(104 days)
The Regular Diameter Single Stage TPS Dental Implant System is indicated for use in support of crowns, bridges, or overdentures in completely and partially edentulous in support of orewnlo; and good es in areas with sufficient alveolar bone width and maxilliary and manufacturersed portion of the implant with at least 1mm of bone, both buccally and lingually.
The Regular Diameter Single Stage (RDS) TPS Dental Implant System consists of the The Regular Diameter Single Stage (RDB) 11 Sociated abutment systems, which single-stage, foot-form dental implants and associatined and overdentive instrument provide the clinician with certiently and restorative instrumentation: restorative options. The system also includes surgical and restorative instrumentation: restorative options. The system aloo included beath gauges, abutment drivers, and drivers, surgical taps, surgical depth problem and the implants, prosthetics, and drivers, open eno wrench and hallphouse dubtore. The clinitian to choose only those only those surgical tools are each packaged separately to . The cinning to singly m surgical tools are each packaged soparation. The single-stage implant is titanium. components required for each clinical situation. The single-stage The components required for each olimour of the implant that is submerged into bone. The problemant of enithelial plasma spray coated on the portion of the attachment of epithelial non-submerged portion is machined cimestin to allett for the second (uncovery) surgery that is required in two-stage implant systems.
This document describes the Lifecore Regular Diameter Single Stage (RDS) TPS Dental Implant System.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly established through a substantial equivalence comparison to predicate devices, rather than explicit numerical thresholds for performance metrics. The study aims to demonstrate that the subject device performs as safely and effectively as the predicate devices.
| Feature / Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Identical or highly similar intended use, materials, design, and surface characteristics to predicate devices. | The Lifecore RDS TPS Dental Implant System's intended use, materials (CP Titanium Grade 4), and design features (external screw threads, implant body diameter, shoulder diameter, collar height, lengths, one-stage design, locking taper interface, cutting flute, TPS coating, gamma sterilization) are compared directly to the ITI 4.1mm Solid Screw Implant and Accessories (K894595, K920768) and the Restore Self-Tapping Implant System (K924589). The document states that the intended use is "Identical to predicate devices" and that the "comparative analysis demonstrates the substantial equivalence." |
| Biocompatibility/Material Safety | Materials should be safe for implantation and demonstrate suitable performance. | CP Titanium (Grade 4) is used, matching one predicate (ITI) and being a higher grade than the other (Restore, Grade 3). Electrochemical Corrosion Evaluation and Galvanic Couple testing (Precious Alloy/CP titanium and Precious Alloy/Ti alloys in artificial saliva) were performed, and "All have been found to be within acceptable limits." |
| Mechanical Integrity | Device should be structurally sound and maintain its integrity under expected loads. | "Bending strength" was tested, and specifications "have been met." "Mechanical Properties of the Plasma Spray Coating have been analyzed," and "All have been found to be within acceptable limits." |
| Dimensional Accuracy | Device dimensions should conform to specifications. | "Dimensional inspections are routinely performed," and specifications "have been met." |
| Surface Characteristics | Surface treatment and properties should be comparable or superior to predicate devices. | TPS coating is present and analyzed, noted as being similar to predicate devices. "Abrasion testing to oneoro TF & Soung East and Restorative Alloys has been performed" (though the full context of this test related to surface characteristics is somewhat unclear, it implies an evaluation of surface interaction). |
2. Sample Size Used for the Test Set and the Data Provenance
This submission does not describe a clinical study with a traditional "test set" of patients or data. Instead, it relies on non-clinical bench testing to demonstrate substantial equivalence.
- Sample Size: Not applicable in the context of a patient-based test set. The reported tests (dimensional, bending strength, corrosion, abrasion, mechanical properties of coating) would have involved specific numbers of device samples or material specimens, but these quantities are not specified in the document.
- Data Provenance: The tests are explicitly described as "Nonclinical Tests" performed on the device itself. Therefore, the data originates from laboratory and bench testing. The country of origin is not explicitly stated for the testing facilities, but the submitter is Lifecore Biomedical, Inc. located in Chaska, Minnesota, USA. The data is retrospective in the sense that these tests were conducted on the manufactured device models to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no human "ground truth" establishment for this type of non-clinical, bench testing. The "ground truth" for these tests would be the established engineering and materials science principles and the specifications of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as there is no human "test set" or diagnostic assessment requiring adjudication. The assessment of test results would be against pre-defined engineering specifications and comparison to predicate device characteristics.
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 document pertains to a dental implant, a physical medical device, not a diagnostic AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The "ground truth" in this context is the established performance and characteristics of the legally marketed predicate devices, coupled with engineering specifications and scientific principles for material safety and mechanical integrity. The goal is to show the subject device is "substantially equivalent" to these established devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
§ 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.