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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 Atlantis Abutment for 3i Certain MicroMini Implant is compatible with 3i Osseotite NT® Certain and Parallel Walled Implants both with 3.25 mm diameters.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant fixture.

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™ MicroMini 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 Osseotite NT® Certain™ and Parallel Walled Implants both with a 3.25mm diameter.

The provided text is a 510(k) summary for a medical device, specifically a dental implant abutment. It describes the device, its intended use, and its claim of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) process for this type of device (Class II, dental implant abutment) primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials with acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it is not present in the document:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on:

• Device Name: Atlantis™ Abutment for 3i Certain™ MicroMini Implant
• Manufacturer: Atlantis Components Inc.
• Intended Use: To support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prosthesis in the mandible or maxilla, with the prosthesis being cement-retained. The abutment screw secures the abutment to the endosseous implant.
• Materials: Titanium grade Ti-6Al-4V ELI (Meets ASTM Standard F-136).
• Compatibility: Compatible with 3i Osseotite NT® Certain™ and Parallel Walled Implants (3.25mm diameter).
• Predicate Devices: Atlantis Abutment and Abutment Screw (K981858), Atlantis Abutment for 3i Certain Implant (K051011), and 3i Osseotite NT Dental Implants (K014235).
• Basis for Substantial Equivalence: Claimed equivalence in intended use, material, design, and performance to the listed predicate devices.

The FDA's letter (pages 2-3) confirms the review of the premarket notification and the determination of substantial equivalence, allowing the device to be marketed. This regulatory pathway does not typically require the detailed performance study information you requested, which is more common for diagnostic AI/ML devices or novel high-risk devices.

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