(104 days)
The ANKYLOS® Temporary Abutment Balance is an anatomical abutment which is indicated for the fabrication of provisional crowns or bridges over max. 2 bridge pontics. The ANKYLOS® Temporary Abutment Balance is a short-term provisional for esthetic soft-tissue contouring.
The ANKYLOS® Temporary Abutment Balance is part of the ANKYLOS® Dental Implant System. The temporary abutment is available in the sizes "small" (D5.5) and "large" (D7) and with the gingival margins of 1.5 and 3. The ANKYLOS® Temporary Abutment Balance can be used in straight and angled implant positions. The ANKYLOS® Temporary Abutment Balance is made of plastic material.
The provided text is a 510(k) summary for the ANKYLOS® Temporary Abutment Balance, which is a dental implant component. This document focuses on demonstrating substantial equivalence to predicate devices based on material composition and prior use, rather than presenting a performance study with acceptance criteria in the context of AI/ML or diagnostic device evaluation.
Therefore, the requested information elements related to AI/ML study design (such as test set sample size, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
However, I can extract information regarding the device description, intended use, and the basis for the declaration of safety and effectiveness, which serves as the "study" in this context.
Here's a summary based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for dental use and do not cause cytotoxicity. | Biocompatibility: The plastic material used for the ANKYLOS® Temporary Abutment Balance has been evaluated and passed biocompatibility testing for cytotoxicity. The materials and manufacturing methods are identical to legally marketed devices, indicating no additional biocompatibility testing was necessary for the final product. |
| Functional Equivalence: Device components, materials, and manufacturing process are comparable to legally marketed devices. | Functional Equivalence: All components found in the ANKYLOS® Temporary Abutment Balance have been used in legally marketed devices. The materials and manufacturing methods are identical to legally marketed devices. Previous biocompatibility tests support safety and effectiveness. |
| Intended Use: The device performs as an anatomical abutment for provisional crowns/bridges and esthetic soft-tissue contouring. | Intended Use: The device is indicated for fabrication of provisional crowns or bridges over a maximum of 2 bridge pontics, and as a short-term provisional for esthetic soft-tissue contouring. (The "performance" is considered equivalent to predicates for these uses due to the substantial equivalence claim). |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This submission is based on substantial equivalence through material and design comparison with predicate devices, not a performance study involving a "test set" in the diagnostic sense. The "data provenance" refers to the prior use of the materials and components in other legally marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. No "ground truth" establishment by experts for a test set was performed as part of this submission. The basis for safety and effectiveness relies on material properties and comparison to predicate devices, not a diagnostic assessment.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or adjudication method was used for this submission.
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 component, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Not Applicable. This device has no AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "truth" in this context is the established safety and effectiveness of the component materials and design, demonstrated through prior use in legally marketed devices and successful biocompatibility testing of the material. There isn't a diagnostic "ground truth."
8. The sample size for the training set.
- Not Applicable. There is no AI training set for this physical device.
9. How the ground truth for the training set was established.
- Not Applicable. There is no AI training set or associated ground truth establishment for this physical 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.)