(66 days)
The Xtract® Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
The Xtract Catheter System consists of one (1) Catheter, one (1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, and one (1) 40µm Strainer. The catheter is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter. It has a distal radiopaque tip marker, a varying stiffness shaft, a rapid exchange port, and a proximal luer-lock hub.
The provided text is a 510(k) summary for the Xtract Catheter System, detailing its intended use and a comparison to a predicate device for substantial equivalence. It does not contain information about a study proving device performance against specific acceptance criteria. The summary states that "The results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device," but it does not describe the specific acceptance criteria, study design, or its results in detail.
Therefore, I cannot provide the requested table or detailed study information based on the provided document.
To directly address the prompts based on the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided document. The document states that "the results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device." This implies that the acceptance criteria were based on demonstrating equivalence to the predicate device (LBI Aspiration Catheter, K053372) rather than explicit performance metrics.
- Reported Device Performance: Not detailed in the provided document. The document only states that the in vitro bench and biocompatibility testing confirmed equivalence to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the provided document. The document only mentions "in vitro bench and biocompatibility testing," without detailing sample sizes, data provenance, or study design.
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 as the document describes bench and biocompatibility testing, not clinical studies involving expert interpretation or ground truth establishment in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the type of testing described (bench and biocompatibility).
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. The Xtract Catheter System is a medical device (catheter), not an AI-powered diagnostic tool. The document does not describe any MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The Xtract Catheter System is a medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The document describes in vitro bench and biocompatibility testing, where "ground truth" would be defined by engineering specifications and biological response standards, not clinical diagnostic ground truth methods.
8. The sample size for the training set
- Not applicable. The document describes testing for a medical device's equivalence to a predicate, not an AI model's training.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).