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The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure

The ExFeel® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. ExFeel® implant Fixture Systems consist of one-stage, rootform dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are ExFeel® Implant Fixtures, Retained Restoration Abutment System.

The provided text is a 510(k) summary for the "ExFeel® IMPLANT SYSTEMS." It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or analytical validation with human subjects or AI algorithms.

Instead, this document focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) based on design, materials, intended use, and laboratory testing for functionality and conformance to design input requirements. This is a common approach for medical devices cleared through the 510(k) pathway, where a direct comparison to a predicate device often fulfills the regulatory requirement for demonstrating safety and effectiveness without requiring extensive new clinical trials.

Therefore, I cannot provide the requested information because it is not present in the given text. The text explicitly states:

• "13-8. Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements" - This indicates engineering/bench testing, not clinical performance acceptance criteria against human data or AI performance.
• "13-12. Basis for Substantial Equivalence The Exfeel Implants are substantially to ITI Dental Implant(K002374), Nobel Biocare Branemark Dental Implant(K993595) in intended use, material and design." - This highlights the primary method of demonstrating safety and effectiveness.

To explicitly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to "laboratory testing... to determine device functionality and conformance to design input requirements," but it does not specify what those criteria were or detail the results in a performance table.
2. Sample size used for the test set and the data provenance: Not applicable, as there is no human test set or data described. The "test set" here would refer to the physical implants subjected to laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical or image-based AI studies is not relevant to this type of submission.
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 device is not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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