Search Results

The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic reconstruction 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 MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: Mk III 3.3mm, Threaded HL Series 3.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm.

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.

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 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.

Here's a breakdown of the acceptance criteria and study information for the Atlantis™ Abutment for 3i MicroMini Implant, based on the provided text, recognizing that this is a 510(k) summary and not a full study report.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical trial for device-specific performance criteria. Therefore, explicit "acceptance criteria" and "device performance" in the typical sense of a clinical study with statistical endpoints are not present. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence in "intended use, material, design and performance" to the predicate devices. The "reported device performance" is essentially the statement that it meets these equivalence criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify a separate "test set" sample size in the context of a clinical performance study. This is a 510(k) submission, primarily relying on comparison to predicate devices and (implied) bench testing rather than a new clinical trial.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance supporting the substantial equivalence would come from the manufacturer's internal testing (mechanical, material characterization) and comparison to the known characteristics of the predicate devices. There is no mention of country of origin for clinical data as no clinical study demonstrating new performance data is described for this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

• Number of Experts: Not applicable. There is no mention of experts establishing ground truth for a clinical test set in this 510(k) summary. The "ground truth" for substantial equivalence is based on engineering principles, material science, and regulatory comparison.

4. Adjudication Method for the Test Set

• Adjudication method is not applicable as there is no described clinical test set involving human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No, an MRMC comparative effectiveness study was not done. This document pertains to a dental implant abutment, where performance is typically assessed through mechanical testing and equivalence to existing devices, not through human reader interpretation of images or data that would necessitate an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a passive mechanical component (an abutment for a dental implant), not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for this 510(k) submission is the established performance and safety profiles of the predicate devices (Atlantis Abutments K981858 and 3i Osseotite NT Dental Implant System K014235). The applicant aims to demonstrate that the new device's material, design, intended use, and performance are equivalent to these legally marketed devices. This would typically be supported by:
  • Mechanical Testing Data: (Implied) to show comparable strength, fatigue resistance, and fit.
  • Material Characterization: (Stated: Ti 6Al 4V ELI, ASTM F-136 compliance).
  • Design Specifications: Showing compatibility with target implant systems.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI/ML algorithm, no ground truth establishment for such a set is relevant.

Ask a specific question about this device