(74 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.
This device is compatible with the following manufacturers' implant systems having an external hex with flat-to-flat dimensions of 2.7mm or greater: Nobel Biocare, 3i, Lifecore, Sterngold ImplaMed, Innova, and BioHorizons.
The Atlantis Abutment may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
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™ Abutment in Zirconia is made of the biocompatible material, yttriastabilized tetragonal zirconia polycrystals (Y-TZP) (Meets ISO standards 6872 & 13356) and the abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136).
The provided document K052070 for the Atlantis™ Abutment in Zirconia does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity. This document is a 510(k) pre-market notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on detailed performance studies with acceptance criteria typically associated with AI/ML-driven devices.
Here's why the requested information is not available in the provided text:
- Device Type: The Atlantis™ Abutment in Zirconia is a physical medical device (an endosseous dental implant abutment), not a software or AI/ML-driven device. Its evaluation for market clearance relies on material properties, mechanical testing (implied by meeting ISO and ASTM standards), biocompatibility, and substantial equivalence to a predicate device. Performance metrics like sensitivity or specificity are not applicable to this type of device in the same way they would be for diagnostic or AI-assisted systems.
- 510(k) Process: The 510(k) pathway for medical device clearance primarily requires the applicant to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing intended use, materials, design, and performance data from internal testing or adherence to recognized standards, rather than extensive clinical efficacy studies with specific performance acceptance criteria for diagnostic output.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of the input document, nor can I answer the questions related to sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not addressed for this particular device in this regulatory submission.
§ 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.)