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The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

The SwissPlant Dental implant system consists of implants, abutments, healing components, fixation screws and surgical armamentaria for use in one or twostage placement and restorations.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for a dental implant system. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not detail any performance studies against specific acceptance criteria.

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The Tapered Screw-Vent®, Screw-Vent®, AdVent®, and Zimmer® One-Piece 3.7 mm Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.

The purpose of this submission is to add an immediate loading single tooth indication to the following implants systems previously cleared by FDA: Tapered Screw-Vent, Screw-Vent (K013227), AdVent (K011245) and Zimmer One-Piece 3.7 mm (K052997). These implants are titanium alloy, self-tapping implants that incorporate either the MTX or MP-1 surface. There is no significant difference in design or materials between the implants in this submission and the previously cleared implants from Zimmer Dental.

The provided document describes the 510(k) premarket notification for the Zimmer Dental Implants - Immediate Loading Indication. It is primarily a declaration of substantial equivalence to previously cleared devices, rather than a detailed study demonstrating performance against specific acceptance criteria for a novel device.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be fully extracted from this document, as it focuses on demonstrating equivalence rather than a de novo performance study.

Here's what can be inferred and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The basis for clearance is substantial equivalence to predicate devices. The "performance" reported is that the "Zimmer Dental Implants - Immediate Loading Indication have the following similarities to the predicate devices":

• Same intended use
• Same operating principle
• Same basic design
• Same materials
• Packaged and sterilized using the same materials and processes.

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

Not applicable. This is a 510(k) for substantial equivalence based on product design and material similarities to previously cleared devices, not a performance study with a test set of data.

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. There is no mention of a test set requiring expert ground truth establishment.

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

Not applicable. There is no mention of a test set or adjudication process.

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 not an AI/software device, and no MRMC study is mentioned.

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

Not applicable. This is a medical device (dental implants), not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a learning algorithm or a study requiring data collection for training.

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

Not applicable. See point 8.

Summary based on the provided document:

The Zimmer Dental Implants - Immediate Loading Indication received 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices (Tapered Screw-Vent, Screw-Vent, AdVent, and Zimmer One-Piece 3.7 mm Implants, and Nobel Biocare TiUnite Dental Implants).

The "acceptance criteria" and "performance" described are qualitative similarities in:

• Intended use
• Operating principle
• Basic design
• Materials
• Packaging and sterilization methods

No specific clinical studies with defined quantitative acceptance criteria, test sets, or expert evaluations are detailed in this 510(k) summary for the immediate loading indication, as the submission relies on the established safety and effectiveness of the predicate devices.

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