Search Results
Found 3 results
510(k) Data Aggregation
(30 days)
XIVE DENTAL IMPLANT SYSTEM MULTIPLE
The XiVE® Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.
The XiVE® Dental Implant System consists of subgingival threaded dental imolants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIADENT Surface M2.1. The XiVE® Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures. In the edentulous mandible, the XiVE® dental implants are indicated for immediate loading procedures using the standard protocol.
The provided document is a 510(k) summary for the FRIADENT GmbH XIVE® Dental Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria via a clinical study with an AI component. Therefore, much of the requested information regarding AI device evaluation is not applicable to this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific performance metrics against such criteria in the way a clinical study for an AI device would. The core of this 510(k) is to demonstrate "substantial equivalence." The "performance evaluations" mentioned are general and refer to the device performing "as intended," not against specific numerical thresholds.
| Acceptance Criteria (Not Explicitly Stated for this 510(k)) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| (Implicit) Substantial Equivalence to Predicate Devices | The device is substantially equivalent to the predicate devices in terms of design, materials, mechanical strength, prosthetic and laboratory options, and intended use. |
| (Implicit) Performs as Intended | "Performance evaluations of the XiVE® dental implant system show that the device performs as intended." |
| (Implicit) Biocompatibility / Safety (as per predicate) | Constructed of CP-2 titanium, which is consistent with existing cleared devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI device. The comparison is primarily based on technological characteristics and intended use relative to predicate devices. The "performance evaluations" mentioned are not detailed as a specific study with a quantifiable sample size.
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 submission does not involve AI model development or ground truth establishment by experts in the context of a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set or adjudication for an AI device.
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 is not an AI device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no AI model requiring ground truth. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI device or training set.
Summary based on the provided document:
The K032158 submission for the XiVE® Dental Implant System focuses on demonstrating substantial equivalence to previously cleared predicate devices (K013867 and K021318). The primary argument for equivalence is that the device has the same design, materials (CP-2 titanium), mechanical strength, prosthetic options, instructions for use, and intended use as the predicate devices. The only stated difference is a change in the surface morphology to the "FRIADENT Surface M2.1." The submission asserts that "Performance evaluations of the XiVE® dental implant system show that the device performs as intended." This implies that internal testing or existing knowledge about the materials and design support its function, but no detailed study or specific quantitative acceptance criteria are provided in this summary. The FDA's clearance letter confirms their agreement that the device is substantially equivalent to the predicate.
Ask a specific question about this device
(68 days)
XIVE DENTAL IMPLANT SYSTEM
The XiVE Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.
The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single tooth replacement, fixation of bridges and complete dentures and for immediate loading procedures using four implants in the anterior mandible.
The provided text describes a 510(k) premarket notification for the FRIADENT GmbH XiVE® Dental Implant System. This type of submission is for medical devices, not AI/ML algorithms, and therefore the information requested about acceptance criteria and study design for AI/ML performance metrics is not applicable to this document.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device already legally marketed, rather than establishing de novo performance criteria through extensive clinical trials as would be required for a novel AI/ML device.
Here's an analysis based on the provided text, highlighting why the requested AI/ML specific information cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in the sense of performance thresholds for an AI/ML algorithm (e.g., specific sensitivity, specificity, or AUC targets). Instead, the "performance" demonstrated is that the XiVE Dental Implant System is substantially equivalent to legally marketed predicate devices.
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance |
|---|---|
| Same intended use as predicate device | XiVE® Dental Implant System "is indicated as follows: once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XIVE dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement." (Matches predicate's intended use). |
| Similar technological characteristics to predicate device | "The XiVE® dental implant is identical to the current XiVE® Dental Implant System in terms of design, materials, coatings, prosthetic options and mechanical attributes. The XiVE® dental implant is substantially equivalent to the FRIADENT FRIALOC® Dental Implant System in terms of intended use." "The XiVE dental implant system was tested for compressive and static strength and finite element analysis." (These tests are to demonstrate similar characteristics, not AI performance). |
2. Sample size used for the test set and the data provenance
Not applicable for AI/ML performance. The submission relies on mechanical testing (compressive and static strength, finite element analysis) of the physical implant, which does not involve a "test set" of data in the AI/ML sense. No patient data provenance information is provided for these mechanical tests, as they are likely conducted in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for AI/ML performance. No ground truth determination by experts for AI/ML performance is described.
4. Adjudication method for the test set
Not applicable for AI/ML performance. No adjudication method for AI/ML data is described.
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 physical dental implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for a physical medical device typically relates to its material properties, biocompatibility, and mechanical performance. The document only mentions:
- Mechanical Testing: Compressive and static strength, and finite element analysis. These tests likely follow established industry standards to ensure the implant's durability and structural integrity.
- Substantial Equivalence: The primary "ground truth" from a regulatory perspective for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
8. The sample size for the training set
Not applicable for AI/ML performance. No training set for an AI/ML algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable for AI/ML performance. No ground truth for an AI/ML training set is mentioned.
