(75 days)
Nobel Biocare's Groovy Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Groovy lmplants are indicated for single or multiple unit restorations in splinted applications. Nobel Biocare Groovy Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
Groovy implants are indicated for use in soft bone in posterior regions or whenever immediate or early loading is applied. The Groovy implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to nongrooved implants.
Nobel Biocare Groovy Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.
Nobel Biocare Groovy Implants incorporate a groove on the implant thread and are machined from titanium. Groovy Implants are available straight or tapered, and have a surface treatment consisting of a thin, uniform titanium oxide layer (Tillnite"). Groovy Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion where good initial stability of the implant can be obtained.
The design of the Nobel Biocare Groovy Implant incorporates a groove on the implant thread. Bone is formed more rapidly within the groove compared with other parts of the implant, resulting in faster integration of the implant. The bone formation within the groove results in a mechanical interlock, which gives the implant increased stability compared with implants without the groove. These properties will be of special importance when placing implants in soft bone in posterior regions or whenever immediate or early loading is applied.
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided text does not contain any explicit acceptance criteria or a study detailing the device’s performance against such criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics for a novel technology or a clinical study showing numerical results.
However, based on the device description and indications for use, we can infer some implied "performance" claims relative to a predicate device without the "groove" feature.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied Claims) |
|---|---|
| Ability to provide support for prosthetic devices to restore esthetics and chewing function. | The device is a root-form endosseous implant intended for this purpose. (Identical to predicate) |
| Suitable for single or multiple unit restorations in splinted applications. | The device is indicated for this purpose. (Identical to predicate) |
| Capability for immediate placement and immediate function (given initial stability). | The device "may be placed immediately and put into immediate function providing that the initial stability requirements... are satisfied." (Identical to predicate) |
| Improved stability/faster integration in soft bone/immediate/early loading. | "Bone is formed more rapidly within the groove compared with other parts of the implant, resulting in faster integration of the implant." |
| "The bone formation within the groove results in a mechanical interlock, which gives the implant increased stability compared with implants without the groove." | |
| These properties "will be of special importance when placing implants in soft bone in posterior regions or whenever immediate or early loading is applied." | |
| Groovy implants are "preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any specific test set, sample size, or data provenance because no performance study, in the sense of clinical trials or specific product testing, is described. The 510(k) summary relies on demonstrating substantial equivalence to a predicate device via design and intended use, rather than new performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the absence of a described test set or performance study, there is no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
As no test set or study is described, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was mentioned or implied in the provided 510(k) summary. This type of study is typically associated with AI-driven diagnostic tools, not dental implants.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is irrelevant to the device described. The Groovy Implants are physical medical devices, not AI algorithms. Therefore, no standalone algorithm performance was done.
7. The Type of Ground Truth Used
Since no performance study with a test set is described, no specific "ground truth" was established or used in the context of device performance data analysis. The "ground truth" for a 510(k) submission primarily relates to regulatory compliance and substantial equivalence to a predicate device, as confirmed by regulatory review. The claims made in the document about faster bone formation and increased stability appear to be based on the design rationale and presumably, scientific understanding of bone-implant interaction, though no specific study proving these claims is presented.
8. The Sample Size for the Training Set
This question is irrelevant as the device is not an AI algorithm and therefore has no training set.
9. How the Ground Truth for the Training Set Was Established
This question is irrelevant as the device is not an AI algorithm and therefore has no training set.
§ 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.