FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

AngioJet Solent Proxi Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Proxi Thrombectomy Set is used with the AngioJet Ultra Console.

AI/ML Overview

The provided text is a 510(k) summary for the AngioJet Solent Proxi Thrombectomy Set. It describes the device, its intended use, and lists various performance tests conducted. However, it does not provide specific quantitative acceptance criteria or detailed results to demonstrate that the device meets those criteria. It also doesn't describe the studies in the way requested in the prompt, focusing instead on the types of tests performed rather than the methodology and specific outcomes against acceptance thresholds.

Given the information available in the document, I can only address the questions to the extent possible. Much of the information requested (such as sample sizes for test sets, ground truth establishment for training and test sets, number/qualifications of experts, adjudication methods, and MRMC studies) is not present in this regulatory submission for a medical device that acts mechanically rather than using AI/machine learning.

Here's an attempt to answer the questions based only on the provided text, with explicit notes where information is not available:

Table of acceptance criteria and the reported device performance

The document lists the types of performance tests conducted but does not specify quantitative acceptance criteria or the reported performance values against those criteria. It only states that "Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use."

Acceptance Criterion (Not specified in document)	Reported Device Performance (No specific data reported)
e.g., Biocompatibility: No cytotoxicity	"Biocompatibility" testing was performed.
e.g., Leak testing: No leaks observed	"Leak testing" was performed.
e.g., Clot removal: X% efficacy	"Clot removal" testing was performed.
e.g., Hemolysis: Y% reduction	"Hemolysis" testing was performed.

Sample sizes used for the test set and the data provenance
- Sample Size: Not specified in the document for any of the performance tests.
- Data Provenance: The studies were internal "Bench and laboratory testing" conducted by MEDRAD Interventional / Possis. No information is given regarding country of origin or whether the data was retrospective or prospective, though for bench testing, these terms are less relevant than for clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device, not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation. The "ground truth" for mechanical performance tests would be based on validated measurement techniques and specifications.
Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on medical images or diagnoses, which is not relevant for the type of device and testing described.
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 device is an AngioJet Solent Proxi Thrombectomy Set, a mechanical thrombectomy device, and is not an AI/ML-based diagnostic or assistive software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a physical medical device (thrombectomy set) that requires human operation, not a standalone algorithm.
The type of ground truth used

For the performance data listed (biocompatibility, leak testing, clot removal, hemolysis, etc.), the "ground truth" would be established by:
- Standardized Test Methods: Using recognized international (e.g., ISO, ASTM) and internal test protocols with predefined acceptance criteria.
- Physical Measurements: Quantifiable measurements from bench and laboratory tests (e.g., tensile strength, temperature, fluid dynamics).
- Analytical Chemistry/Biology: Results from biocompatibility assays (e.g., cytotoxicity, sensitization, hemocompatibility assays).
The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established

Not applicable. No training set is involved for this type of device.

Summary

Regulation Number and Section

§ 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).