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Lifecore's implants 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 terminal or intermediate abutment support for fixed bridgework.

The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Lifecore Dental Implants are root-form, endosseous implants with a roughened surface. The modification proposed in this submission will modify the Resorbable Blast Media (RBM) implant surface to add a micro-texture surface morphology to the existing macrotexture. The change to the RBM surface will be incorporated into all Lifecore implant systems that have the RBM surface (Restore, Stage-1, Renova, PrimaSolo and PrimaConnex).

The provided text describes a 510(k) submission (K072768) for Lifecore Biomedical, Inc.'s dental implants with a surface modification. However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study (sample sizes, ground truth establishment, expert qualifications, etc.) that would prove the device meets such criteria.

The submission is a Special 510(k) for a surface modification, meaning the primary focus is on demonstrating substantial equivalence to a predicate device, not necessarily on new performance studies with quantitative acceptance criteria against reported performance metrics in the same way a de novo device might.

The document mainly focuses on:

• Identifying the submitter and device.
• Describing the device and the proposed surface modification (adding a micro-texture to existing macrotexture on RBM implants).
• Stating the intended use.
• Asserting substantial equivalence to predicate devices based on identical intended use, biocompatible materials, design, shelf life, packaging, and sterilization.
• The FDA's decision letter confirming substantial equivalence.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets these criteria, as this information is not present in the provided text.

The text does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for a test set, data provenance, or details of any specific study used to prove performance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size for human readers.
6. Information on standalone algorithm performance.
7. The type of ground truth used (pathology, outcomes data, etc.).
8. The sample size for a training set.
9. How ground truth for a training set was established.

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