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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.

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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, 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 Implant System Mini 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.

Fixture's surface 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 s-Clean SQ-SL Implant System Mini Abutments are composed as below;

s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Mini Fixture Cover Screw

s-Clean SQ-SL Fixture and s-Clean Mini Fixture Cover Screw are provided sterilized. And the other Abutments are provided non-sterilized.

s-Clean SO-SL Fixture is enclosed with s-Clean Mini Fixture Cover Screw in a set packing. s-Clean Mini Fixture Cover Screw is also provided separately.

Based on the provided text, the document is a 510(k) Premarket Notification from Dentis Co., Ltd. for their s-Clean SQ-SL Implant System Mini. This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

The document discusses the design, materials, and intended use of the dental implant system and compares it to predicate devices. However, the provided text does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or human reader improvement with AI assistance.

The "Non-Clinical Test Data" section lists various tests performed on the predicate devices and leveraged for the subject device to demonstrate substantial equivalence, specifically regarding sterilization, shelf life, biocompatibility, and bacterial endotoxin. These are safety and manufacturing standard compliance tests, not performance studies as typically understood for AI/diagnostic devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the manner you've outlined for AI or diagnostic devices, as this information is not present in the provided FDA 510(k) summary. The document focuses on demonstrating substantial equivalence to similar dental implants based on material, design, and manufacturing standards, rather than clinical performance outcomes or AI accuracy.

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