(201 days)
The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System II is consists of dental fixtures, screws and multiunit abutment cylinders.
The provided document is a 510(k) summary for the IBS Implant System II, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical testing. It does not describe an acceptance criteria study with the requested details (number of experts, sample size for test/training set, ground truth methods, MRMC study, or standalone performance).
Instead, the document details a comparison of the new device to existing devices (predicates) regarding various technical specifications and non-clinical test results.
Since the document does not contain the information for acceptance criteria and a study proving device meets it as requested, I cannot complete the table or answer the specific questions.
No information for the requested table and study details is available in the provided text. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests (biocompatibility, endotoxin, sterilization validation, shelf-life validation, fatigue). These are not presented as a study with specific acceptance criteria that the device performed against in the way an AI/software performance study would be evaluated.
Therefore, the requested table of acceptance criteria and reported device performance cannot be generated. Similarly, specific details about sample size (training/test), data provenance, expert involvement, adjudication, MRMC, or standalone performance are not provided as these types of studies are typically associated with performance claims for diagnostic or prognostic devices, not for substantial equivalence of an endosseous dental implant based on physical and material properties.
§ 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.