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The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's NobelProcera Anquiated Screw Channel Abutment Replace is an endosseous dental implant abutment. The abutment attaches directly to Nobel Biocare dental implants with a conical connection and provides a platform for restoration.
Nobel Biocare's NobelProcera Angulated Screw Channel Abutment Replace is designed and made individually to fit the individual requirements for each patient. The abutments are a two piece design with an adapter portion made of titanium vanadium alloy and an abutment portion made of zirconium oxide. The screw channel can be angulated between 0° and 25° as required.
The provided text describes the 510(k) submission for the "NobelProcera Angulated Screw Channel Abutment Replace". This is a medical device clearance submission, not a study evaluating a diagnostic device or an AI algorithm. Therefore, many of the requested elements for describing a study on acceptance criteria and device performance (e.g., sample size, expert ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.
However, I can extract the relevant information regarding the device's acceptance criteria and how compliance was demonstrated for this type of medical device clearance.
Here's a breakdown based on the provided text, focusing on the available information:
Description of Acceptance Criteria and Device Performance for NobelProcera Angulated Screw Channel Abutment Replace
This document describes the 510(k) submission for the NobelProcera Angulated Screw Channel Abutment Replace, an endosseous dental implant abutment. The acceptance criteria for this type of device primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device and meeting specific performance standards, mainly fatigue testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied from the document) | Reported Device Performance/Compliance |
|---|---|---|
| Substantial Equivalence | Demonstrate similarity in design, construction, anatomical site, platform compatibility, screw channel, device material, and indications for use to a predicate device. | The submission claims "The information provided in this submission demonstrates that the device is substantially equivalent to the predicate device." |
| Predicate Device | Nobel Biocare - Esthetic Zirconia Abutment (K031719) | The new device and predicate device have similarities as outlined in the "Comparison of Technological Characteristics" table. Differences (e.g., variable vs. fixed screw channel, different material for implant adapter vs. whole abutment) were deemed not to raise new questions of safety or effectiveness. |
| Fatigue Testing | Compliance with FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | "Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance..." |
| Biocompatibility | (Not explicitly stated, but implied for an implantable device) | (Information not provided in the excerpt, but typically required for such devices) |
| Labeling | Accurate and not misleading, and adherence to "Indications for Use" statement. | The Indications for Use statement is provided and is part of the submission reviewed by FDA. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This document does not describe a "test set" in the context of a diagnostic algorithm or clinical trial. The testing primarily involved non-clinical fatigue testing. The specific number of abutments subjected to fatigue testing is not provided in this excerpt.
- Data Provenance: The testing was "non-clinical" and involved in-vitro fatigue testing as per FDA guidance. The provenance is internal testing conducted by Nobel Biocare or a contracted lab. The document does not specify a country of origin for the "data" itself, but the applicant (Nobel Biocare AB) is based in Sweden.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not a study requiring expert ground truth for a diagnostic outcome. The "ground truth" for fatigue testing is defined by the physical failure criteria outlined in the relevant FDA guidance document for dental implants and abutments.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical study or human-based assessment requiring an adjudication method. The evaluation was based on objective mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical component, not a diagnostic tool where human readers assess cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical component, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for demonstrating safety and effectiveness was primarily based on compliance with a regulatory guidance document for mechanical fatigue testing (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments). This guidance typically specifies load levels, cycles to failure, and other mechanical performance metrics that devices must meet.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML or diagnostic device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.)