(207 days)
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:
- 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.
- Intended Use: The device is substantially equivalent in intended use to the predicate 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.
§ 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.)