(84 days)
The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System
- in breaking apart and removing thrombus from infrainguinal peripheral arteries >3.0 mm in diameter; and/or
- with the AngioJet Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System. The AngioJet System is intended for mechanical throbectomy removal. The Power Pulse Spray Ancillary Kit enables the AngioJet Xpeedior 120 Catheter to deliver a pulsed infusion of a physician-specified fluid to a local treatment area during a peripheral intervention.
The provided text is a 510(k) premarket notification for the AngioJet Xpeedior 120 Catheter. This document is for a medical device that physically removes thrombus (blood clots), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set" in the context of AI/SaMD do not apply to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device, as typically required for 510(k) submissions.
Here's an analysis based on the information provided, reinterpreting some questions for a physical medical device context where possible:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device and not an AI/SaMD, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering specifications, safety, and functional performance, rather than diagnostic accuracy metrics. The document states:
- Device Description: "The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System. The AngioJet System is intended for mechanical thrombectomy removal."
- Intended Use: "The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System... in breaking apart and removing thrombus from infrainguinal peripheral arteries ≥3.0 mm in diameter; and/or... with the AngioJet Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system."
- Functional and Safety Testing: "The Xpeedior 120 Catheter is nearly the same device as identified K040013. Therefore, the testing listed in K040013 is sufficient to determine that the subject device is suitable for its intended use."
The document implicitly indicates that the device meets the functional and safety requirements by asserting substantial equivalence to the predicate device K040013, which would have undergone its own testing. Explicit "acceptance criteria" and "reported performance" metrics for this device are not detailed in the provided text, as this is a summary of the 510(k) rather than the full submission with detailed test reports.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/SaMD and does not use a "test set" in the context of evaluating an algorithm's performance on data. The evaluation relies on the device itself being "nearly the same" as a previously cleared device. Any clinical data or bench testing related to the predicate device (K040013) would have been used for its clearance, but details are not provided here for this specific submission (K052256).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth for a test set" is established as this is not an AI/SaMD.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method for a test set" is mentioned as this is not an AI/SaMD.
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 not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" is used as this is not an AI/SaMD. The evaluation is based on engineering principles and substantial equivalence to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD and does not use a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD and does not use a "training set" or "ground truth" in that context.
§ 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).