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Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.

The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque.

The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter.

An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separately.

The provided text is a 510(k) summary for the Berenstein Coil, a medical device. It describes the device, its intended use, and predicate devices. Crucially, it does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for evaluating device performance.

Therefore, I cannot fulfill your request for specific details regarding acceptance criteria and study data as this information is not present in the provided input. This document is a regulatory submission summary, not a detailed clinical study report or performance evaluation.

To answer your request, you would need a document that describes:

• The specific performance metrics and their acceptance thresholds.
• The design and results of a study (e.g., a clinical trial, a bench test, and animal study) that evaluated the device against those criteria.
• Details about the data used (sample size, provenance), expert involvement, and ground truth methodology.

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