(29 days)
The SmartClaw™ Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature.
The SmartClaw™ Thrombectomy Catheter is a mechanical thrombectomy catheter designed to work with commercially available sheaths sized 8F or larger. The device consists of an inner catheter shaft, outer catheter shaft, heat set nitinol braid, and an actuation handle attached to the proximal ends of the shafts. There are two device configurations that differ only in length of the expandable nitinol braided basket. The two configurations are identified by the maximum diameter of the expanded basket (20 mm, 32 mm).
The SmartClaw™ Thrombectomy Catheter is introduced through a commercially available sheath sized 8F or larger and delivered to the targeted vessel location under fluoroscopy and standard endovascular techniques using a commercially available guidewire. After it is delivered to the targeted vessel location, the catheter's distal nitinol basket is expanded by moving the handle slider proximally. Fluoroscopic guidance is used to ensure the expanded basket achieves a 1:1 ratio with the vessel diameter. Subsequently, the SmartClaw™ Thrombectomy Catheter is retracted proximally to pull loosened clot towards the sheath. Then, the clot is removed from the patient via aspiration or another commercially available clot removal method as appropriate for procedure requirements. After the clot is removed, the catheter's distal nitinol basket is collapsed, and the SmartClaw™ Thrombectomy Catheter is withdrawn from the targeted vessel location through the sheath.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "SmartClaw™ Thrombectomy Catheter." This type of document is a regulatory submission for a device that is substantially equivalent to a predicate device, meaning it's not a new groundbreaking technology, but rather a modification or similar version of an already cleared device.
Therefore, the document does not describe a study that would establish new acceptance criteria or prove device performance in a clinical setting in the way an AI/software device would. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing and packaging validation).
Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for an AI device study:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported clinical device performance in the way an AI study would (e.g., sensitivity, specificity, AUC). Instead, it discusses bench testing performance criteria.
| Acceptance Criteria (from Bench Testing) | Reported Device Performance |
|---|---|
| Visual inspection | Conforms |
| Dimension requirements | Conforms |
| Mechanical integrity | Conforms |
| Fluid leakage | Conforms |
| Kink resistance | Conforms |
| Torsion | Conforms |
| Guidewire compatibility | Conforms (0.035 in guidewire) |
| Sheath compatibility | Conforms (8F or larger) |
| Packaging integrity (ISO 11607-1, -2) | Conforms |
The general statement for all bench tests is "The results of these tests demonstrate the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing."
2. Sample sized used for the test set and the data provenance
The document only mentions "performance evaluations" and "testing" for bench tests. It doesn't specify sample sizes for these tests, nor does it refer to "test sets" in the context of clinical data. Data provenance (country of origin, retrospective/prospective) is not applicable or provided as this is a physical device submission based on non-clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there is no clinical "test set" or "ground truth" derived from expert review in the context of an AI algorithm's performance. The "ground truth" for the non-clinical tests would be the established engineering specifications and standards.
4. Adjudication method for the test set
Not applicable, as there is no clinical test set requiring expert adjudication.
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 a physical medical device (catheter) and not an AI/software device. Therefore, no MRMC study or AI assistance effect size is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the "ground truth" would be the engineering specifications, design parameters, and relevant ISO standards (e.g., ISO 11607-1 and ISO 11607-2 for packaging).
8. The sample size for the training set
Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI algorithm.
In summary:
This FDA 510(k) submission is for a physical medical device, not an AI software. The "study" referenced is a series of non-clinical bench tests and packaging validations, intended to demonstrate the device's physical integrity and functionality, and its substantial equivalence to a previously cleared predicate device. It does not involve patient data, clinical outcomes, or expert review for diagnostic accuracy, which would be typical for an AI/software device submission. The acceptance criteria are engineering and performance specifications, not clinical performance metrics like sensitivity or specificity.
§ 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).