(135 days)
The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant.
The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant.
The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.
ATLANTISTM products are compatible with the implants shown in the table below.
| Implant Manufacturer | Trade Name | Implant Diameter | Abutment Platform Diameter |
|---|---|---|---|
| Altatec GmbH | CONELOG SCREW- | ||
| LINE Implant | Ø3.3, 3.8, 4.3, 5.0 mm | Ø3.3, 3.8, 4.3, 5.0 mm |
The proposed ATLANTIS™ Abutment for CONELOG implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (Ø3.3, 3.8, 4.3 and 5.0 mm) and three designs: ATLANTIS™ Abutment for CONELOG implant, ATLANTIS™ Crown Abutment for CONELOG implant and ATLANTIS™ Conus Abutment for CONELOG implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screwretained, cement-retained or friction fit prosthesis.
The coronal portion of the ATLANTIS™ Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTIS™ Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS™ Crown Abutment). The ATLANTIS™ abutment interface is compatible with the CONELOG implants from the CONELOG Implant System (K113779).
The CONELOG implant interface is an internal connection with indexing feature (three grooves) and provided for implant platform diameter (3.3, 3.8, 4.3 and 5.0 mm). The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.
The provided text describes a 510(k) premarket notification for the "ATLANTIS™ Abutment for CONELOG implant," a dental implant abutment. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. While the document details the device, its intended use, and comparisons to predicate devices, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format typically used for AI/ML medical devices.
Instead, the provided text focuses on:
- Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing intended use, technological characteristics, and performance data.
- Non-Clinical Performance Data: The document mentions "mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801." These are standard engineering tests for dental implants to demonstrate structural integrity and durability.
- Biocompatibility and Sterility: These aspects are addressed by referencing prior testing conducted for a primary predicate device, stating that the materials and sterilization processes are the same.
Therefore, I cannot populate the table or answer the specific questions below as they pertain to acceptance criteria, clinical study design, ground truth establishment, or human-in-the-loop performance, which are not detailed in this regulatory submission for a physical implant component.
Here's a breakdown of why I cannot answer each point based solely on the provided text:
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A table of acceptance criteria and the reported device performance: The document mentions "mechanical testing results show that the ATLANTIS™ Abutment for CONELOG implant has sufficient strength for its intended use" and "compatibility analysis shows that the ATLANTIS™ Abutment for CONELOG implant is compatible with the (3.3, 3.8, 4.3 and 5.0 mm) CONELOG implants." However, it does not state specific quantitative acceptance criteria (e.g., "must withstand X N of force") nor detailed numerical reported device performance in a table. It refers to ISO 14801, which outlines testing methodologies but not necessarily specific pass/fail values that would be reported in this summary.
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Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components for mechanical testing, not a dataset of patient images or clinical data. No details on the number of physical samples tested are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical evaluation or ground truth for AI/ML models, which is not the subject of this submission. The "ground truth" for mechanical properties would be derived from physical measurements and engineering standards, not expert clinical consensus.
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Adjudication method: Not applicable. This is for clinical or AI model evaluation.
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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. This device is a physical dental abutment, not an AI/ML algorithm for image interpretation or diagnosis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used: For mechanical testing, the "ground truth" would be the predefined engineering specifications (e.g., material strength requirements, dimensional tolerances) and the observed performance of the tested physical components against these specifications. The document implies compliance with ISO 14801.
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The sample size for the training set: Not applicable. This is for AI/ML models, not a physical device.
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How the ground truth for the training set was established: Not applicable. This is for AI/ML models.
In summary, the provided document is a regulatory submission for a physical medical device (dental abutment) and outlines its demonstration of substantial equivalence through non-clinical mechanical testing, biocompatibility, and sterility, rather than clinical efficacy studies with human subjects or AI/ML model performance 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.)