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The Atlantis Abutment is intended for use as an accessory to an osseous 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 osseous implant.

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 the 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 Zimmer 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 Zimmer Screw-Vent MTX and HA implants with diameters 3.3 mm, 3.7 mm, 4.7 mm; Zimmer Tapered Screw-Vent MTX and MP-1 HA implants with diameters 3.7 mm, 4.7 mm and 6.0 mm.

The provided document, K053373, describes a pre-market notification for the Atlantis™ Abutment for Zimmer Interface. This is a medical device submission seeking substantial equivalence to a predicate device, rather than a study demonstrating performance against specific acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for AI-driven devices is not applicable to this submission.

Here's a breakdown of what can be extracted from the document in relation to the questions, and where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is typically used for novel devices that undergo performance testing against pre-defined metrics (e.g., sensitivity, specificity, accuracy for AI/diagnostic devices). For a medical device submission seeking substantial equivalence, the "acceptance criteria" are primarily related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is assessed against the predicate device's established use and material properties, not against quantitative performance metrics in a clinical study.

Therefore, a direct table of acceptance criteria and reported device performance as typically understood for AI systems cannot be provided from this document. The "performance" is implicitly deemed acceptable if it is substantially equivalent to the predicate.

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

Not applicable. This submission is for a dental implant abutment, not an AI or diagnostic device that would utilize a test set of data for performance evaluation. The "test set" in this context would implicitly refer to the abutment itself and its components.

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

Not applicable. Ground truth establishment by experts is relevant for diagnostic or AI systems where expert annotations or interpretations serve as the reference standard. For a physical medical device like a dental abutment, "ground truth" relates to its physical and material properties, and its intended use, which are evaluated against engineering standards and clinical practice, not expert consensus on data interpretation.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as points 2 and 3. Adjudication methods like "2+1" or "3+1" are used in consensus-based ground truth establishment for diagnostic data.

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

Not applicable. An MRMC study is designed to evaluate the impact of a diagnostic aid (often AI) on human reader performance. This submission is for a physical dental abutment, which does not involve human "readers" in the context of diagnostic interpretation.

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

Not applicable. This refers to the performance of an AI algorithm independently. The Atlantis Abutment is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is its adherence to material standards (Titanium grade Ti-6A1-4V ELI meets ASTM Standard F-136) and its intended use being equivalent to predicate devices. Equivalence is also drawn from the design and performance to the predicate Atlantis Abutments (K981858) and Sulzer Dental (Zimmer) Screw-Vent Implant Systems (K011028). The FDA's substantial equivalence determination implies that the device's characteristics meet established clinical and engineering benchmarks for this class of device.

8. The Sample Size for the Training Set

Not applicable. A "training set" is used for machine learning models. This is a physical product submission.

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

Not applicable for the same reasons as point 8.

Summary of Relevant Information from the Document:

While the document does not fit the typical structure of an AI device study, here's a summary of the information relevant to its acceptance and equivalency:

• Device Name: Atlantis™ Abutment for Zimmer Interface
• Manufacturer: Atlantis Components Inc.
• Predicate Devices:
  • Atlantis Abutment and Abutment Screw (K981858, K011028) by Atlantis Components Inc.
  • Screw-Vent Implant System by Sulzer Dental (Zimmer)
• Basis for Substantial Equivalence (Acceptance Criteria Implicit):
  • Intended Use: The device is substantially equivalent in intended use to the predicate devices.
    • Intended Use Description: As an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient, for single and multiple tooth prosthesis, in the mandible or maxilla. Prosthesis can be cement retained. Abutment screw secures the abutment to the implant.
  • Material: Made from Titanium grade Ti-6A1-4V ELI, meeting ASTM Standard F-136, which is consistent with predicate devices.
  • Design: Equivalent to predicate devices. The abutment is placed over the implant shoulder and mounted with a screw. Compatible with specific Zimmer Screw-Vent MTX and HA implants of various diameters.
  • Performance: Implied to be equivalent through substantial equivalence claims. Performance would relate to mechanical integrity and fit, which are assumed to be met given the material and design equivalence to previously cleared devices.

Conclusion:

This document is a 510(k) pre-market notification for a traditional medical device (dental abutment). The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of intended use, materials, design, and performance, as required by the FDA's 510(k) pathway. It does not involve a study with primary performance endpoints suitable for the detailed questions about AI device evaluation.

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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.

This device is compatible with the following manufacturers' implant systems: Zimmer Dental, Nobel Biocare, 3i, Lifecore, Sterngold, Implamed, Innova and BioHorizons.

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.

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).

This submission focuses on a dental implant abutment, specifically the Atlantis™ Abutment in Zirconia, and its substantial equivalence to previously marketed devices. The document does not describe a study involving a device with acceptance criteria and reported device performance in the context of an AI/software device. Instead, it is a 510(k) pre-market notification for a physical medical device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. The document is for a physical dental device, not a software or AI-driven diagnostic or treatment device.

However, I can extract the relevant information about the device itself and its deemed equivalence:

Device Description and Equivalence:

• Device Name: Atlantis™ Abutment in Zirconia (Trade Name), Endosseous dental implant abutment (Common Name and Classification Name).
• Intended Use: To be placed into a dental implant to provide support for a prosthetic reconstruction in a partially or completely edentulous patient. It supports single and multiple tooth prostheses in the mandible or maxilla, with the prosthesis cement-retained to the abutment. The abutment screw secures the abutment to the endosseous implant.
• Material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) for the abutment (Meets ISO standards 6872 & 13356), and Titanium grade Ti-6A1-4V ELI for the abutment screw (Meets ASTM Standard F-136).
• Predicate Devices:
  • Zimmer Dental, Screw Vent Implant System (K011028)
  • Atlantis Components Inc., Atlantis Abutment in Zirconia (K052070)
• Basis for Substantial Equivalence: The Atlantis™ Abutment in Zirconia is considered substantially equivalent in intended use, material, design, and performance to the listed predicate devices.
• Compatibility: This device is compatible with implant systems from Zimmer Dental, Nobel Biocare, 3i, Lifecore, Sterngold, Implamed, Innova, and BioHorizons.

Regarding the specific questions, and why they are not applicable here:

1. A table of acceptance criteria and the reported device performance: This document is a 510(k) summary for substantial equivalence, not a performance study report for an AI or diagnostic device. There are no "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, AUC) for a physical abutment in this context. The acceptance is based on meeting the defined "Intended Use" and demonstrating equivalence in "material, design and performance" to predicate devices, which is generally done through mechanical testing and material characterization, not clinical performance metrics presented in a table like this.
2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" of data as would be used for an AI/software device.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as understood in AI/software evaluation (e.g., expert labels for images) is not relevant for a physical dental abutment’s 510(k) submission.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. MRMC studies are for evaluating diagnostic accuracy, not for a physical implant component.
6. If a standalone performance was done: Not applicable in the context of AI. The "performance" assessment for this physical device would involve things like fatigue testing, biocompatibility, and fit, which are demonstrated to be equivalent to predicates rather than a standalone performance metric reported here.
7. The type of ground truth used: Not applicable. For a physical device like this, the "ground truth" for regulatory clearance is that it meets engineering specifications and is equivalent to previously cleared devices.
8. The sample size for the training set: Not applicable. No "training set" for a physical device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory submission for a physical dental implant component, not a software or AI-driven device. Therefore, the questions designed to probe the evaluation of an AI-driven device are largely not relevant to this document.

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