(82 days)
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for 3i Certain™ Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Certain Standard Implants with 4.1mm, 5.0mm, 6.0mm diameters; the OSSEOTITE® XP Certain Implants with 5.0mm and 6.0mm diameters; and the OSSEOTITE® NT® Certain™ Implants with 4.0mm, 5.0mm and 6.0mm diameters.
The provided text describes a 510(k) premarket notification for a medical device called the Atlantis™ Abutment for 3i Certain™ Implant. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
Therefore, the document does not contain information regarding:
- Acceptance criteria and reported device performance in a table. The summary focuses on equivalence to a predicate device rather than specific performance metrics against pre-defined acceptance criteria.
- A study that proves the device meets acceptance criteria. No specific study design, methodology, or results are presented that would demonstrate the device meeting particular performance targets.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on:
- Device Identification: Trade Name, Common Name, Classification Name, Regulation Number, Product Code.
- Predicate Device: Identification of the legally marketed device to which equivalence is claimed.
- Description of the Device: Material used (Titanium grade Ti-6A1-4V ELI), compatibility with various implant diameters, and its function as an abutment and abutment screw.
- Intended Use: As an accessory to an endosseous implant to support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement-retained prostheses.
- Basis for Substantial Equivalence: Stating that the device is substantially equivalent in intended use, material, design, and performance to the predicate device cleared under K981858.
- Regulatory Outcome: FDA's determination of substantial equivalence, allowing the device to be marketed.
In summary, this document is a regulatory submission demonstrating equivalence, not a clinical or performance study report with specific acceptance criteria and detailed study results. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria, study details, and ground truth establishment.
§ 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.)