(178 days)
s-Clean SQ-SL Implant System Mini 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
s-Clean SQ-SL Implant System Mini is composed of Fixture and Abutments. s-Clean SQ-SL Mini Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The s-Clean SO-SL Implant System Mini Abutments are composed of s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Mini Fixture Cover Screw. The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-ioint feature is for diverse screw connection for 1.6M or 2.0M sizes. The implant bodies are only compatible with subject abutments of S-Clean Sole Abutment s-Line and s-Clean TiN Half Coating Sole Abutment s-Line with 2.0M screw. These abutments are connected with only upper screw of the implant body. The 1.6M size allows the implant to be compatible with potential future cleared abutments. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
The provided text describes a 510(k) premarket notification for a dental implant system (s-Clean SQ-SL Implant System Mini) and its substantial equivalence to predicate devices. It does not contain information about an AI/ML-driven device, nor does it present acceptance criteria or a study proving the device meets those criteria in the context of an algorithmic performance study.
The document primarily focuses on demonstrating the substantial equivalence of a physical medical device (dental implants) through comparison of technological characteristics, materials, and non-clinical engineering test data (e.g., sterilization, biocompatibility, fatigue testing) against legally marketed predicate devices.
Therefore, I cannot extract the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies from the provided text. The document is about a hardware dental implant system, not a software or AI/ML product.
§ 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.