(87 days)
MIS Dental Implant System 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS LYNX short implants are indicated for delayed loading only.
The two additional implant size offerings which are being added to the predicate MIS LYNX Conical Connection Dental Implant System (K241692), and are the subject of this submission, consist of a standard platform, 4.20 mm diameter implant and a wide platform, 5.00 mm diameter implant, each available in a 6 mm length.
The proposed implant offerings, as their predicate K241692, are root-form, bone-level, self-tapping, two-piece, screw-type implants which are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function.
Each implant offering is provided with a compatible cover screw based on the implant platform (standard and wide). The cover screws are identical to those cleared in K241692 and are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. The cover screw is screwed into the implant's internal thread and the gums are sutured over the cover screw. The cover screw's purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and is then removed and replaced by either a healing cap or an abutment.
The implants and cover screws are manufactured from titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).
The proposed implants feature an outer profile which has a coronal section which is cylindrical and an apical section which is conical. The outer threads are designed so the implant has a self-drilling property. The implant's geometric design includes a dual thread feature and spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants feature a round (cylindrical) neck.
The proposed MIS LYNX Conical Connection Implants have a conical connection with an anti-rotation index of six positions and an internal thread for cover screws, screw-retained abutments and screwed healing caps. The implant-abutment connection surface of the proposed implants is anodized for color coding purposes to indicate the platform: purple for standard platform implants, and green for wide platform implants. The cover screws are also anodized for platform color coding.
The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in patients.
This 510(k) clearance letter pertains to an Endosseous Dental Implant System, which is a physical medical device, not a software-driven AI device. Therefore, the concepts of acceptance criteria, study data, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for AI models, and training set sizes are not applicable to the information provided.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the context of an AI-driven system. The "acceptance criteria" here are implicitly the standards and performance levels demonstrated by the predicate and reference devices, as well as relevant ISO and ASTM standards.
Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the device type:
Device: MIS LYNX Conical Connection Implant System
This device is an endosseous dental implant system, a physical medical device. The FDA clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on the performance of an AI algorithm. Therefore, many of the requested fields related to AI model evaluation are not applicable.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally understood to be compliance with relevant international and national standards for dental implants, and performance comparable to or exceeding established predicate/reference devices.
Table of Acceptance Criteria (Inferred from testing) and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reference Standard / Basis | Reported Device Performance |
|---|---|---|
| Mechanical Fatigue Strength | ISO 14801:2016, FDA Guidance | "confirms that the proposed device is similar in or exceeds performance when compared to the predicate (K241692) and reference (K180282) devices." |
| Bone-to-Implant Strength (Pull-out) | ASTM F543-23 Annex 3 | "the proposed device exhibited average pull-out forces which were larger than those of the reference device (K180282)." |
| MR Safety (Magnetically induced displacement force) | ASTM F2052-21 | Leveraged from predicate (K241692), device is labeled MR Conditional. |
| MR Safety (Magnetically induced torque) | ASTM F2213-17 | Leveraged from predicate (K241692), device is labeled MR Conditional. |
| MR Safety (Image Artifact) | ASTM F2119-07 (2013) | Leveraged from predicate (K241692), device is labeled MR Conditional. |
| MR Safety (RF Induced Heating Simulation) | Computational modeling and simulation (CM&S) | Leveraged from predicate (K241692), device is labeled MR Conditional. |
| Surface Area (Bone Contact) | CAD Software Analysis | "the implant surface area and initial bone-to-implant contact area calculations, simulating the recommended surgical drilling protocol in a CAD model, is equivalent between proposed and reference (K180282) implants of the same length and diameter." |
| Biocompatibility | N/A - Leveraged from predicate | "additional biocompatibility... testing was not necessary to demonstrate substantial equivalence of the proposed device" due to identical materials and manufacturing processes. |
| Sterilization | N/A - Leveraged from predicate | "additional... sterilization... testing was not necessary" due to identical processes. |
| Package and Shelf life | N/A - Leveraged from predicate | "additional... package and shelf life testing was not necessary" due to identical materials and processes. |
Regarding the other requested information (primarily relevant to AI/Software-as-a-Medical-Device):
-
Sample size used for the test set and the data provenance: Not applicable. The testing done was laboratory-based mechanical and MR safety testing, not evaluation of an AI model with a clinical test set. The implant dimensions analyzed for surface area were "smallest implant length (6 mm) and diameter (4.20 mm)" for proposed and reference devices. Pull-out testing and fatigue testing would have involved a number of physical samples per test, but specific quantities are not detailed in this summary.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI (e.g., expert labels on medical images) is not relevant here. The "ground truth" for mechanical testing is established by physical measurements and engineering principles.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
-
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 a physical dental implant, not an AI assistance system for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical properties, the "ground truth" is derived from established engineering test methods and their performance metrics (e.g., load at failure, cycles to failure). For MR safety, it's compliance with established safety limits for magnetic fields.
-
The sample size for the training set: Not applicable. There is no AI model or training set mentioned.
-
How the ground truth for the training set was established: Not applicable.
In summary: The provided document is an FDA 510(k) clearance letter for a conventional physical medical device (dental implant system). The evaluation and clearance process for such devices involve demonstrating safety and effectiveness by showing substantial equivalence to existing legally marketed devices, typically through non-clinical (laboratory) testing, materials characterization, and compliance with recognized standards. The concepts and terminology in your request are largely tailored to the evaluation of AI/Machine Learning-driven medical devices, which is not what this document addresses.
N/A