(156 days)
The LOCATOR R-Tx® Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The LOCATOR R-Tx Attachment System is compatible with the following implant systems: (list of compatible implant systems and diameters follows).
LOCATOR R-Tx implant attachment system, consists of abutments, nylon or PEEK liners and denture caps to serve in a similar function to LOCATOR as a resilient attachment for endosseous implants. All LOCATOR R-Tx abutments are made of titanium alloy and have the same coronal double ridge retention design that attaches to the overdenture component. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. LOCATOR R-Tx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR R-Tx abutments are provided with either TiCN or TiN coating and available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). The abutments are provided in diameters 3.0 - 6.5 mm as shown below in the compatibility table.
This document describes the regulatory submission for the LOCATOR R-Tx® Attachment System and its substantial equivalence to a predicate device (K150295). It's important to note that this is a dental implant attachment system, not an AI/ML powered medical device. Therefore, the questions regarding AI/ML specific acceptance criteria, test sets, ground truth, and human reader studies are not applicable to this document.
The "study that proves the device meets acceptance criteria" in this context refers to the engineering analysis and demonstration of compatibility, rather than clinical trials or AI/ML performance metrics.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance (for a physical dental device):
The acceptance criteria for the LOCATOR R-Tx® Attachment System revolve around its compatibility with various implant systems and ensuring that its performance is equivalent to the predicate device (K150295) without introducing new risks.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (How the device meets the criteria) |
|---|---|---|
| Compatibility | Compatibility with specified dental implant systems regarding dimensions, interface, and function. | Verified through: |
- OEM signed abutment drawings
- OEM implant drawings
- Established compatibility with LOCATOR abutments through mutual contractual agreements with OEM.
- Engineering analysis and documentation for Line Extensions. |
| Material | Abutment material: Ti-6Al-4V ELI. Prosthetic Retention Component: Nylon or PEEK. | Matches predicate device: Abutment is Ti-6Al-4V ELI, Prosthetic Retention Component is Nylon or PEEK. |
| Design Features | Female Abutment, Nylon Male, Denture Cap. Allows for 30° divergence. Abutment diameter range 2.75 - 6.0 mm. | Matches predicate device: Female Abutment, Nylon Male, Denture Cap. Allows 30° divergence. Abutment diameter range specified (note: subject device range (2.75-6.0mm) falls within predicate range (3.0-7.0mm)). |
| Mode of Operation | Functions as an abutment connecting to a housing embedded in a denture ridge, using nylon inserts for denture connection/disconnection. | Matches predicate device's mode of operation. |
| Risk Profile | No new or increased risks compared to predicate. Remains tissue-supported. | Engineering analysis confirmed no new worst-case scenarios, no new risks, and no impact on the risk profile of the predicate device (K150295). |
| Biocompatibility | Biocompatibility remains applicable. | Compatibility confirms all testing (including biocompatibility) from predicate K150295 remains applicable. |
| Sterilization | Sterilization remains applicable. | Compatibility confirms all testing (including sterilization) from predicate K150295 remains applicable. |
| Surface Characterization | Surface characterization remains applicable. | Compatibility confirms all testing (including surface characterization) from predicate K150295 remains applicable. |
| Manufacturability, Cleaning/Disinfection, Packaging, Shipping | Identical to predicate device. | Stated as identical to the predicate device. |
Regarding the AI/ML specific questions:
- Sample size used for the test set and the data provenance: Not applicable - this is a physical dental device, not an AI/ML device. The "test set" here refers to the parameters and specifications of various dental implants.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable - ground truth is established by manufacturers' specifications and engineering standards for mechanical compatibility.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Ground truth is based on engineering specifications and direct compatibility checks.
- 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 device, not an AI/ML device assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable - no algorithm involved.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device is based on engineering specifications, dimensional compatibility, and established industry standards for dental implant systems. This includes signed drawings from Original Equipment Manufacturers (OEMs) and contractual agreements related to compatibility.
- The sample size for the training set: Not applicable - no AI/ML training set.
- How the ground truth for the training set was established: Not applicable - no AI/ML training set.
Summary for this specific device:
The "study" proving the device meets acceptance criteria is primarily an engineering analysis and verification of the physical compatibility of the LOCATOR R-Tx® Abutment with various dental implant systems. This involves comparing the design and dimensions of the subject device's abutment-implant interface against the specifications of the vast array of listed implant systems (OEM data, drawings, and established compatibility). The core argument for substantial equivalence is that the modifications are minor and do not introduce new risks or alter the fundamental performance demonstrated by the predicate device (K150295).
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)