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Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.

The Straumann Healing Abutments, Healing Caps, and Closure Screws are intended for use with the implants of the Straumann Dental Implant System (SDIS) to protect the inner features of the implant and to maintain, stabilize and form the soft tissue during the healing process. The devices are available in various diameters and heights. They are also not intended for use in immediate loading protocols; none of the devices of the Straumann Sterile Healing Solution are indicated for use in immediate loading protocols as they are intended to protect the internal features of the implant during the healing phase. When the implant has sufficient primary stability, the closure caps and fixation caps are used as a means to retain a bone graft used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.

The document provided is a 510(k) premarket notification for a medical device called "Straumann Sterile Healing Solution." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on studies involving AI or complex performance metrics typically associated with diagnostic algorithms.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML or a complex diagnostic system. The document focuses on material, design, and intended use comparison to an existing predicate device for dental implants and associated healing components.

Specifically, the following points from your request cannot be addressed from the given text:

• A table of acceptance criteria and the reported device performance: This document doesn't provide such data. The performance data section refers to sterilization, biocompatibility, and shelf-life validation, not performance metrics for an AI-enabled device.
• Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI model is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI model or ground truth establishment process described.
• Adjudication method (e.g. 2+1, 3+1, none) 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: The document explicitly states "No animal or human clinical studies were conducted."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• The type of ground truth used (expert concensus, 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.

The document is primarily a regulatory submission demonstrating substantial equivalence based on material, construction, and intended use, rather than performance validation data of an AI-driven or complex diagnostic device.

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