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510(k) Data Aggregation
(268 days)
LEONE SPA
The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.
The Leone orthodontic mini implant is a medical device made of stainless steel for surgical use (ISO 5832-1). The orthodontic mini implant is a one-piece endosseous mini implant where the endosseous portion is a right-hand thread screw, while the head section is made of a smooth tapered neck. It is available in different diameters, lengths and head shapes.
Here's an analysis of the provided text regarding the Leone orthodontic mini implant.
Acceptance Criteria and Study for the Leone Orthodontic Mini Implant
The provided 510(k) summary for the Leone orthodontic mini implant (K071490) focuses on demonstrating substantial equivalence to a predicate device, rather than presenting specific performance acceptance criteria and a detailed study proving the device meets those criteria. In the context of a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The "study" described herein is the comparison and testing performed to establish this substantial equivalence.
1. Table of Acceptance Criteria and the Reported Device Performance
As mentioned, explicit, quantitative acceptance criteria are not stated in this summary. Instead, the "acceptance" is based on the new device being comparable to the predicate device across several key characteristics. The reported device performance is presented through a direct comparison with the predicate.
| Characteristic | Acceptance Criterion (Implicitly "Substantially Equivalent to Predicate") | Reported Device Performance (Leone Orthodontic Mini Implant) | Predicate Device Performance (Dentos AbsoAnchor) |
|---|---|---|---|
| Product Code | Must match the predicate device's product code. | DZE | DZE |
| Regulation No. | Must match the predicate device's regulation number. | 872.3640 | 872.3640 |
| Intended Use | Must be the same or highly similar to the predicate device. | Provide a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. Used temporarily in maxillary and mandibular bone, removable after treatment. | Provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. |
| Material | Must be biocompatible and suitable for the intended use. | Surgical stainless steel ISO 5832-1 | Surgical titanium alloy ISO 5832-3 |
| Biocompatibility | Must be biocompatible. | Biocompatible. | Biocompatible. |
| Sterility | Must be provided in a state that allows for appropriate sterilization. | Non-sterile. Recommended to sterilize with steam autoclave before use. | Non-sterile. Steam sterilize before use. |
| Performance | Supported by results of testing performed to demonstrate equivalence. | Concluded to be substantially equivalent based on testing (details not provided in summary). | N/A (predicate device is already marketed) |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not explicitly state the sample size used for any testing. It mentions "results of the testing performed" but does not detail the nature of these tests (e.g., mechanical, biocompatibility, in-vivo, etc.), their design, or the sample size of any materials or subjects involved.
Regarding data provenance, the summary does not provide this information. Given the nature of a 510(k) for a device like an orthodontic mini implant, the "testing performed" would typically involve laboratory (bench) tests to evaluate mechanical properties and biocompatibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) summary. The submission is a regulatory filing demonstrating substantial equivalence to a predicate device, not a clinical study requiring expert consensus on a test set to establish ground truth for a diagnostic or AI device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable. The device is an orthodontic mini implant, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. For this type of medical device 510(k), the "truth" is established through:
- Compliance with recognized standards: Such as ISO 5832-1 for surgical stainless steel, which inherently assumes material suitability.
- Bench testing: To verify mechanical properties (strength, fatigue, etc.) of the implant. The "ground truth" for these would be the specified engineering requirements or comparison to the predicate.
- Biocompatibility testing: To ensure the material is non-toxic and suitable for implantation. These tests have defined endpoints that serve as their "ground truth."
The summary states equivalence is "supported by the results of the testing performed," implying these types of tests were conducted, but the specific "ground truth" for each is not detailed.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an orthodontic mini implant's regulatory submission, as it is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set.
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(58 days)
LEONE SPA
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.
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(357 days)
LEONE SPA
The Leone Implant System is indicated for single or multiple tooth replacement, or for use in terminal or intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It can work as an abutment system for partial/total prosthetic restorations or as an anchorage system for removable prosthodontics.
The Leone implant system is composed of a fixture and an abutment joined together by a self locking tapered connection due to a Morse cone and a hexagon. The prosthesis is then placed over the abutment.
The provided text describes a 510(k) premarket notification for the "Leone Implant System," a dental implant device. The submission focuses on establishing substantial equivalence to existing legally marketed predicate devices rather than proving specific performance criteria through a study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document.
The document states that the conclusion is based on:
- Intended Use: Consistent with predicate devices.
- Materials: Titanium (same as predicate devices).
- Biocompatibility: Biocompatible (same as predicate devices).
The acceptance criteria for a 510(k) submission like this are primarily demonstrating that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.
Summary of what is present:
- Acceptance Criteria and Reported Device Performance: Not presented as a list of quantitative metrics. The "acceptance criteria" are effectively demonstrating substantial equivalence in intended use, material, and biocompatibility, which the submitter claims is met.
- Study Details: No study is described that tests the device against specific performance acceptance criteria. The submission is a comparison to predicate devices.
- Sample Size for Test Set: Not applicable, as no performance study is detailed.
- Data Provenance: Not applicable.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
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