(175 days)
The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants.
Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants.
The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Laser-Lok™ surface treatment for dental implants:
The provided 510(k) summary focuses on establishing substantial equivalence for a line extension (a surface modification) to an already cleared device. As such, the testing and claims are primarily directed at demonstrating that the new surface treatment does not negatively impact the safety and effectiveness of the base implant, and that it maintains or improves certain characteristics.
The summary does not explicitly define specific numerical acceptance criteria in the way a typical diagnostic AI/ML device might (e.g., minimum sensitivity or specificity thresholds). Instead, the acceptance is based on demonstrating mechanical equivalence and beneficial biological responses, primarily through existing literature and animal/clinical testing which is summarized qualitatively.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Sufficient mechanical static and dynamic strength (in accordance with FDA guidance "Information for premarket notification submissions for screw-type endosseous implants" issued on December 9, 1996). | Results from an independent lab confirm the surface treatment has sufficient mechanical static and dynamic strength. |
| Safety - Inflammation | Does not reduce the safety and inflammation performance of Silhouette Implants. | "The Laser-Lok surface treatment on the collar does not reduce the safety and inflammation performance of Silhouette Implants." (No specific study details or metrics provided here, but likely inferred from animal/clinical testing referenced below). |
| Biological Width / Tissue Attachment | Engineer the biological width and tissue attachment to the collar. | Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth. |
| Bone Retention | Attach and retain bone adjacent to the implant. | The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant. |
2. Sample size used for the test set and the data provenance
- Mechanical Testing: Not explicitly stated. The document refers to "Results from an independent lab" but does not give sample sizes for these tests. Data provenance is implied to be from a testing laboratory.
- Animal Studies: Not explicitly stated, but referenced generally as "animal...testing." One literature reference (Ricci et al.) relates to a chapter in "Bone Engineering," and the other (Weiner et al.) is a presentation from a 2003 meeting and pending publication. These are likely retrospective (i.e., refers to previously published or presented work).
- Clinical Testing: Not explicitly stated. The document mentions "clinical testing" but provides no details on patient numbers, demographics, or study design. Likely retrospective (referring to existing data/literature).
- Finite Element Analysis (FEA): Not applicable for sample size as it is a computational method.
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 in the summary. For a device like this, ground truth would typically be established by objective measurements (e.g., mechanical testing, histological analysis in animal studies, clinical outcomes observed by dental professionals). The summary does not detail the specific methods for ground truth establishment or expert involvement for the test set specifically. The cited literature involves various researchers (Ricci, Charvet, Frenkel, Chang, Nadkarni, Turner, Alexander; Weiner, Simon, Ehrenberg, Zweig, Ricci), who would be considered experts in their respective fields (e.g., biological engineering, oral and maxillofacial implants).
4. Adjudication method for the test set
This information is not provided and is generally not applicable to the types of studies referenced (mechanical, animal, clinical observations/literature review rather than human-read image interpretation).
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers interpret images or data. The Laser-Lok surface treatment is a physical modification to an implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone AI algorithm performance study was not done. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Based on the references and nature of the device, the ground truth types would likely include:
- Mechanical measurements: For static and dynamic strength.
- Histological analysis / Biological data: For soft tissue attachment, epithelial down-growth, and bone response (likely from animal studies, pathology).
- Clinical observations / Outcomes data: For in-vivo performance regarding tissue integration and overall implant success (implied from "clinical testing").
- Literature/Expert consensus: The cited references support the claims, implying that the ground truth is established through accepted scientific and clinical findings.
8. The sample size for the training set
This information is not provided and is not applicable as this device does not involve an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this device does not involve an AI/ML algorithm that requires a "training set."
Summary of Limitations in the Provided Text for This Request:
The provided 510(k) summary is typical for a medical device modification rather than an AI/ML diagnostic tool. Therefore, many of the requested elements (like explicit numerical acceptance criteria, specific sample sizes for particular studies, details on expert ground truth establishment and adjudication, or AI-specific studies) are either not present or not fully detailed. The focus is on demonstrating substantial equivalence through a combination of mechanical testing, finite element analysis, and referencing animal and clinical studies, often drawing on existing literature and prior clearances.
§ 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.