(30 days)
The AXS Vecta® Intermediate Catheter is indicating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
The AXS Vecta Intermediate Catheter is a single lumen, flexible stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal end (distal 25cm) to reduce friction during use. It is packaged with one Scout Introducer, one hemostasis valve, and two peel-away introducers.
The Scout Introducer may be used in conjunction with the AXS Vecta Intermediate Catheter to facilitate in the introduction of the AXS Vecta Intermediate Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious hydrophilic coating at the distal end to reduce friction during use. The inner lumen of the AXS Vecta Intermediate Catheter is compatible with the Scout Introducer, guide wires and microcatheters. The inner lumen of the Scout Introducer is compatible with guide wires and microcatheters of an outer diameter of less than 0.044in.
The provided text describes the acceptance criteria and the study conducted for the AXS Vecta® Intermediate Catheter to demonstrate substantial equivalence to a predicate device, rather than a device proving novel acceptance criteria for AI/ML. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, ground truth type for test set, training set details) are not applicable to this submission.
However, I can extract information related to the device's performance testing against pre-determined acceptance criteria from the provided document.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "performance testing was conducted. The tests were performed using standard test methods and pre-determined acceptance criteria and all samples passed." It then provides a summary of the performance testing.
| Test Method Summary | Acceptance Criteria and Reported Device Performance |
|---|---|
| Visual Inspection (Packaging: Pouch Visual) | All units met the acceptance criteria and passed Packaging Visual Inspection |
| Visual Inspection (Packaging: Undamaged Product) | All units met the acceptance criteria and passed Packaging Visual Inspection |
| Tensile Strength | All units met the acceptance criteria and passed Tensile Strength testing. |
| PTFE Delamination | All units met the acceptance criteria and passed PTFE Delamination testing |
| Torque Strength | All samples met acceptance criteria and passed Torque Strength testing. |
| Catheter Burst | All samples met acceptance criteria and passed Catheter Burst testing |
| Leak (Liquid) | All samples met acceptance criteria and passed the Air and Liquid Leakage testing. |
| Leak | All samples met acceptance criteria and passed the Air and Liquid Leakage testing. |
| Dimensional (ID, OD, & Working Length) | All samples met acceptance criteria and passed Dimensional testing. |
| Kink Resistance | All samples met acceptance criteria and passed Kink Resistance testing. |
| Visual Inspection (Transition & Tip) | All samples met acceptance criteria and passed both the transition and tip visual inspections. |
| Tip Flexibility | All samples met acceptance criteria and passed Tip Flexibility testing. |
| Friction Force | All samples met acceptance criteria and passed Friction Force testing. |
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 does not specify the exact sample sizes for each test listed in Table 2. It generally states that "All units" or "All samples" met the criteria.
Data provenance is not explicitly mentioned as this is a bench testing and simulated-use study for a medical device's physical performance, not a clinical data study.
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)
Not applicable. This is not a study involving human expert interpretation for ground truth. The "ground truth" for these tests would be the established engineering specifications and performance standards for medical catheters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human adjudication of results.
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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI. The performance studies are for the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the performance testing is based on pre-determined acceptance criteria derived from standard test methods and engineering specifications relevant to percutaneous catheters. This is a form of engineering/technical specification ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device; there is no "training set."
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).