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510(k) Data Aggregation
(213 days)
ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE
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 maxillated 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: Nobel Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage.
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 Nobel Replace Interface 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 Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.
The provided text is a 510(k) summary for the Atlantis™ Abutment for Nobel Replace Interface. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and performance metrics in the way a clinical trial or software validation study would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set sample size, how training set ground truth was established) are not applicable (N/A) because this submission format does not require such detailed efficacy or performance study data.
The acceptance criteria for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. This is primarily achieved through comparisons of intended use, material, design, and performance, rather than through specific quantitative metrics of a clinical study.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description of Acceptance Criteria (Implied by 510(k)) | Reported Device Performance/Comparison (from text) |
|---|---|---|
| Intended Use | Must be substantially equivalent in intended use to predicate device(s). | "substantially equivalent in intended use... to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively." |
| Intended use described as: accessory to an endosseous implant to support a prosthetic device in partially or completely edentulous patients, supporting single/multiple tooth prosthesis, cement-retained. | ||
| Materials | Must use materials substantially equivalent to or accepted for predicate device(s). | "made from Titanium grade Ti-6Al-4V ELI (Meets ASTM Standard F-136)." This implies equivalence or compliance with recognized standards. |
| Design | Must be substantially equivalent in design to predicate device(s). | "substantially equivalent in... design... to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively." |
| Described as placed over implant shoulder, mounted with a screw, compatible with specific Nobel Replace implant types. | ||
| Performance | Must demonstrate substantially equivalent performance to predicate device(s). | "substantially equivalent in... performance... to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace Tillnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively." |
| (No specific quantifiable performance data for this device is provided in this summary, but typically mechanical testing data would be submitted separately for such devices to demonstrate equivalency in strength or fatigue.) | ||
| Compatibility | Must be compatible with specified implant systems. | "compatible with Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants." |
| Safety Warnings/Limitations | Acknowledge and communicate known limitations or precautions. | "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 not intended for the posterior region due to limited strength of the implant." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document does not describe a clinical performance study with a distinct "test set" of patients or samples in the way an AI/software or clinical trial report would. The "study" here is a demonstration of substantial equivalence to predicate devices, likely through engineering bench testing and comparison, not patient data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth is not established in the context of this 510(k) summary. The evaluation relies on established device specifications, materials standards (ASTM), and comparison to existing cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable as there is no human adjudication of a "test set" in this type of 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
- N/A. This device is a dental implant abutment, not an AI or imaging diagnostic device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. For this type of device and submission, "ground truth" as it relates to clinical outcomes or diagnostic accuracy is not the primary focus. Instead, the "truth" against which the device is measured is its adherence to material specifications, design compatibility, and established safety/performance characteristics demonstrated by predicate devices, typically through bench testing and engineering analysis (though specific results are not detailed in this summary).
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- N/A. There is no "training set" as this is not an AI or machine learning device.
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