(73 days)
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.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).