(58 days)
The Leone Monoimplants for O-ring overdenture are indicated as therapy for the stabilization of removable prosthesis on lower arch. The Leone Monoimplants for O-ring overdenture are designed to be surgically inserted in the bone structure of the mouth, exclusively in the mandible at the level of the area between the two foramina, as an anchorage system for total removable prosthesis. To properly support a removable prosthesis, four monoimplants have to be inserted.
The Leone Monoimplant for O-ring overdenture is a one-piece endosseous dental implant where an endosseous portion and an abutment portion are defined. The implant is composed of titanium alloy for surgical use. The endosseous portion is a self-tapping screw with a sandblasted surface, while the abutment portion is made of a smooth tapered neck favouring soft tissues healing and mucosal seal and a ball shape top for the connection to the overdenture's microhousing. The monoimplant is supplied in different sizes and is intended for use in the overdenture O-ring therapy in the treatment of the total lower edentulism.
The provided text describes a medical device, the "Leone Monoimplant for O-ring overdenture," and its 510(k) summary for FDA clearance. This document is a premarket notification to establish substantial equivalence to predicate devices, not a study reporting on the device's performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this type of regulatory submission.
The document focuses on demonstrating that the new device is as safe and effective as legally marketed predicate devices, primarily through comparison of intended use, materials, design, and functional performance. It does not contain a detailed report of a study designed to evaluate the Leone Monoimplant's performance against predefined quantitative acceptance criteria.
However, I can extract the information relevant to the device and its regulatory submission:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or report specific device performance metrics in the way a clinical study or performance verification test report would. Instead, it claims substantial equivalence to predicate devices based on shared characteristics. The "performance" in this context refers to functional performance being "substantially equivalent" to the predicate devices.
| Characteristic | Acceptance Criteria (implied by substantial equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate devices (stabilization of removable prostheses on the lower arch) | The Leone Monoimplant is indicated for stabilization of removable prosthesis on the lower arch, inserted in the mandible between two foramina, requiring four monoimplants. This is equivalent to the long-term application of IMTEC Sendax MDI and MDI Plus for overdenture stabilization and the Leone Implant System's anchorage for removable prosthesis. |
| Material | Biocompatible Titanium Alloy for surgical use. | Composed of biocompatible titanium alloy for surgical use, identical to predicate devices. |
| Design | Substantially equivalent in design to predicate devices. | One-piece endosseous dental implant with endosseous and abutment portions; self-tapping screw with sandblasted surface; smooth tapered neck and ball-shaped top. Substantially equivalent to predicate devices. |
| Physical Characteristics | Substantially equivalent to predicate devices. | Offered in different sizes. Substantially equivalent to predicate devices. |
| Functional Performance | Substantially equivalent to predicate devices. | Functional performance is substantially equivalent to predicate devices. |
| Labeling | Substantially equivalent to predicate devices. | Substantially equivalent to predicate devices. |
| Potential Adverse Effects | No new issues of safety or effectiveness compared to predicate devices. | Raises no new issues of safety or effectiveness. |
| Sterility | Sterile | Supplied as sterile, equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set sample size or data provenance is mentioned as this is a 510(k) summary primarily focused on demonstrating equivalence based on design and material comparisons, not a specific performance study with a test set.
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. This document does not describe a study involving expert review for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set adjudication method is mentioned.
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 dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The regulatory submission relies on comparison to predicate devices, not on establishing a "ground truth" through clinical or pathological assessment in the context of a new performance study. The "truth" here is essentially the established safety and effectiveness of the existing predicate devices.
8. The sample size for the training set:
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a medical device, not an AI model.
In summary: The provided document is a 510(k) premarket notification for a dental implant. It aims to demonstrate substantial equivalence to already-marketed predicate devices, not to present a new performance study with specific acceptance criteria, test sets, or ground truth assessments. The "acceptance criteria" are implicitly met by demonstrating this substantial equivalence in terms of intended use, materials, design, and functional performance.
§ 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.