(10 days)
The Trellis™-8 Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The Trellis-8 Peripheral Infusion System enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit that oscillates the Dispersion Wire within the isolated region to further disperse the infused fluid. If desired by the physician, post procedure aspiration of the isolated area between the occluding balloons may be accomplished through the catheter by using the guidewire lumen.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Trellis-8 Peripheral Infusion System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through clinical trials or performance studies in the way a pharmaceutical or novel high-risk device might.
Therefore, the document does not contain the detailed information typically found in a study report designed to rigorously quantify device performance against pre-defined acceptance criteria, especially not for AI/ML-driven diagnostics.
Based on the information provided in the 510(k) Summary (page 4), here's what can be extracted and why other requested information is not available:
1. Table of acceptance criteria and reported device performance:
The document states: "The Trellis-8 Peripheral Infusion System was tested in the same manner as the Trellis Reserve. All components, subassemblies, and/or full devices met the required specifications for the completed tests."
- Acceptance Criteria (Implicit): That "all components, subassemblies, and/or full devices met the required specifications" as established for the predicate device, Trellis Reserve Infusion System (K032261), and as designed under Bacchus Vascular's Quality System, which complies with 21 CFR. Specific numerical or qualitative acceptance criteria (e.g., burst pressure, flow rate deviation limits, etc.) are not detailed in this summary.
- Reported Device Performance: The summary states that the device "met the required specifications for the completed tests." No specific performance metrics or values are reported.
Summary of available information for Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| All components, subassemblies, and/or full devices meet the required specifications as established for the predicate device (Trellis Reserve Infusion System K032261) and as designed under Bacchus Vascular's Quality System (21 CFR compliant). | "All components, subassemblies, and/or full devices met the required specifications for the completed tests." |
Regarding the other requested information:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This information is not provided. The 510(k) summary mentions "Testing Summary" but does not detail sample sizes, test types (e.g., in-vitro, in-vivo, clinical), or data provenance. Since this is a device for fluid infusion, testing would likely involve bench testing (e.g., material compatibility, structural integrity, flow rates) rather than human clinical data for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided. For a device like the Trellis-8 Peripheral Infusion System, "ground truth" in the diagnostic or AI sense (e.g., confirmed diagnosis by experts) is not relevant. Performance is typically measured against physical and engineering specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not detailed in this 510(k) summary.
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 information is not applicable/provided. MRMC studies are specific to diagnostic tools, especially those involving AI/ML interpretation. The Trellis-8 Peripheral Infusion System is an infusion system, not a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable/provided. This device does not feature an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or basis for evaluation) for this device would be established engineering specifications derived from relevant standards, risk analysis, and performance of the predicate device. It would not involve expert consensus, pathology, or outcomes data in the sense of diagnostic accuracy.
8. The sample size for the training set:
- This information is not applicable/provided. This device does not involve AI or machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
- This information is not applicable/provided. As above, there is no AI or associated training set.
In summary, the provided document is a 510(k) clearance letter for a medical device (Trellis-8 Peripheral Infusion System), indicating its substantial equivalence to a predicate device. It does not include detailed study results, acceptance criteria, or ground truth methodologies that would be typical for an AI/ML-enabled diagnostic device or a study designed to rigorously quantify performance against explicit criteria in a clinical setting. The "study" mentioned is a general statement that the device was tested to meet "required specifications" similar to its predicate.
§ 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).