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Visioplast Acrylic Resin is a resinous material for repairing cranial defects.

Visioplast Acrylic Resin is a self-curing resin which is intended for the repair of cranial defects. Like the predicate model, the proposed acrylic resin is provided sterile and contains a liquid and powder component. Visioplast Acrylic Resin is designed for manual mixing technique. When the two components are mixed together, a viscous paste is obtained which hardens within 20 minutes with a cold-curing polimerisation. The chemical constituents are substantially equivalent to those in the predicate apart from the presence of barium sulphate in the powder which provides radiopacity for imaging purposes.

The provided text does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. The document is a 510(k) premarket notification for a medical device (Visioplast Acrylic Resin) and focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria.

The information available from the text is limited to:

• Device Name: Visioplast Acrylic Resin
• Intended Use: Repairing cranial defects.
• Equivalence: Substantially equivalent to Codman Cranioplastic TM, Acrylic Cranioplasty Material (#K873689).
• Key Feature: Contains barium sulphate for radiopacity.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth. These types of details are typically found in a clinical study report or a more comprehensive technical file, which is not part of this 510(k) summary.

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