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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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The Simpler Toadstool Mini Implant is intended to be used as an artificial root to provide immediate long term or transitional support for overdentures.

The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. These implants may also be used for temporary soft tissue overdenture support for partial and fully edentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentuloism as an alternative to more invasive surgery involving conventional implants.

The Simpler Toadstool Minis and the Simpler HA Toadstool Minis are Narrow Diameter implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4% vanadium for strength. All implants are arit blasted and also acid etched and are available uncoated or coated with hydroxylapatite only on the threaded part of the implant. The diameter is 2.5mm and the lenaths are 10mm. 13mm, 15 mm and 18 mm in both the coated and uncoated implants. The implants are designed as one piece with a flattened toadstool shaped abutment with a hexagonal outline at the top of the implant. The flattened, hex ball fits into a keeper with a rubber o-ring placed in the prosthesis to reduce loading and to help with retention.

The provided document describes a 510(k) premarket notification for an endosseous dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies as often seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert consensus, and comparative effectiveness studies is not applicable or cannot be extracted from this document.

However, I can extract the relevant information from the provided text based on the nature of this submission.

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission concerning an endosseous dental implant, "acceptance criteria" are typically related to material properties, mechanical performance, and substantial equivalence to predicate devices, rather than clinical efficacy metrics like sensitivity or specificity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not describe a clinical "test set" in the context of an AI/ML algorithm evaluation. It's a 510(k) for a physical medical device (dental implant). The "Summary of Testing" section indicates that "Simpler Toadstool Mini Implants do not introduce new issues for materials, surface treatment, fatigue testing and risk management that have not been addressed in all other approved Simpler Implants." This implies equivalence through comparison to existing data and established parameters of the predicate devices. There is no mention of a specific new clinical study with a test set of human subjects described in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical dental implant, not an AI/ML device requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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

Not applicable. This is about a physical implant, not an AI/ML system assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's safety and effectiveness essentially relies on:

• Established engineering and material science principles: for the titanium alloy, surface treatment, and design.
• Performance of predicate devices: The primary "truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The new device demonstrates substantial equivalence to these.
• Existing knowledge of dental implant outcomes: The contraindications and complications listed are general to dental implants, implying a reference to broad clinical experience.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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