(432 days)
The Nobel Biocare PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.
NobelProcera PEEK Abutments are endosseous dental implant abutments. They are made from PEEK in natural color or white. The PEEK Abutments are available in a variety of preformed and customized shapes that can be used either as provisional abutments or as healing abutments. The customized PEEK Abulments must be straight, further design limitations for customized shapes are given in the Instructions for Use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NobelProcera PEEK Abutments:
Acceptance Criteria and Study Analysis for NobelProcera PEEK Abutments (K120954)
1. Table of Acceptance Criteria and Reported Device Performance:
The provided documentation does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the NobelProcera PEEK Abutments. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. This equivalence is based on a comparison of characteristics rather than performance metrics from a clinical study.
| Characteristic | Acceptance Criterion (Implied by Predicate) | Reported Device Performance (NobelProcera PEEK Abutments) |
|---|---|---|
| Material | PEEK | PEEK |
| Color | Natural (Branemark) / White (Neo Implant) | Natural & White |
| Attachment Method | Screw retained; Engaging & Non Engaging | Screw retained; Engaging & Non Engaging |
| Intended Use | Healing abutment (Neo Implant), Provisional abutment (Both) | Healing abutment, Provisional abutment |
| Duration of Use | 90 days (Branemark) / 180 days (Neo Implant) | 180 days |
| Implant/Abutment Connection | Nobel Biocare - External Hex, Internal Conical, Internal Tri-lobe (Branemark) / Neoss - Internal Hex (Neo Implant) | Nobel Biocare - External Hex, Internal Conical, Internal Tri-lobe |
| Abutment Profile | Straight walled; Various anatomical shapes | Provisional: Straight walled or designed with Procera system; Healing: Various anatomical shapes or individually designed with Procera system |
| Biocompatibility | Demonstrated in predicate devices | Performed following ISO 10993 (Cytotoxicity: ISO 10993-5) |
| Sterilization | Demonstrated in predicate devices | Performed in accordance with ISO 17665 |
2. Sample Size Used for the Test Set and Data Provenance:
- No clinical test set was used to demonstrate safety and effectiveness. The submission explicitly states: "No Clinical test data was used to support the decision of safety and effectiveness."
- Instead of a clinical test set, the device's equivalence was established through non-clinical testing (biocompatibility and sterilization) and a comparison of device characteristics to predicate devices already on the market.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no clinical test data was used, there was no "ground truth" established by experts for a test set in the context of device performance. The assessment was based on comparing material properties, design, and indications for use against predicate devices.
4. Adjudication Method for the Test Set:
- Not applicable. No test set requiring expert adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted as no clinical studies involving human readers or assessment of AI performance were performed. This device is a dental implant abutment, not an AI/imaging diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- No. This is a physical medical device (dental abutment), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used:
- Implied Regulatory Ground Truth: The "ground truth" in this context is the regulatory acceptance of the predicate devices. The new device is deemed safe and effective because its characteristics (material, design, intended use, non-clinical performance) are substantially equivalent to devices that have already demonstrated safety and effectiveness and are legally marketed.
- For non-clinical tests (biocompatibility, sterilization), the ground truth is established by the standards themselves (ISO 10993, ISO 17665), where meeting the parameters of these standards indicates acceptable performance.
8. Sample Size for the Training Set:
- Not applicable. This device does not involve a training set as it is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for this device, ground truth establishment for it is irrelevant.
§ 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.)