(14 days)
The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.
Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.
This is a premarket notification (510(k)) for a medical device, the AngioJet Ultra Spiroflex VG Thrombectomy Set, not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device evaluations (such as acceptance criteria for AI performance metrics, sample size for AI test sets, expert ground truth, MRMC studies, or training set details) is not applicable or present in this document.
The document describes the device, its intended use, and states that it underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, and comparative testing to demonstrate appropriate functional and performance characteristics.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Design | Similar to predicate devices |
| Materials | Similar to predicate devices |
| Indications for Use | Similar to predicate devices |
| Principles of Operation | Similar to predicate devices |
| Mechanical Testing | Passed (demonstrated appropriate functional and performance characteristics) |
| Biocompatibility | Passed |
| Sterility | Passed |
| Comparative Testing | Passed (demonstrated appropriate functional and performance characteristics) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "Representative samples of the devices underwent bench testing."
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The testing was laboratory/bench-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert interpretation for ground truth. Testing involved engineering and analytical methods.
4. Adjudication method for the test set:
- Not applicable. Testing was based on engineering and performance standards, not expert adjudication of diagnostic outcomes.
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. This is not an AI/ML device; an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a thrombectomy set, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's evaluation would be defined by established engineering specifications, material standards, sterility standards, and functional performance benchmarks consistent with the predicate devices. It is not an "expert consensus," "pathology," or "outcomes data" in the AI/ML sense.
8. The sample size for the training set:
- Not applicable; this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable; this is not an AI/ML device.
§ 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).