(617 days)
The INNO SLA Submerged Implant 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 INNO SLA Submerged Implant System offers Healing Abutment (Type A and Type B), Angulated Abutment, Temporary Abutment, Sonator S Abutment, Sonator A Abutment, and Screws. These components are used with the fixtures and cover screws cleared under K132242.
The provided text is a 510(k) summary for the INNO SLA Submerged 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 the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML-driven device performance study. The device described, the "INNO SLA Submerged Implant System," is a physical dental implant system and not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.
The document does mention "Non-Clinical Testing" which includes:
- Surface Modification: Leveraging specifications and processes from a predicate device (K132242) for TiN coating.
- Cytotoxicity Testing: Performed on representative abutments with TiN coating according to ANSI/AAMI/ISO 10993-5 and ISO 10993-12. This type of testing ensures the material is not harmful to cells.
- Mechanical performance testing: Conducted according to ISO 14801. This test establishes the fatigue limit to ensure structural integrity and sufficient strength for intended use. The "worst-case scenario" was chosen based on FDA Guidance.
- End-user sterility validation: Conducted according to ISO 17665-1 and ISO 17665-2 for a prior clearance (K132242) and leveraged for the subject devices.
These tests are standard for physical medical devices and confirm material compatibility, mechanical robustness, and effective sterilization, which are relevant "acceptance criteria" for such devices. The document explicitly states that the mechanical performance test demonstrated "sufficient strength for their intended use and are substantially equivalent to predicate devices with regard to mechanical performance."
In summary, the requested information regarding AI/ML device performance cannot be extracted from this document because it pertains to a physical dental implant system, not an AI/ML system.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)