In summary, the provided document pertains to a traditional physical medical device (dental implant) seeking 510(k) clearance based on substantial equivalence to existing devices, not an AI/ML powered device. Therefore, the specific criteria for evaluating AI/ML algorithm performance are entirely absent and not relevant to this submission.
Ask a specific question about this device
(114 days)
XIVE DENTAL IMPLANT SYSTEM
Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations.
The XiVE Dental Implant System consists of subgingival threaded dental implants in 3.4 - 5.5mm diameters with 8 - 18mm lengths. The implants are coated with the FRIOS Deep Profile Surface. The XiVE Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for two stage procedures for single twth replacement and the fixation of bridges and complete dentures.
The provided text is a 510(k) summary for the FRIADENT GmbH XiVE Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them in the context of performance metrics that would typically be associated with AI/ML-based medical devices (e.g., sensitivity, specificity, AUC).
Instead, the document emphasizes:
- Substantial Equivalence: The core of the submission is to demonstrate that the XiVE Dental Implant System is substantially equivalent to legally marketed predicate devices (Nobel BioCare Branemark System Standard 3.75mm Fixture and FRIADENT GmbH FRIALIT-2 Dental Implant With Deep Profile Surface) in terms of design, materials, coatings, prosthetic options, mechanical strength, functionality, and intended use.
- Safety and Effectiveness: The document states, "Performance evaluations of the XiVE dental implant system show that the device performs as intended." and mentions "The XiVE dental implant system was tested for compressive and static strength and finite element analysis." However, it does not provide specific acceptance criteria values or detailed study results for these tests.
Given the nature of the provided document (a 510(k) summary for a dental implant, not an AI/ML device), many of the requested points are not applicable or cannot be extracted. I will address the points based on the information available and note when information is not present in the document.
Acceptance Criteria and Study for FRIADENT GmbH XiVE Dental Implant System
The provided document primarily focuses on demonstrating substantial equivalence of the XiVE Dental Implant System to predicate devices rather than presenting specific performance metrics against pre-defined acceptance criteria, especially in the way an AI/ML device would. The "performance evaluations" mentioned are broadly stated and do not include quantitative acceptance criteria or detailed study results.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance values similar to what would be found for an AI/ML diagnostic device (e.g., sensitivity > X%, specificity > Y%). The evaluation primarily rests on demonstrating equivalence to predicate devices.
The closest to "acceptance criteria" and "performance" mentioned are:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: To predicate devices in design, materials, coatings, prosthetic options, and intended use. | "The XiVE® dental implant is substantially equivalent to the current FRIALIT-2® Dental Implant Systems in terms of design, materials, coatings, prosthetic options and intended use." |
| "The XiVE® dental implant is substantially equivalent to the Nobel BioCare Branemark 3.75mm dental implant in terms materials, functionality, mechanical strength and intended use." | |
| Mechanical Strength: Demonstrated through testing (compressive, static, finite element analysis). | "The XiVE dental implant system was tested for compressive and static strength and finite element analysis." |
| "Performance evaluations of the XiVE dental implant system show that the device performs as intended." | |
| Intended Use: Supports single tooth, bridge and overdenture restorations once osseointegrated. | "Once the XiVE Dental Implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations." (Stated as intended use and implicitly accepted through equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing describes generic "performance evaluations" and "testing for compressive and static strength and finite element analysis" but does not detail the size of any test sets (e.g., number of implants tested) or the provenance of the data. Given it's a physical implant, "data provenance" in the sense of patient data is not directly applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. This concept typically applies to diagnostic devices where expert review (e.g., radiologists, pathologists) establishes a "ground truth" for evaluating algorithm performance. For a physical dental implant, performance is assessed through engineering tests (mechanical, material, biocompatibility) and clinical outcomes, not expert-adjudicated ground truth on a test image/data set.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, an adjudication method like 2+1 or 3+1 is relevant for establishing ground truth in diagnostic studies, not for the physical and mechanical testing of a dental implant.
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 and not provided. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for AI/ML-based diagnostic or assistive devices, not for a physical dental implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a physical dental implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the XiVE Dental Implant System is established through:
- Engineering specifications and standards: For material properties, mechanical strength (compressive, static), and finite element analysis.
- Biocompatibility testing: To ensure safety in the body (implied, common for implants).
- Clinical outcomes: While not detailed, ultimately, successful osseointegration and long-term support of restorations in patients would be the ultimate "ground truth" for its intended function.
The document implicitly relies on these types of "ground truth" by stating the device "performs as intended" and is "substantially equivalent" to devices proven safe and effective.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of a physical dental implant device. This concept applies to AI/ML algorithms.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As there is no training set, there is no ground truth establishment for it.
In summary, the provided document is a 510(k) premarket notification summary for a physical dental implant. It demonstrates substantial equivalence to predicate devices based on design, materials, mechanical properties (tested, but not detailed), and intended use. The questions posed are largely tailored for AI/ML-based medical devices, which the XiVE Dental Implant System is not. Therefore, specific details regarding acceptance criteria as quantitative performance metrics, sample sizes for test/training sets, expert adjudication, or AI performance metrics are absent and not relevant to this type of device submission.
Ask a specific question about this device
Page 1 of 1