(51 days)
The Excipio LV Thrombectomy Device indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels.
The Excipio LV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device. The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (10-25mm in diameter). The thickness of the basket wires enhance the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.
The provided text describes the Excipio LV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance. The document is a 510(k) summary for a medical device which focuses on non-clinical testing for safety and performance compared to existing devices.
Therefore, most of the requested information regarding AI/algorithm performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "The in vitro bench tests demonstrated that the Excipio LV Thrombectomy Device met all acceptance criteria and performed similarly to the predicate device." and "Performance data demonstrate that the device functions as intended and has a performance profile that is similar to the predicate devices."
The acceptance criteria themselves are not explicitly detailed as numerical values or specific thresholds in this document. Instead, they are implied to be met by the successful execution and results of the listed non-clinical tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical/Physical Performance | The device met all acceptance criteria and performed similarly to the predicate device for tests including: Visual Inspection, Dimensional Inspection, Kink Resistance, Torsional Strength, Tensile Testing, Simulated Use, and Corrosion Testing. Performance data demonstrate that the device functions as intended and has a performance profile similar to predicate devices. |
| Material/Biological Performance | The device was found to be biocompatible, demonstrating conformance with tests including: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute System Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, and Thrombogenicity. |
| Functional Performance | Clot removal testing was performed, and performance data demonstrate that the device functions as intended and has a performance profile similar to predicate devices. |
| In-vivo Safety (Animal Study) | The device was safe to use in the peripheral veins in the acute swine model as evidenced by no perforations, transmural dissections, or gross thrombosis or emboli, and patent vessels after treatment when assessed by the physician in the blood vessel venographically and through histopathology. |
Regarding the AI-specific questions:
- Sample size used for the test set and the data provenance: Not applicable; this document does not describe a study involving a test set for AI/algorithm performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the animal study, the ground truth was established by
physician venographic assessment and histopathology. For the bench tests, the ground truth was based onengineering and material science standards/measurements. - The sample size for the training set: Not applicable; this document does not describe a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).