(168 days)
The LOCATOR® RTx 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.
LOCATOR® RTx Attachment System is compatible with the following implant systems.
| Implant Manufacturer: | System: |
|---|---|
| BioHorizons | Internal Hex (3.0, 3.5, 4.5, 5.7 mm) |
| External Hex (3.5, 4.0, 5.0 mm) | |
| Biomet 3i | Certain Internal (3.4, 4.1, 5.0, 6.0 mm) |
| External Hex (3.4, 4.1, 5.0, 6.0 mm) | |
| Camlog | Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm) |
| iSy (3.8, 4.4, 5.0 mm) | |
| Dentsply | Ankylos (3.5, 4.5, 5.5, 7.0 mm) |
| XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm) | |
| Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) | |
| MIS Implants | Internal Hex (3.75, 4.5 mm) |
| Nobel Biocare | Replace: Internal (3.5, 4.3, 5.0, 6.0 mm), |
| NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm), | |
| Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) | |
| Straumann | Tissue Level (3.5, 4.8, 6.5 mm) |
| Bone Level (3.3, 4.1, 4.8 mm) | |
| Zimmer | Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm) |
| Spline (3.25, 4.0, 5.0 mm) | |
| Swiss Plus: Internal Octagon (3.8, 4.8 mm) |
LOCATOR® RTx 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 RTx 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 RTx is designed to accommodate a path of insertion on implants that are divergent up to 30° unless prohibited by the implant manufacturer. LOCATOR RTx abutments are provided with either TiCN or TiN coating and are available in six cuff heights (1, 2, 3, 4, 5, and 6 mm). They are provided in diameters 3.0 - 7.0 mm as shown in the compatibility table above.
This document describes the regulatory approval for a medical device called "LOCATOR® RTx". It is a Premarket Notification (510(k)) submission to the FDA. The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than proving performance against specific acceptance criteria for a novel device.
Therefore, the information typically requested in your prompt regarding acceptance criteria, performance data from a study, sample sizes, ground truth establishment, expert adjudication, and MRMC studies for AI/ML device performance is not directly applicable or available in this type of regulatory submission for a dental implant abutment system.
Here's a breakdown of why the requested information isn't present and what is provided:
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Acceptance Criteria and Reported Device Performance (Table 1): This document does not list quantitative acceptance criteria or corresponding performance scores for the device's clinical efficacy or accuracy in the way an AI/ML device would. Instead, it demonstrates equivalence through design, materials, intended use, and compatibility with existing implant systems. The "performance data" refers to non-clinical testing.
- What is provided: A comparison table (page 6) outlines design parameters (Abutment Diameter, Abutment Angle, Abutment/Implant Interface, Divergence Allowance, Prosthesis Attachment Type, Material) between the subject device (LOCATOR® RTx) and its primary and additional predicate devices. The "performance" is implicitly considered equivalent if these parameters are similar and non-clinical tests (sterilization, biocompatibility, coating characterization) pass.
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Sample sizes for test set and data provenance: Not applicable. This wasn't a clinical performance study with a test set of patient data. The "performance data" was non-clinical testing.
- What is provided: Mention of non-clinical testing: "sterilization testing, biocompatibility testing of the TiCN coating, and characterization testing of the TiCN coating." No sample sizes for these tests are explicitly stated in this summary.
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Number of experts and qualifications for ground truth: Not applicable. Ground truth typically refers to objective labels for a dataset used to evaluate diagnostic or prognostic performance (e.g., confirmed disease status for an AI model). This is not that type of study.
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Adjudication method for the test set: Not applicable.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device or a device where human interpretation of medical images is involved.
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Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.
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Type of ground truth used: Not applicable in the context of an AI/ML device. For this device, "ground truth" might be considered to be established engineering specifications and material standards that the device must meet during manufacturing and testing.
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Sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
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How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Acceptance (as presented in a 510(k) context):
The "acceptance criteria" for the LOCATOR® RTx are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through the following:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Feature/Parameter | Implied Acceptance Criteria (Equivalence to Predicates) | Reported Device Performance (LOCATOR® RTx) |
|---|---|---|
| Indications for Use | Must be substantially equivalent to predicates, showing suitability for overdentures or partial dentures retained by endosseous implants in the mandible or maxilla. | "The LOCATOR® RTx 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." This aligns with the primary predicate and is broadened slightly in the reference device but remains fundamentally equivalent in use. |
| Design: Abutment Diameter | Comparable range to predicates. | 3.0 to 7.0 mm (Wider range than primary predicate (3.25-6.5mm) but within/overlapping with ranges of multiple compatible implant systems listed). |
| Design: Abutment Angle | Straight (like predicates). | Straight |
| Design: Abutment/Implant Interface | Compatible with common implant interfaces used by predicates. | Conical, External Hex, Internal Hex, Internal Multi Lobe (Similar to primary predicate; reference device has "Internal Taper"). |
| Design: Divergence Allowance | Comparable to or improved upon predicates while still being safe and effective. | 30°/60° (except when prohibited by implant manufacturer) (Greater than primary predicate's 20°/40°, but similar to reference device's 33°/66°. This indicates a design improvement while staying within accepted medical practice for dental implants). |
| Design: Prosthesis Attachment Type | Similar attachment mechanism (e.g., retention cap). | Nylon or PEEK male retention cap (Primary predicate uses "Nylon male retention cap". The use of PEEK is noted as a similarity). While the reference device uses "Screw-retained", the subject device clearly aligns with the primary predicate's attachment method. |
| Material: Abutment | Biocompatible and strong material (e.g., Titanium alloy). | Ti-6Al-4V ELI (Identical to both predicates). |
| Material: Prosthetic Retention Component | Biocompatible polymer (e.g., Nylon). | Nylon or PEEK (Primary predicate uses "Nylon". The addition of PEEK is within acceptable material performance for this component). |
| Sterilization | Must meet validated sterilization standards. | Validated to ISO 17665-1 and ISO 17665-2. (Demonstrated by "sterilization testing"). |
| Biocompatibility | Must be biocompatible (non-toxic, non-irritating, non-sensitizing). | Tested to ISO 10993-1, ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Skin Sensitization). Results indicated biocompatibility. (Demonstrated by "biocompatibility testing of the TiCN coating"). |
| Coating Characterization | The TiCN coating must be characterized to ensure its safety and performance. | "characterization testing of the TiCN coating" was performed. |
2. Sample Sized used for the test set and the data provenance:
* As explained, this was a 510(k) for substantial equivalence based on design, materials, and non-clinical performance testing (sterilization, biocompatibility, coating characterization). There isn't a "test set" in the context of clinical data for performance evaluation. Data provenance would be from internal lab testing for the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth in this context is based on established engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The "ground truth" for demonstrating substantial equivalence and safety/effectiveness in a 510(k) for this type of device relies on:
* Compliance with recognized standards: ISO 17665 (sterilization) and ISO 10993 (biocompatibility).
* Comparison to predicate devices: The established safety and effectiveness of the primary and reference predicate devices serve as the benchmark.
* Engineering and materials specifications: Ensuring the device meets its design specifications and material properties.
8. The sample size for the training set:
* Not applicable. No "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
* Not applicable.
§ 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.)