(174 days)
The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. The LimFlow Vector consists of a 4Fr intravascular catheter that has a working length of 120cm. It utilizes a deployment mechanism to deploy the self-expanding nitinol cutting basket mounted at distal tip which self-centers in the vessel to prevent the cutting blades from damaging the vessel wall. The size of the cutting basket and cutting blades adjust to the internal diameter of the vein as the LimFlow Vector is being drawn through the vessel. The LimFlow Vector is compatible with 0.018" standard guide wires. The LimFlow Vector is used in a healthcare facility, such as a catheter lab or hospital. It is in contact with patient tissue for less than 24 hours. The LimFlow Vector is supplied sterile.
The provided text is a 510(k) summary for the LimFlow Vector device. It outlines the device description, intended use, comparison to a predicate device, and performance data. However, it does not include the specific details required to answer your questions thoroughly, particularly regarding acceptance criteria, the statistical design of a study proving the device meets those criteria (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).
The document focuses on engineering performance tests and biocompatibility, as commonly required for a 510(k) submission for certain device types. It does not describe a clinical study in the format typical for AI/ML device evaluations where performance is measured against human experts or a gold standard on a medical imaging dataset.
Therefore, I cannot extract the information you've requested from the provided text because it is not present. The document lists performance tests such as:
- Dimensional verification
- Simulated Use
- Tensile Strength testing
- Flexibility and Kink resistance
- Torque Strength
- Radiopacity
- Corrosion resistance
- Particulate Evaluation
- Luer and Leak Testing
- Shelf-life Testing
- Sterilization Validation
- Packaging Validation
- Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, PTT, Complement Activation, Thrombogenicity)
- Pre-clinical studies in swine and cadaveric models.
These are primarily engineering and bench-testing parameters, not the clinical performance metrics (like sensitivity, specificity, AUC) typically associated with AI/ML systems evaluated against image-based ground truth established by experts.
There is no mention of:
- A table of acceptance criteria with reported device performance in the context of AI/ML metrics.
- Specific sample sizes for a 'test set' or 'training set' for an AI model.
- Data provenance (country of origin, retrospective/prospective) for a clinical dataset.
- Number/qualifications of experts for ground truth or adjudication methods.
- MRMC studies to evaluate human reader improvement with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used as pathology or outcomes data for clinical performance.
In summary, the provided FDA 510(k) summary is for a physical medical device (valvulotome) and details its engineering and biocompatibility testing, not the evaluation of an AI/ML component.
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).