(252 days)
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.
| Performance Test Category | Device Performance (Conclusion) |
|---|---|
| Bench and Laboratory Testing | Results provide assurance that the proposed device conforms to the requirements for its intended use and supports a determination of substantial equivalence to the predicate device. Specific tests performed include: Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogen, Physiochemical), Hemocompatibility (ASTM Hemolysis, Partial Thromboplastin Time Assay, C3a Complement Activation, SC5b-9 Complement Activation, Thromboresistance), Package integrity, Sterilization testing, Dimensional testing, Operational characteristics, Aspiration testing, Tracking, Mechanical integrity, Kink resistance. |
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.
§ 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).