(201 days)
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.
This 510(k) requests an expansion of the indications for use of all externally and internally hexed 3i dental implants to include immediate loading procedures in the mandible when using a minimum of four (4) splinted implants ≥ 10mm in length. Standard, commercially available 3i abutments and screws can be used with 3i dental implants in immediate loading procedures. Several new components will complement the standard line for the clinicians use as necessary in immediate occlusal loading.
The provided 510(k) summary for K030614 describes the acceptance criteria and supporting studies for the 3i Dental Implants, specifically for the expansion of indications to include immediate loading procedures in the mandible.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in a clear, tabulated format for the clinical performance. Instead, it relies on substantiating "clinical success" and "osseointegration" based on existing literature and previous clearances.
| Acceptance Criteria (Inferred from submission) | Reported Device Performance (Summary of Clinical Studies) |
|---|---|
| Mechanical Performance: | |
| Static Load Compression Testing | Passed (to simulate biting forces) |
| Cyclic Fatigue Testing | Passed (to simulate chewing forces) |
| Insertion Torque (for new single piece abutment) | Passed (at more than five times the recommended 20 Ncm) |
| Cyclic Fatigue (for new single piece abutment) | Passed |
| Clinical Performance (Immediate Loading): | |
| Maintenance of Osseointegration | Tarnow et al: 104 out of 107 implants osseointegrated (for various implants, including 3i and others). Implants failed due to infection or provisional restoration issues, not immediate loading itself. |
| Testori et al: Clinical and histologic osseointegration confirmed for immediately loaded implants (78%-85% bone-to-implant contact after 4 months). | |
| Ibanez and Jalbout: 100% success after 2-3 years follow-up for 87 Osseotite implants in immediate loading. | |
| Absence of Implant Mobility | Ibanez and Jalbout: No implant mobility found. |
| Absence of Periimplant Radiolucency | Ibanez and Jalbout: No periimplant radiolucency found. |
| Low Implant Loss Rate | Defrancq et al: 2 out of 417 Osseotite implants lost in 68 mandibular procedures (0.48% loss). 9 out of 309 Osseotite implants lost in 34 maxilla procedures (2.9% loss). |
| Overall "Clinical Success" | Tarnow et al, Testori et al, Defrancq et al, Ibanez and Jalbout all report successful use or clinical success. |
2. Sample Size Used for the Test Set and the Data Provenance
The submission primarily relies on a literature review of previously published clinical studies, rather than a single, dedicated prospective clinical trial for this specific 510(k) submission. Therefore, "test set" sample sizes are derived from these referenced studies.
- Tarnow et al.: 107 implants (in 10 edentulous cases).
- Testori et al.: 12 Osseotite implants (in 1 patient).
- Defrancq et al.: 417 Osseotite implants in 68 mandibular procedures; 309 Osseotite implants in 34 maxilla procedures.
- Ibanez and Jalbout: 87 Osseotite implants in 11 patients.
- Data Provenance: The studies are published clinical literature. The country of origin is not explicitly stated for all, but given the names and journals, they are likely international, possibly with an emphasis on European and North American research. All are retrospective analyses of cases or small prospective case reports/series.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. The summarized studies are clinical publications, and the ground truth (e.g., osseointegration, implant success/failure) would have been established by the clinicians/researchers involved in those individual studies based on standard dental and surgical assessment methods (clinical examination, radiographs, and for one study, histologic analysis). There is no mention of an independent panel of experts establishing a ground truth for a unified "test set" for this 510(k) specifically.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable in the context of this submission. Since the submission relies on published literature, there's no mention of a formal adjudication method for a specific test set. The outcomes in the referenced studies were assessed by the respective study authors.
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 submission is for dental implants, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness is presented.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (dental implant), not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the referenced clinical studies was primarily:
- Outcomes Data: Clinical success/failure, implant survival rates, absence of mobility, absence of periimplant radiolucency.
- Clinical Examination: Assessment of implant stability and health.
- Radiographic Examination: To check for periimplant radiolucency and bone levels.
- Histology/Pathology: Testori et al. specifically mention "histologic analysis after 4 months of occlusal loading" and "histomorphometric evaluation revealed 78%-85% bone-to-implant contact."
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a medical device, not a machine learning algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The submission leverages a combination of non-clinical (mechanical) testing and a literature review of clinical studies to demonstrate that the 3i Dental Implants, when used for immediate loading, are "substantially equivalent" to predicate devices and clinically successful.
Non-clinical Testing:
- Mechanical tests (Static Load Compression, Cyclic Fatigue) were performed on 3i implants and the new single-piece abutment. These tests simulated biting and chewing forces and passed established criteria, showing the components' physical integrity. Insertion torque for the new abutment also passed, exceeding recommended levels.
Clinical Performance (Literature Review):
The submission relies on a review of existing clinical literature, specifically highlighting four studies:
- Tarnow et al. (1997): A case series involving various implant types (including 3i) for immediate loading in edentulous arches, reporting high osseointegration rates.
- Testori et al. (2001): A case report on Osseotite implants in the mandible, demonstrating clinical and histologic osseointegration during immediate loading, with good bone-to-implant contact.
- Defrancq et al. (2002): A report on successful immediate loading techniques using Osseotite implants in both maxilla and mandible, with very low implant loss rates (e.g., 0.48% in mandibular procedures).
- Ibanez, JC, Jalbout,ZN (2002): A two-year follow-up study on Osseotite implants for immediate loading, reporting 100% success with no implant mobility or periimplant radiolucency.
The submission argues that these studies, along with prior animal studies (K983347) and general current clinical practice, provide sufficient evidence of "substantial clinical success with early loading" for implants similar in design and materials to the 3i implants, thereby supporting the expanded indication for immediate loading. The overall argument for acceptance is based on the substantial equivalence of the 3i implants to other legally marketed devices indicated for immediate loading, supported by safety and performance data from both non-clinical testing and clinical literature review.
§ 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.