Search Results

The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.

The NeuroEdge™ Infusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroEdge™ Infusion Catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid agents (such as contrast media and liquid embolic glues) through the end hole at select sites in the neurovasculature for the diagnosis, visualization, and treatment of arterio-venous malformations/fistulas (AVM/AVF's), lesions, or embolisms. The catheter is also designed to penetrate an embolism if it is determined to be a soft thrombus and navigate through the thrombus to assess the circulation distal to the thrombus.

The NeuroEdge™ Infusion Catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized via gamma radiation sterilization process.

The provided document describes a 510(k) submission for the NeuroEdge™ Infusion Catheter, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might see for a novel device.

Therefore, the document does not contain specific acceptance criteria, performance metrics, or details about a study designed to prove the device meets those criteria in the way a clinical trial report would. Instead, it focuses on demonstrating that the new device is "substantially equivalent" to existing devices.

Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fully answered by this document:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that performance testing was done, but does not provide specific numerical acceptance criteria (e.g., minimum flow rate, maximum burst pressure, specific clinical success rates) or the quantitative results from those tests. The "reported device performance" is a general statement that the tests support safety and performance.

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

• Sample Size: Not specified. The document mentions "performance testing" but does not detail the number of units tested or the number of cases/patients involved in any clinical or simulated use tests.
• Data Provenance: Not specified. Given the nature of a 510(k) for a device like this, the performance testing would typically involve bench testing (in-vitro) and potentially some animal studies, rather than human patient data, unless specifically required based on the predicate device or unique risks. The document does not indicate if any human data was used, retrospectively or prospectively.

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

• Number of Experts: Not applicable/not mentioned. "Ground truth" in the context of expert review for medical imaging or diagnostic devices is not relevant here. The performance testing would be engineering or laboratory-based, assessing physical properties and functional aspects of the catheter against design specifications, not expert interpretation of clinical data.
• Qualifications of Experts: Not applicable/not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/not mentioned. Adjudication methods (like 2+1, 3+1 consensus) are used when multiple human readers interpret ambiguous clinical data to establish a ground truth. This is not the type of study described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. These studies are typically conducted for diagnostic imaging devices to assess the impact of AI on human reader performance. The NeuroEdge™ Infusion Catheter is a delivery device (catheter) for diagnostic, embolic, and therapeutic agents.

• Effect Size of Human Readers with vs. without AI Assistance: Not applicable. This device does not incorporate AI for diagnostic assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study: Not applicable. This device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance study was performed.

7. Type of Ground Truth Used:

• Type of Ground Truth: For the "performance testing," the "ground truth" would be the engineering specifications and validated test methods. For example, if testing catheter flexibility, the ground truth would be a defined acceptable range of flexibility. If testing flow rate, the ground truth would be a specified flow rate under certain conditions. The document does not provide details on these specific ground truths or specifications.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

In summary: The provided document is a 510(k) submission, which focuses on demonstrating "substantial equivalence" of the NeuroEdge™ Infusion Catheter to legally marketed predicate devices. It mentions "performance testing" was conducted to verify design specifications and support safety and performance, but it does not provide the specific details (acceptance criteria, methodologies, sample sizes, or results) of these tests that would be required to answer most of your questions in the context of a detailed study report for a novel medical device or AI system.

Ask a specific question about this device

The NeuroVasx Sub-Microinfusion Catheter is intended for the delivery of diagnostic agents into the neurovasculature.

The NeuroVasx Sub-Microinfusion Catheter is a single use, 1.4 Fr device designed to fit within a standard microcatheter for advancement to, and navigation of a lesion site. A nitinol mandrel within the NeuroVasx catheter lumen facilitates axial movement and stability during navigation. The catheter is designed to infuse liquid diagnostic agents radially through side holes in the wall of the catheter to improve the diffusion and mixing of the infused agent with the blood flow.

The NeuroVasx catheter is contained in a plastic hoop assembly and sealed in a Tyvek / polyester pouch. The sealed pouch assembly is labeled and placed in a shelf carton along with the instructions for use, and then sterilized in a gamma radiation sterilization process.

The provided document is a 510(k) summary for the NeuroVasx Sub-Microinfusion Catheter, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/algorithm performance, is not present.

However, based on the available text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen for AI device evaluations. Instead, it states that "Design verification testing was performed to verify that the NeuroVasx catheter met the design specifications and performance requirements." It then reports a high-level outcome: "The results of the comparative and design verification testing confirmed that the NeuroVasx catheter performs as well or better than the predicate devices tested and is suitable for use; no new questions of safety and effectiveness were raised."

Implicit acceptance criteria would likely be related to the design specifications and performance requirements for safe and effective delivery of diagnostic agents into the neurovasculature, including:

• Mechanical Integrity: Ability to withstand forces during navigation and infusion without failure.
• Dimensions: Adherence to specified dimensions (e.g., 1.4 Fr) to fit within standard microcatheters.
• Infusion Capability: Effective and controlled radial infusion of liquid diagnostic agents.
• Biocompatibility: Materials used must be safe for contact with human tissue and blood.
• Sterility: Ability to be sterilized via gamma radiation.
• Ease of Use: Facilitation of axial movement and stability during navigation.

Reported Device Performance:

• Performs "as well or better than the predicate devices tested."
• "Suitable for use."
• "No new questions of safety and effectiveness were raised."
• "All materials passed biocompatibility testing and are suitable for this application."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Design verification testing" and "comparative and design verification testing" but does not specify any sample sizes for these tests. It also does not mention any human data or clinical study in terms of data provenance (e.g., country of origin, retrospective or prospective). The testing described appears to be primarily bench testing and material compatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the submission describes a physical medical device and its bench testing, not an AI or diagnostic algorithm requiring expert-established ground truth from clinical images or data.

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

This information is not applicable as there is no expert adjudication process described for establishing ground truth in this device's evaluation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI systems on human reader performance, which is not the subject of this 510(k) submission for a physical infusion catheter.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not a software algorithm.

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

The concept of "ground truth" as typically understood in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The "truth" or reference standard for this device's performance would be against established engineering design specifications, material standards, and performance characteristics consistent with its intended function and predicate devices. For biocompatibility, the ground truth would be established scientific standards and tests.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not provided. There is no "training set" for this physical device.

Ask a specific question about this device