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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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