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The StarClose™ Vascular Closure System is intended for use 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 StarClose™ Vascular Closure System is designed to deliver a nitinol clip to close vascular puncture sites to achieve hemostasis.

The provided text is a 510(k) summary for the Abbott Vascular Devices IVS Clip Closure System (StarClose™ Vascular Closure System) and the associated FDA approval letter. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the device itself.

Therefore, much of the requested information (acceptance criteria, detailed study design, sample sizes for training/test sets, ground truth methodology, expert qualifications, adjudication methods, MRMC study results, and standalone performance) is not present in the provided text. The submission is based on non-clinical testing to demonstrate equivalence, not a clinical trial to prove specific performance against pre-defined acceptance criteria in a human population.

However, I can extract the information that is available:

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

This information is not provided in the given text. The 510(k) summary states, "Substantial equivalence was confirmed through non-clinical testing," but does not detail the specific non-clinical tests, their acceptance criteria, or the reported performance outcomes.

2. Sample sized 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 in the given text, as the approval is based on "non-clinical testing" which does not involve a human patient test set.

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):

This information is not provided in the given text, as the approval is based on "non-clinical testing" which does not involve human experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the given text.

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 provided in the given text. The StarClose™ Vascular Closure System is a medical device for closing vascular puncture sites, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

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

This information is not provided in the given text. The StarClose™ Vascular Closure System is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not provided in the given text. For "non-clinical testing," ground truth would likely be established through engineering specifications, material properties, and experimental measurements against known standards, but these specifics are not detailed.

8. The sample size for the training set:

This information is not provided in the given text. The submission refers to "non-clinical testing," not machine learning model training.

9. How the ground truth for the training set was established:
This information is not provided in the given text. The submission refers to "non-clinical testing," not machine learning model training.

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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

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.

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