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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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Berenstein Coils are intended for the embolization of vascular malformations of the 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 separatelv.

The provided text describes a medical device (Berenstein Coil) and its equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria as typically understood in the context of AI/ML or diagnostic device performance.

The document is a 510(k) summary for a Class III medical device (Berenstein Coil). It focuses on demonstrating "substantial equivalence" to existing predicate devices, rather than establishing specific diagnostic performance metrics (like sensitivity, specificity, AUC) against a defined ground truth.

Therefore, I cannot provide a response based on your requested structure, as the necessary information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, or training set details is not present in the provided text.

The "Testing in Support of Substantial Equivalence Determination" section describes:

• In-vitro, in-vivo, and biocompatibility testing: These are general categories of testing to ensure safety and effectiveness comparable to predicate devices.
• Functional bench testing:
  • Force required to deliver coils through catheters.
  • Coil/catheter compatibility.
    These are engineering/design validation tests, not clinical performance metrics against a ground truth.

In summary, the provided text does not contain the type of study data (e.g., diagnostic accuracy metrics against a ground truth, reader study results) that your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic devices would typically require.

Ask a specific question about this device