Large Bore Catheter can be connected to the NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump) using the CERENOVUS® Aspiration Tubing Set.

The provided text describes a 510(k) premarket notification for a medical device (CERENOVUS Large Bore Catheter and Tubing Set), which focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance, animal, sterilization, shelf-life, and biocompatibility testing. It does not include information about AI/ML device performance, human reader studies, or the establishment of ground truth by expert consensus. Therefore, I cannot generate a response that fulfills the requirements of the prompt regarding acceptance criteria for an AI/ML device or studies proving its performance.

The document is purely about a physical medical device and its mechanical/physical/biological properties, not an AI/ML diagnostic or assistive technology.

Ask a specific question about this device

The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices.

The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopague marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing and insertion of catheters. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.

Here's the information about the acceptance criteria and the study proving the device meets them, based on the provided text:

Note: The provided document is a 510(k) summary for a medical device (CERENOVUS Large Bore Catheter). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy in the same way a new drug or high-risk device might. Therefore, the "study" described is primarily a series of bench tests and biocompatibility assessments, not clinical trials comparing device performance with and without AI, or studies involving human experts for ground truth establishment. Many of the specific points requested (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study effect size, standalone performance, training set details) are generally not applicable or not reported in this type of document for a Class II percutaneous catheter.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document repeatedly states "Samples met the established acceptance criteria" for bench tests. While the exact number of samples for each test is not explicitly given, it mentions, "All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures." For biocompatibility, some tests specify the number of animals (e.g., mice for systemic toxicity, rabbits for pyrogenicity, 3 for "In Vivo Thromboresistance Study - Jugular Vein").
• Data Provenance: The studies are bench testing (in-vitro physical and mechanical tests) and biocompatibility testing (in-vitro and some in-vivo animal tests).
  • Country of Origin: Not specified, but likely performed by or for Codman & Shurtleff, Inc. (Raynham, MA, USA).
  • Retrospective or Prospective: These were prospective tests conducted specifically for this 510(k) submission.

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

• Not Applicable. The device is a physical medical instrument (catheter), not an AI or diagnostic device that relies on expert interpretation for ground truth. "Ground truth" in this context is established by objective measurements based on engineering specifications and international standards (e.g., ISO, USP).

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not a study requiring human adjudication for diagnostic ground truth. The acceptance is based on objective measurements and compliance with specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance was not performed and is not relevant to this submission.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Objective Measurements and Compliance with International Standards:
  • Bench Testing: Engineering specifications (e.g., dimensions, strength, flow rates), and compliance with international standards such as ISO 10555-1 and related test methods.
  • Sterilization: ISO 11135-1 and requirements for Ethylene Oxide residuals per EN ISO 10993-7 for SAL of 10⁻⁶.
  • Biocompatibility: ISO 10993-1, specific parts of ISO 10993 for various tests (e.g., cytotoxicity, sensitization, irritation), and USP limits for pyrogenicity.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in this context refers to the development and manufacturing process based on established engineering principles.

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

• Not Applicable. As above, no training set in the AI sense. The design and manufacturing processes are validated against established engineering and quality control standards.

Ask a specific question about this device