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Delivery of restorative and impression material.

The PermaRidge syringe is a device used for the delivery of restorative and impression material. It is composed of a plastic barrel, polypropylene plunger, and rubber plunger tip.

This 510(k) summary for K962838 concerns a medical device (syringe) and not an AI/ML-driven diagnostic or assistive technology. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, ground truth, and AI performance metrics is not applicable to this submission.

The 510(k) summary provided describes a simple physical device called the "PermaRidge syringe" intending to deliver restorative and impression material. The evaluation for such a device typically focuses on:

• Material biocompatibility: Ensuring the materials used are safe for patient contact.
• Sterilization efficacy: Verifying the device can be effectively sterilized without compromising its integrity.
• Functional performance: Confirming the syringe can reliably deliver the intended materials without leakage, premature discharge, or other mechanical failures.
• Comparability to predicate devices: Demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.

The document states, "Comparison of Product Characteristics: 6, The PermaRidge syringe consists of a plastic (cellulose acetate propionate) barrel, polypropylene plunger, and rubber plunger tip." This suggests the primary mechanism for demonstrating safety and effectiveness was likely a comparison of materials and design to existing, approved syringes (predicate devices).

Therefore, it is impossible to provide the requested information in the format of an AI/ML study because this document describes a conventional medical device, not an AI/ML system.

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