(191 days)
The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.
The IVS Clip Closure System consists of an extravascular implantable nitinol clip mounted on an Introducer Sheath. A clip applier acts to release the clip into vascular tissue where it closes vascular puncture wounds.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IVS Clip Closure System:
The provided document (K020879 510(k) summary) does not detail specific quantitative acceptance criteria or a dedicated clinical study with performance metrics for the IVS Clip Closure System. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Angiolink EVS™ Vascular Closure System) through technological characteristics and general testing.
Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance are not available in this document.
The document indicates that "Testing: The IVS Clip Closure System has been tested in vitro, in vivo and in human model systems. Test results show that the device is safe and effective for the intended use." This is a general statement about the testing performed, but it lacks specific details about performance metrics against acceptance criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance |
|---|---|
| Safety | "Test results show that the device is safe and effective for the intended use." |
| "All components which contact the fluid path or tissue are biocompatible in accordance with ISO Standard 10993." | |
| Effectiveness for intended use | "Test results show that the device is safe and effective for the intended use." |
| "Performance testing of the IVS system demonstrates that there are no new issues of safety or effectiveness associated with this difference [in clip material]." | |
| Substantial Equivalence to Predicate | "The IVS Clip Closure System is substantially equivalent to the Angiolink EVS™ Vascular Closure System." |
| Biocompatibility | "All components which contact the fluid path or tissue are biocompatible in accordance with ISO Standard 10993." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The document mentions "in vitro, in vivo and in human model systems" but does not give specific numbers for these tests or delineate a "test set" in a statistically rigorous sense for performance metrics.
- Data Provenance: Not specified in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. The document does not describe a process for establishing ground truth via expert review for performance against specific metrics. The evaluation is focused on substantial equivalence and general safety/effectiveness.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication method: Not applicable/not specified.
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
- MRMC Study: Not applicable. This device is a mechanical closure system, not an AI-assisted diagnostic or interpretation tool. The concept of "human readers improve with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a mechanical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly defined in terms of a specific "ground truth" used for performance metrics. The demonstration of safety and effectiveness appears to be based on:
- Biocompatibility testing (against ISO Standard 10993).
- Functional testing (in vitro, in vivo, human model systems) to demonstrate the device performs its intended function (tissue approximation, hemostatic closure) and that the design differences (nitinol clip vs. titanium staple, clip/carrier on introducer sheath) do not introduce new safety/effectiveness issues.
- Comparison to a predicate device for substantial equivalence rather than establishing de novo performance against a "ground truth" outcome.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. This is a mechanical device, not a machine learning model.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.