Search Results

GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

GEISTER vessel dilators

This is a 510(k) premarket notification for a medical device (GEISTER Vessel Dilators), not a study report for an AI/ML device. Therefore, the document does not contain information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI/ML study.

The document is an FDA letter stating that the GEISTER Vessel Dilators are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. It outlines the regulatory classification, product code, and indications for use of the device.

To directly answer your request based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not contain information relevant to an AI/ML device study. It is a 510(k) clearance letter for a Class II surgical vessel dilator and discusses substantial equivalence to predicate devices, not performance against specific acceptance criteria in a study format typically associated with AI/ML.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: Not applicable for this type of document.
• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device