(15 days)
Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.
The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant.
Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.
Here's an analysis based on the provided document, addressing your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for the Procera® Abutment Octagon. For devices approved via the 510(k) pathway, the primary "acceptance criterion" from a regulatory perspective is Substantial Equivalence to a legally marketed predicate device. This means the new device is as safe and effective as a legally marketed device that is not subject to PMA.
The document does not outline specific, quantitative performance acceptance criteria (e.g., strength thresholds, fatigue limits) for the Procera® Abutment Octagon, nor does it present detailed study results with numerical performance metrics against such criteria. This is typical for a 510(k) summary, which focuses on demonstrating equivalence rather than establishing new performance benchmarks.
Instead, the study mentioned (though not explicitly detailed) would have aimed to demonstrate that the new device performs equivalently to the identified predicate devices in its intended use.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Summary from document) |
|---|---|
| Substantial Equivalence to Predicate Devices (K031719, K971706, K033243) in terms of safety and effectiveness for stated indications. | The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This implies the device's performance, as demonstrated through testing (though not detailed here), was found to be comparable and acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data's provenance (e.g., country of origin, retrospective or prospective). This level of detail is typically found in the full 510(k) submission, not the summary document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the involvement of experts for establishing ground truth for a test set. In the context of dental implants, performance testing often involves mechanical and biocompatibility evaluations rather than interpretation by human experts.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for a test set. This is not applicable given the type of device and the information provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
A MRMC comparative effectiveness study was not done or mentioned. This type of study is typically relevant for interpretative devices (e.g., AI for medical imaging), not for a physical device like a dental abutment. The effectiveness of the abutment would be assessed through mechanical testing and clinical use (post-market surveillance).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used
For this type of physical device, "ground truth" would typically be established by:
- Engineering specifications and test standards: Conformance to recognized standards for mechanical strength, fatigue, material properties (e.g., ISO standards for dental implants and components).
- Biocompatibility testing: In vitro and in vivo studies to ensure the materials are safe for use in the human body.
- Clinical performance (implicitly via predicates): The understanding that the predicate devices have a history of safe and effective use provides a baseline for the "ground truth" of performance.
The document does not explicitly state a specific "ground truth" type but implies adherence to safety and effectiveness demonstrated by predicate devices and relevant standards.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical dental abutment, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical dental abutment, not an AI/ML algorithm.
§ 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.)