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The Simpler Toadstool Abutment consists of a pre-manufactured flattened ball which is directly screwed into a Simpler endosseous dental implant. The design allows for a lower profile height for a soft tissue supported overdenture. The prosthetic device is indicated for retention of soft tissue supported overdentures only and NOT for implant supported prostheses such as crowns and bridges.

The Toadstool abutment is a restorative prosthesis that threads into an already integrated dental implant. A rubber O ring snaps into a metal keeper, both of which are imbedded into a denture base. When in use, this rubber ring/keeper combination attaches the denture to the abutment preventing the movement of the denture while providing a cushioning affect to the implant.

It has a flattened ball at the top giving the retention area an ovoid appearance in profile. The external hexagonal portion of the abutment that allows the abutment to be torqued into the implant has been moved from below the ball at gingival level to the be part of the ovoid retention portion

The provided document is a 510(k) summary for the "Simpler Toadstool Abutment," a dental implant component. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set specifics.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria and Reported Device Performance (Table 1): The document does not define specific clinical acceptance criteria (e.g., success rates, complication rates, retention force ranges) for a clinical trial and does not report performance against such criteria. It states that the device has "proven safe and effective" by reference to predicate devices but doesn't provide new performance data. The only "test" mentioned is a non-clinical torquing load test, which is an engineering specification, not a clinical performance metric.
• Sample Size for Test Set and Data Provenance (2): No clinical test set is described. The "non clinical tests" mentioned involve the device itself, not human subjects or patient data.
• Number of Experts and Qualifications for Ground Truth (3): Ground truth is not established in the context of clinical performance as no clinical study or expert review of clinical outcomes is described.
• Adjudication Method (4): Not applicable, as there's no clinical test set requiring adjudication.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (5): Not applicable. This type of study would compare human performance with and without AI assistance, which is not relevant to a dental abutment's mechanical evaluation.
• Standalone Performance (6): The device's "performance" is primarily mechanical and related to its design modifications. It's not an AI algorithm with standalone performance in the typical sense. The torquing load test result could be considered a standalone mechanical performance, but it's not a comprehensive clinical performance metric.
  • Reported performance (from "NON CLINICAL TESTS"): The abutments were tested to a breaking limit of 113 to 120 NCm. This is well in excess of the recommended maximum torquing load of 30 NCm for insertion.
• Type of Ground Truth Used (7): For the non-clinical test, the "ground truth" is the physical measurement of the breaking limit under controlled laboratory conditions. There is no clinical ground truth established or needed for this type of submission.
• Sample Size for Training Set (8): Not applicable. There is no AI model or algorithm being "trained."
• How Ground Truth for Training Set was Established (9): Not applicable.

Summary of what is provided regarding testing:

The document mentions non-clinical tests directly related to the mechanical properties of the abutment:

• Test: Torquing load on abutments during insertion.
• Acceptance Criterion (implicit): The device should withstand torquing loads significantly higher than the recommended insertion torque.
• Reported Performance: The abutments were tested to a breaking limit of 113 to 120 NCm.
• Conclusion: This breaking limit is well in excess of the recommended torque load of 30 NCm.

This information demonstrates the structural integrity of the abutment under a specific loading condition but does not involve clinical performance, human subjects, or AI evaluations. The primary argument for substantial equivalence relies on the device's design similarities to already approved predicate devices and the fact that its modifications (flattened ball, hex relocation) do not raise new questions of safety or effectiveness.

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