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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.

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.

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