(258 days)
The U fit Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The U fit Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
The U fit Implant System is a dental implant system made of Titanium-6A1-4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for lading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with RBM (Resorbable Blasted Media). The Fixture diameters are 3.8, 3.9, 4.0, 4.1, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm and lengths are 7. 8.5, 10. 11.5, 13, 14.5 mm in this system. The contained various abutments and accessories in the system are cover screw, abutment screw, healing abutment, solid abutment, transfer abutment, milling abutment, Temporary Abutment, protect cap, solid impression coping, solid lab analog, impression coping/pick-up, impression coping/transfer, and fixture lab analog. The material of abutments and accessories are Ti-6A1-4V ELI(ASTM F-136), POM-C and stainless steel. The abutment diameters are 4.0, 4.1, 4.4, 4.5, 4.8, 5.0, 5.5, 5.8, 6.0, 6.3, 6.5, 6.8, 7.0, 7.3, 7.8 and Heights are 4.0, 5.5, 7.0, 9.0. The implants are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.
The provided text is a 510(k) summary for the U fit Dental Implant System. It describes the device, its intended use, and compares it to predicate devices. However, it does not include information about specific acceptance criteria or a "study that proves the device meets the acceptance criteria" in the format typically associated with clinical performance evaluations for AI/ML devices.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of materials, intended use, and non-clinical performance testing. The "acceptance criteria" here implicitly refer to meeting the standards outlined in the FDA's guidance for root-form endosseous dental implants and abutments, and satisfying general safety and effectiveness requirements by demonstrating similarity to legally marketed devices.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence.
| Aspect of Acceptance/Comparison | Predicate Device (OSSETEM US/SS/GS System & Dentium IMPLANTIUM ABUTMENTS) Performance | Subject Device (U fit Dental Implant System) Performance | Comparison Outcome |
|---|---|---|---|
| Intended Use | Indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. For single and two stage surgical procedures. Intended for delayed loading. | Identical. | Substantially Equivalent |
| Material (Fixture) | Ti-6Al-4V ELI ASTM F136 | Ti-6Al-4V ELI ASTM F136 | Substantially Equivalent |
| Material (Abutments/Accessories) | Ti-6Al-4V ELI Gr.23, CP Ti Gr.4, ASTM F136, POM-C | Ti-6Al-4V ELI Gr.23, CP Ti Gr.4, ASTM F136, POM-C, Stainless Steel | Substantially Equivalent (Minor variations in specific grades, but still generally equivalent materials) |
| Fixture Type | Submerged | Submerged | Substantially Equivalent |
| Surface Treatment | RBM | RBM | Substantially Equivalent |
| Biocompatibility | Complies with ISO 10993 series, ASTM F67, F750-87, USP, , ISO 7405 | Complies with ISO 10993 series (3, 5, 6, 10, 11), ASTM F67, F750-87, USP, , ISO 7405 | Substantially Equivalent |
| Sterilization Validation | Complies with ISO 11737-1 & -2 (Gamma), ISO 17665-1 & -2 (Steam) | Complies with ISO 11737-1 & -2 (Gamma), ISO 17665-1 & -2 (Steam). Note: Subject device implants are supplied sterile (gamma), abutments and accessories non-sterile (user steam sterilize). Predicate US/SS/GS Fixture Gamma sterilized; some predicate abutments Gamma, some user Steam. | Substantially Equivalent (Sterilization methods are validated and acceptable) |
| Chemical & SEM Analysis (RBM) | No residual post-RBM treatment. | No residual post-RBM treatment. | Substantially Equivalent |
| Compliance with Guidance | Designed, manufactured, and tested in compliance with "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | Designed, manufactured, and tested in compliance with "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | Substantially Equivalent |
| Differences | Slight differences in fixture designs and diameters compared to the predicate | Noted slight differences in fixture designs and diameters | Demonstrated to be safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable as the submission describes a medical device (dental implant system) made of physical materials, not an AI/ML software device that would use a "test set" of data in the common sense. The "testing" referred to is biocompatibility, sterilization validation, and material property testing, which are typically performed on samples of the manufactured device components rather than a "data set."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable. The assessment for this type of device does not involve expert readers establishing ground truth from images or data. Ground truth is established through laboratory testing following recognized standards.
4. Adjudication Method:
This information is not applicable. There is no adjudication method described as there are no expert interpretations to reconcile.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. MRMC studies are used for evaluating diagnostic software where human readers' performance is assessed with and without AI assistance. This device is a physical implant, not a diagnostic software.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable. This is not an algorithm or software device.
7. Type of Ground Truth Used:
The "ground truth" for verifying the safety and effectiveness of a dental implant system of this type is established through:
- Material Specifications: Adherence to ASTM standards (e.g., ASTM F136 for Ti-6Al-4V ELI).
- Biocompatibility Testing: Results from in vitro and in vivo tests (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility) according to ISO 10993.
- Sterilization Validation: Demonstrated sterility assurance level (SAL) according to ISO 11737 and ISO 17665.
- Surface Characterization: Chemical analysis and SEM imaging to confirm the RBM treatment and lack of residuals.
- Mechanical Testing (Implied): Although not explicitly detailed in the summary, dental implants typically undergo mechanical strength and fatigue testing to ensure they can withstand physiological loads. This is usually part of meeting the FDA's "Class II Special Controls Guidance Document."
8. Sample Size for the Training Set:
This information is not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable.
§ 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.