(213 days)
The Icon Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas:
- Support of fixed (cemented) restorations utilizing multiple abutments;
- Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments;
- Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar;
- Terminal or intermediate abutment support for fixed bridgework;
- Free standing restorations without involvement of adjacent dentition when the external hex is engaged.
The Bio Science Technologies, Inc.'s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc.
The Bio Science Technologies, Inc.'s Icon Implant System gained 510(k) clearance by demonstrating substantial equivalence to the legally marketed predicate device, the Branemark System® Mk II Self-Tapping Fixture (K945398). The submission relies on a comparison of characteristics rather than a study with acceptance criteria and measured performance.
Here's an analysis of the provided information, addressing your points:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, there aren't explicit "acceptance criteria" in terms of performance metrics with thresholds, nor is there "reported device performance" in the traditional sense of a study measuring clinical outcomes. Instead, the "acceptance criterion" is a demonstration of substantial equivalence to a predicate device.
| Characteristic/Comparison Point | Predicate Device (Branemark System® Mk II Self-Tapping Fixture) | Icon Implant System (reported "performance" relative to predicate) |
|---|---|---|
| Intended Use | To be surgically placed in the bone of the upper and the lower jaw arches to provide support for prosthetic devices such as artificial teeth and to restore the patient's chewing function. | Identical to predicate: Support of fixed (cemented) restorations, fixed detachable (screw retained) prosthetics, overdenture retention, terminal/intermediate abutment support for fixed bridgework, free-standing restorations. |
| Material | Commercially-pure titanium grade 1 | Commercially-pure titanium grade 3 or 4 |
| Diameters (mm) | 3.75 | 3.3, 3.75, 4.0 |
| Lengths (mm) | 10, 13, 15, 18 | 7, 8, 10, 13, 15, 18 |
| Design (Polished Collar) | Present | Present |
| Design (Self-Tapping) | Present | Present |
| Design (External Hex) | Present | Present |
| Design (Passivated) | Present | Present |
| Basic Features | Endosseous implant, osseointegration | Endosseous implant, osseointegration (identical) |
| Surgical Protocols | Similar | Similar |
| Healing Period Routine | Same | Same |
Conclusion on Equivalence: The submission asserts substantial equivalence based on the similarities in intended use, design principles, material (both commercially-pure titanium), and similar surgical/healing protocols. Differences in grades of titanium (grade 1 vs. 3 or 4) and ranges of diameters/lengths were presented as minor differences that do not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There was no test set as described for performance evaluation. This submission is a comparison to a predicate device. The data provenance is a description of the proposed device and a comparison to the predicate device's specifications.
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. No ground truth was established by experts for a test set in this context. The "ground truth" for the comparison was the specifications and intended use of the predicate device, which was already cleared by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used requiring adjudication.
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 a medical device (dental implant), not a diagnostic AI system, and no MRMC study was conducted.
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 this 510(k) submission is the pre-existing FDA clearance of the predicate device, Branemark System® Mk II Self-Tapping Fixture (K945398), and its established specifications and clinical performance, against which the new device is compared for substantial equivalence.
8. The sample size for the training set
Not applicable. No "training set" was used as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. The concept of a "training set" and its ground truth establishment is not relevant to this type of device clearance.
§ 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.