(25 days)
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:
- A table of acceptance criteria or reported device performance.
- Sample sizes for a test set, data provenance, or details of any specific study used to prove performance.
- Number or qualifications of experts used for ground truth.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size for human readers.
- Information on standalone algorithm performance.
- The type of ground truth used (pathology, outcomes data, etc.).
- The sample size for a training set.
- How ground truth for a training set was established.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.