(57 days)
The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from:
- upper and lower extremity peripheral arteries > 3.0 mm in diameter and
- upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.
When used with the AngioJet System, the XPEEDIOR Rheolytic Thrombectorny Catheter uses high velocity saline jets to percutaneously break-up and remove thrombus. These saline jets are contained within the Catheter and provide the suction that produces this effect.
This document is a 510(k) premarket notification for the AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter, seeking to expand its indications for use. It outlines the device, its function, and the justification for the expanded indications. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial report would.
Here's an analysis based on the provided text, addressing your points where possible, and highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical study. This 510(k) is focused on expanding the indications for use of an already cleared device. The "Supporting Information" section states: "Applicable preclinical and clinical experience supports the expanded indications for use." This implies that data exists, but it is not detailed within this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly stated in the provided text. While "preclinical and clinical experience" are mentioned, no specifics on sample size, study design (retrospective/prospective), or data provenance are given.
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)
This information is not provided. Since this is a 510(k) for an expanded indication of an existing device, a formal "ground truth establishment" process for a new diagnostic algorithm's test set is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not an AI device. The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is a mechanical device used to remove thrombus. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI device. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated. The supporting information mentions "preclinical and clinical experience," which could involve various types of data and endpoints related to thrombus removal and patient outcomes, but the specific "ground truth" used is not defined in this document.
8. The sample size for the training set
This is not an AI device, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This is not an AI device, so there is no "training set" or establishment of ground truth for a training set in this context.
Summary of what the document does provide regarding the device and its expansion:
- Device Name: AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter
- Intended Use (Expanded): For use with the AngioJet System in breaking apart and removing thrombus from:
- Upper and lower extremity peripheral arteries > 3.0 mm in diameter
- Upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter
- Comparison to Predicate Devices: No design, packaging, sterilization, or other device change was required to expand the indications for use. The predicate devices are listed as AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter (K040013, K052256, and K061951).
- Basis for Expansion: "Applicable preclinical and clinical experience supports the expanded indications for use."
Conclusion:
The provided document is a 510(k) summary for an expanded indication of a mechanical medical device, not a report on an AI-powered diagnostic tool. Therefore, many of the requested details related to acceptance criteria, sample sizes, ground truth establishment, and AI study methodologies are not present in this type of regulatory submission. The FDA grants substantial equivalence based on the provided "preclinical and clinical experience" and the comparison to legally marketed predicate devices, rather than a detailed report of a specific study meeting predefined acceptance criteria for a novel device or AI algorithm.
§ 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).