(20 days)
The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the Angiojet Ultra Console to break apart and remove thrombus from:
upper and lower extremity peripheral arteries ≥ 3.0mm in diameter,
upper extremity peripheral veins ≥ 3.0mm in diameter,
ileofemoral and lower extremity veins ≥ 3.0mm in diameter,
A-V access conduits ≥ 3.0mm in diameter and
for use with the Angiojet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console.
Here's an analysis of the provided text based on your request:
It's important to note that the provided document (K091593) is a 510(k) summary for medical devices (AngioJet® Ultra DVX® and Xpeedior® Thrombectomy Sets). It describes hardware devices, not a software/AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI device's performance metrics (like accuracy, sensitivity, specificity) and a ground truth established by experts are not directly applicable here.
Instead, this summary focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing, material comparisons, and similar indications for use.
Let's break down why most of your requested points cannot be directly answered from this document, and what can be inferred:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for a hardware device in 510(k)): The acceptance criteria here are implicitly related to demonstrating that the device performs as intended and is as safe and effective as its predicate devices. This is achieved through various forms of testing.
- Reported Device Performance: The document states: "Representative samples of the device underwent mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics."
| Characteristic/Test Category | Acceptance Criteria (Implied) | Reported Performance (Implied) |
|---|---|---|
| Safety | Device must not pose undue risk to patients or users. (e.g., maintain structural integrity, appropriate material biocompatibility, etc.) | "Mechanical bench testing to demonstrate safety..." (The results are not detailed in this summary but would be found in the full 510(k) submission, confirming the device met safety benchmarks.) |
| Effectiveness/Functionality | Device must perform its intended function of breaking apart and removing thrombus without significant issues. (e.g., proper fluid dynamics, catheter integrity, pump function) | "...and effectiveness and appropriate functional and performance characteristics." (Again, specifics are not in this summary, but the full submission would detail tests confirming successful thrombus removal, catheter durability, and pump function within specified parameters, consistent with predicate devices.) |
| Materials | Materials must be appropriate for the intended use and biocompatible. | "...similarities in functional design, materials, indications for use, and principles of operation" to predicate devices. (Implies materials are comparable and meet established standards.) |
| Indications for Use | Must align with predicate devices or be adequately justified. | Identical or very similar Indications for Use as predicate devices: break apart and remove thrombus from specific peripheral arteries/veins and A-V access conduits, and for use with the Power Pulse Kit. |
| Principles of Operation | Must be comparable to predicate devices. | "...similarities in functional design, materials, indications for use, and principles of operation." (Implies the mechanism of action for thrombectomy is the same as the predicate devices.) |
Lack of Specifics for AI-focused questions:
The remaining questions (2-9) are designed for evaluating AI/software performance in a diagnostic or predictive context. This document, being for a physical medical device, does not contain the information needed to answer them.
- 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for an AI algorithm here. Bench testing uses representative device samples.
- 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. No ground truth established by experts for AI output here.
- 4. Adjudication method: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. An MRMC study is for evaluating human performance, often with and without AI assistance. This device is a tool, not a diagnostic AI.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
- 7. The type of ground truth used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks against which the bench testing is measured.
- 8. The sample size for the training set: Not applicable. This is not an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
In summary: The K091593 document describes a medical device (a thrombectomy set), not an AI algorithm. Therefore, the detailed questions about acceptance criteria, test sets, ground truth, and expert evaluation pertinent to AI or software are not addressed in this type of submission. The "study" proving its acceptance is the "mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics" and comparison to predicate devices, but the specifics of that testing are not provided in this summary.
§ 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).