(400 days)
ETIII Bio-SA Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.
ETIII Bio-SA Fixture has features of single threads, internal hex connection, taper body, and Bio-SA surface treatment. ETIII Bio-SA Fixture System is permanent dental implant made with Pure titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations).
The provided text is a 510(k) summary for a dental implant system (ETIII Bio-SA Fixture System) and does not contain information about an AI/ML-driven medical device. Therefore, it does not describe acceptance criteria, a study proving an AI device meets those criteria, or other details typically associated with the evaluation of AI/ML performance.
The document discusses:
- Device Description: An endosseous dental implant system made of pure titanium, with specific design features and surface treatment.
- Intended Use: For partially or fully edentulous mandibles and maxillae to support various dental restorations.
- Predicate Devices: Comparison with existing dental implant systems, highlighting the key difference of an added hydrophilic coating for improved wettability.
- Non-Clinical Testing:
- Wettability and blood affinity observations.
- Surface analysis (EDS, FE-SEM, ICP-AES).
- Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, chromosome aberration, implantation, pyrogenicity) conducted according to ISO and FDA guidelines.
- Animal study (Beagle dogs): Measured removal torque, bone loss, and bone-to-implant contact.
- Clinical Testing: A study with 45 subjects and 66 implants, evaluating primary stability, bone resorption, complications, and other factors, reporting a 100% success rate after 16.3 months average follow-up.
- Shelf-life validation and sterilization.
Summary of missing information relevant to AI/ML device evaluation:
Since this document pertains to a physical dental implant device and not an AI/ML-driven device, it does not contain any of the requested information regarding AI/ML performance criteria or studies.
Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance.
§ 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.