(198 days)
Implants: The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: · replacing missing teeth in single or multiple unit applications in the mandible or maxilla. - · immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge - · especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective - · immediate and early loading for all indications - · together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate - · only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components Abutments ASTRA TECH Implant System™ - OsseoSpeed™ EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™ - OsseoSpeed™ EV in fully edentulous or partially edentulous maxillary and/or mandibular arches. 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 and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the 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 partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the 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. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant. ATLANTIS™ Abutment, ATLANTIS™ Crown Abutment and ATLANTIS™ Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.
The purpose of this submission is to expand the current OsseoSpeed EV Implant System (previously named OsseoSpeed Plus) to include the OsseoSpeed Profile EV implants. The OsseoSpeed EV Implant line is a part of the ASTRA TECH Implant System. The coronal contour of the OsseoSpeed Profile EV implant is designed to follow the anatomical contour of the bone and facilitate a more esthetic restoration. Implants are available in a straight (cylindrical) design or with a taper at the implant neck. Each design is provided in two diameters (4.2 and 4.8 mm) and six lengths (8, 9, 11, 13, 15, and 17 mm). Abutments are provided in titanium allov and zirconia materials. Abutments have platform diameters of 3.0, 4.2, and 4.8 mm, prosthetic diameters from 3.3 to 7.0 mm, and gingival heights ranging from 2.0 to 6.5 mm. Abutments are provided straight and with up to 30° of angulation.
The OsseoSpeed™ Profile EV is a dental implant system. The provided 510(k) summary (K130999) focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel technology or algorithm. Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they pertain to clinical or AI algorithm performance studies, which are not detailed here.
However, the document does describe the performance testing conducted to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Static and dynamic compression-bending testing according to ISO 14801 | Data included in the submission demonstrates substantial equivalence to the listed predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical testing or data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing is provided."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (dental implant mechanical performance) is established through standardized engineering tests rather than expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant to clinical studies involving expert consensus on diagnoses or outcomes, not to mechanical testing for device equivalence.
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. This device is a dental implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the performance of the predicate devices under ISO 14801 testing conditions. The subject device's performance is compared against these established benchmarks.
8. The sample size for the training set
Not applicable. This document describes a medical device seeking substantial equivalence based on mechanical performance and design principles, not an AI or machine learning model 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 this type of device submission.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.