(223 days)
iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
The iSy Implant System is an endosseous dental implant system designed for ease of use. Each product package contains the components needed for implant placement, impression taking, gingival contouring, and temporization. Components available with the iSy Implant System include the implant base, cover cap, multifunctional cap, gingiva former, universal abutment and Titanium base CAD/CAM. The implants are provided in three diameters (3.8, 4.4 and 5.0 mm) and three lengths (9, 11, and 13 mm). The implant/abutment interface is identical for all sizes and, therefore, only one abutment connection is necessary. The implant base is a mount, supplied with the implant, that also can be used for temporary restoration. Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°. The cover cap, multifunctional cap and gingiva former are temporary abutments used during healing. The universal abutment and titanium base CAD/CAM are abutments used for final restoration. The iSy implants are made of unalloyed titanium, iSy implant base, universal abutment and Titanium base CAD/CAM are made of titanium alloy, and iSy cover cap, multifunctional cap and gingiva former are made of polyetheretherketone.
The provided document is a 510(k) premarket notification for the Altatec GmbH iSy® Implant System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
However, the document does not contain information related to acceptance criteria, device performance, ground truth establishment, sample sizes for test/training sets, adjudication methods, or MRMC studies for an AI/ML powered medical device. The device described is an endosseous dental implant system, which is a physical medical device, not a software or AI/ML product.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document refers only to non-clinical testing data such as engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801. It explicitly states: "Clinical data were not submitted in this premarket notification."
§ 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.