(14 days)
The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants:
• 3i® 3.75
- Lifecore® Biomedical Restore 3.75
· Zimmer® Dental Taper-lock 4.0
· Sterngold Implamed® 3.75
Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The Procera® Implant Bridge framework is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.
Procera® Implant Bridges are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium.
The Procera® Implant Bridge implant interfaces are modeled after similar interfaces currently available for the predicate devices listed.
This document is a 510(k) premarket notification for a dental device, the Procera® Implant Bridge. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.
Therefore, the requested information elements related to sample size, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable as they are not typically part of a 510(k) submission for this type of device. The "study" here is essentially the comparison of the new device to predicate devices based on design, materials, and intended use.
Here's an analysis based on the provided text, focusing on what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This type of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy) is not elaborated upon in a 510(k) for a physical medical device like a dental implant bridge. The "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to predicate devices. The performance is assessed by confirming that the new device functions similarly and uses comparable materials and design principles as already approved devices.
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (as per submission) |
|---|---|
| Material Equivalence: Made of substantially equivalent materials to predicate devices. | "The Procera® Implant Bridge is made entirely of titanium." This is implicitly compared to the materials of the predicate devices. |
| Design Equivalence: Similar design and intended function to predicate devices. | "Nobel Biocare's Procera® Implant Bridge is a bridge framework that attaches to implants or abutments. The Procera® Implant Bridge framework is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer." |
| "The Procera® Implant Bridge implant interfaces are modeled after similar interfaces currently available for the predicate devices listed." | |
| Intended Use Equivalence: Same indications for use as predicate devices. | "The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring function." |
| "In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants: 3i® 3.75, Lifecore® Biomedical Restore 3.75, Zimmer® Dental Taper-lock 4.0, Sterngold Implamed® 3.75." (This aligns with the function of connecting to existing implant systems, similar to predicates.) | |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | The FDA's letter of "substantial equivalence" (K043042) implies this criterion was met. This is a regulatory finding, not a specific performance metric. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in this context. A 510(k) for a dental device like this typically relies on design verification and validation tests (bench testing), material specifications, and comparison to predicate devices, rather than a "test set" of patient data in the way an AI/software device would have. The data provenance would be internal engineering and materials testing, not patient data in the sense of a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. Ground truth, in the context of expert consensus, is critical for AI/software validation. For a physical dental device, the "truth" is established by manufacturing specifications, material science, and clinical performance of predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable. No test set requiring expert adjudication 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
An MRMC study is not applicable. This type of study is relevant for AI-powered diagnostic tools or decision support systems. The Procera® Implant Bridge is a physical prosthetic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant bridge, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device primarily relies on:
- Engineering specifications and design parameters: Ensuring the bridge meets specific dimensions, strength requirements, and fits existing implant systems.
- Material properties: Verifying the titanium used meets biomedical standards.
- Clinical history of predicate devices: The fact that the predicate devices (e.g., Procera® Implant Bridge K041236, 3i Dental Abutment K032263, etc.) are already legally marketed and have established safety and effectiveness forms a crucial part of the "truth" for substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. No training set exists for this device.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)