Search Results

The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

The Fetch 2 Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi. Its outer diameter (0.056" or 4F) allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located near the distal tip. Fetch 2 is provided with an extension line (connected to a one-way stopcock), 2 - 30 cc syringes, and 2 - 40 micron collection baskets. The baskets can be used to filter aspirated blood for laboratory analysis of collected thrombus.

The provided document is a 510(k) premarket notification for the Fetch 2 Aspiration Catheter. This document does not describe a study involving an AI-powered device or an algorithm's performance. Instead, it focuses on demonstrating the substantial equivalence of the Fetch 2 Aspiration Catheter to a predicate device through bench and laboratory testing.

Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, etc.) is not applicable to this submission.

However, I can extract information related to the performance data and the conclusion regarding substantial equivalence for the medical device itself.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for each performance test in the same way an AI algorithm might have specific sensitivity/specificity targets. Instead, the submission relies on demonstrating that the device "conforms to the requirements for its intended use" and that its performance is "substantially equivalent" to the predicate device. The "reported device performance" is summarized by the successful completion of the listed tests.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each bench or laboratory test. It generally references industry standards (e.g., ISO, ASTM) which would dictate appropriate sample sizes for such tests.

Data Provenance: The testing appears to be conducted in a laboratory setting, likely in the US, as the submitter and contact person are based in Minneapolis, MN, USA. The data is prospective for this device's submission, meaning the tests were performed to support this specific 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI-powered device using expert-labeled image data. The "ground truth" for the device's performance would be established by the physical and chemical properties and functional outputs measured during the bench and laboratory tests, compared against established engineering and medical device standards.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or labeling of data that would require an adjudication method in this type of submission.

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 a medical device (aspiration catheter), not an AI algorithm intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the device performance tests listed, the "ground truth" is based on:

• Physical and Chemical Standards: Adherence to established material properties, dimensions, and manufacturing standards.
• Biological Standards: Compliance with biocompatibility and hemocompatibility standards (e.g., ISO 10993).
• Operational Standards: Measured functional performance parameters like aspiration efficiency, trackability, and mechanical integrity, likely compared against the predicate device's known performance or established functional requirements.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical device, not an AI model.

Ask a specific question about this device

The AngioJet Solent Proxi Thrombectomy Set is 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 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.

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:

1. 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.

2. 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.

3. 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.

4. 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.

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 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.

6. 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.

7. 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).

8. 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.

9. How the ground truth for the training set was established

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

Ask a specific question about this device