Search Results

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.

Ask a specific question about this device