(340 days)
The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The Stern IC Dental Implants are compatible with the Straumann Rn Synocta , Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, and the Straumann RC Cementable abutments. The Stern IC Dental Implant System is only intended for use with straight abutments.
The Stern IC Dental device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. This submission also includes healing abutments, solid abutments, and cover screws which are used as accessories to the dental implants. The implant components are manufactured from pure, implant-grade titanium alloy and are equivalent in terms of materials, performance specifications, manufacturing, manufacturing equipment, packaging materials and design as other Sterngold abutments and cover screws previously approved via K892124 and K924219. The Stern IC Dental Implants and abutments are compatible with the Straumann Rn Synocta (K073628), Straumann SynOcta Meso Abutments (K033243), Straumann RC Temporary Abutments, (K093027) and the Straumann RC Cementable abutments (K072071). The Stern IC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments. The proposed Stern IC Dental Implant will be available in a range of lengths and diameters.
"The provided text does not contain information about studies related to AI/ML device performance or acceptance criteria in the typical sense for such devices. The document is a 510(k) summary for a dental implant system (Stern IC Dental Implant System).
Therefore, I cannot extract the following information:
- A table of acceptance criteria and the reported device performance: This document
focuses on substantial equivalence to predicate devices, not performance criteria
against a defined benchmark. - Sample size used for the test set and the data provenance: Not applicable as
there is no discussion of a test set for an AI/ML algorithm. - Number of experts used to establish the ground truth for the test set and the
qualifications of those experts: Not applicable. - Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML device. - If a standalone (i.e. algorithm only without human-in-the-loop performance) was
done: Not applicable. - The type of ground truth used (expert consensus, pathology, outcomes data,
etc.): Not applicable. - The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Instead, the document details the substantial equivalence of the Stern IC Dental Implant
System to predicate devices based on material, design, surface treatment, and intended
use. The study described is a non-clinical testing to demonstrate appropriate
performance for the proposed indications for use, following "Guidance for Industry and
FDA Staff - Class 11 Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments."
Specifically, the non-clinical testing involved:
- SEM photographs: To show removal of all residue of the blasting material from the surface.
- Surface chemical analysis: To confirm no contaminants are left on the surface (conducted on the final device).
It states that fatigue testing was not required because design and technological features are substantially equivalent to predicate devices. The conclusion is based on an analysis of intended use, material, design, and performance being substantially equivalent to the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Straumann ITI Dental Implant System (K012757))."
§ 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.