(57 days)
Indications for use of the 3i Endosseous Dental Implant Systems are not altered by this submission. An Endosseous Dental Implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function.
The proposed "Rocket II" implant design consists of the current 31 designs for a commercially pure titanium, screw-type implant (3i Standard Threaded, Self-Tapping or titanium alloy cylindrical implant, plasma sprayed with Commercially Pure Titanium, modified to include the extended, internally tapered coronal aspect, very similar to the ITI Straumann Dental Implant System. This will be a modified 3i design and will be offered as an option to current 31 implant and restorative systems. All aspects of the proposed design modification are related to the coronal aspect of the implants. No other unplant design feature, material or processing aspect is being altered.
"Rocket II" modified threaded implants will be available in Standard Threaded or Self-Tapping ("ICE" Incremental Cutting Edge) designs with either machined or "OsseoTite" (acid etched) surfaces, in identical sizes as currently available: Diameters between 3.25 and 6.00 mm's and lengths between 7 0 and 20.0mm's. The polished, extended coronal aspect of the implant is of various lengths between 1.0 and 4.0 mm's to provide the clinician a variety of transmucosal options
The "Rocket II" design modification provides an implant that permits single surgical stage placement with coronal aspect of cover screw at or just below the mucosal tissue surface.
The internal aspect of the transmucosal aspect of the implant consists of a modified "Morse" taper with an interlocking "Hex" feature for two-piece abutment components. With the exception of the interlocking hex feature, the coronal aspect of the "Rocket II" design is very similar to what Straumann markets as its "Morse Taper".
The provided text is a 510(k) premarket notification for a dental implant system design modification. It primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested information points (acceptance criteria, study details, sample size, ground truth, expert qualifications, etc.) are not available in the provided document. The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of design, materials, and intended use, rather than extensive direct clinical performance studies for minor design modifications.
Here's what can be extracted and what is explicitly not available from the text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not Available - No specific quantitative acceptance criteria or performance metrics are defined in the document. | Not Available - No reported device performance data is presented. | The submission focuses on design modification and substantial equivalence to predicate devices, not on proving performance against specific criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The document does not describe a test set or any performance study data that would have a sample size or provenance information.
3. 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/Not Available. Since no performance study is described for this specific design modification, there is no mention of experts establishing a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Available. No test set or adjudication method is described.
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 device is a physical dental implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As a physical dental implant, there is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Available. Without a performance study, the concept of "ground truth" as typically applied to diagnostic or prognostic devices does not apply here. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices, which relies on design comparison and established clinical history of the predicate devices.
8. The sample size for the training set:
- Not Applicable/Not Available. This document does not describe a training set for any machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable/Not Available. Not relevant to this type of device and submission.
Summary of what the document DOES state regarding equivalence and justification:
- Reason for Submission: Design modification ("Rocket II" feature) to existing 3i implant systems.
- Key Modification: Incorporates an internally tapered coronal aspect, similar to the ITI Straumann Dental Implant System, to allow for a one-stage surgical procedure and potentially reduce abutment loosening.
- Primary Argument for Equivalence: The "Rocket II" design combines features already found in two legally marketed predicate devices:
- 3i's current threaded (Standard Threaded, Self-Tapping, "OsseoTite" surface) and Titanium Plasma Sprayed (TPS) Cylindrical implant body designs.
- The internally tapered, single surgical stage superior aspect of the ITI Straumann Dental Implant System.
- Material Changes: "No new materials, processes, devices or indications for use or performance claims are being made at this time."
- Sterilization: Will be packaged and distributed presterilized to a Sterility Assurance Level of 10-6, with validation per AAMI and international standards.
- Indications for Use: "Indications for use of the 3i Endosseous Dental Implant Systems are not altered by this submission."
- Basis for "Predictable Outcomes": The document mentions that existing 3i systems "provide excellent clinical benefit with very predictable outcomes" and relies on this established history for the predicate devices. It also states that micro-movement (which the new design aims to reduce) is "well documented in the literature" as a cause of screw loosening. This vaguely points to prior clinical understanding rather than new study data for this submission.
In essence, this 510(k) submission leverages the known safety and effectiveness of its own prior designs and a competitor's design to demonstrate substantial equivalence for a design modification, without conducting new clinical performance studies to define and meet specific acceptance criteria.
§ 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.