(171 days)
The HT III 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 HT III SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.
- The HTⅢ SA Fixture System is dental implant made of titanium metal intended to The 111m of I hitalie byelom of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
- HTⅢ SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has SA surface.
- The HTII SA Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The provided text is a 510(k) summary for a dental implant system (HTIII SA Fixture System) seeking substantial equivalence to existing predicate devices. It does not describe any acceptance criteria or a study proving device performance against such criteria in the context of an AI/human comparative effectiveness study or a standalone algorithm performance study.
Instead, this document focuses on demonstrating substantial equivalence through comparisons of:
- Intended Use: The HTIII SA Fixture System is used in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and for single and two-stage surgical procedures (not for immediate load). This is directly compared to the predicate HGIII Fixture System, which has identical intended use, and generally aligns with the Straumann Standard Implant.
- Design and Technology: It highlights features like single threads, taper body type, self-tapping, submerged fixture, and internal hex connection, stating it's similar to the predicate HGIII Fixture System.
- Material: The device is made of Pure Titanium Grade 4 (ASTM F67-06), identical to both predicate devices.
- Surface Treatment: While the HTIII SA Fixture uses "SA" surface treatment, the predicate HGIII uses "RBM", and the Straumann Standard Implant uses "SLA". The document states the HTIII SA Fixture's surface treatment is "similar" to the Straumann Standard Implant.
- Biocompatibility and Safety: Biocompatibility tests were conducted according to ISO 10993 standards (ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, and ISO 10993-11), and surface treatment tests were performed. The results were found to be similar to previously cleared predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or AI study details because this document pertains to a medical device (dental implant) and its regulatory clearance process, not an AI or diagnostic imaging device involving performance metrics like sensitivity, specificity, or reader studies.
The "study" referenced in this document is a series of non-clinical tests (biocompatibility and surface treatment) demonstrating the device's safety and performance characteristics are similar to predicate devices, thereby supporting its substantial equivalence for regulatory clearance.
§ 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.