(131 days)
s-Clean SQ-SL Implant System Regular 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 Regular is composed of Fixture and Abutments. s-Clean SQ-SL Fixture is a thread type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The device has an internal connection between the implant body and the abutment component. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The implant body is the only part to be implanted into bone (mandibular or maxillary bone), and is to be connected to the abutment. Abutments are composed as below; s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Cover Screw.
The provided text describes the regulatory clearance of a dental implant system (s-Clean SQ-SL Implant System Regular) through the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish performance against specific clinical acceptance criteria.
Therefore, the document does not contain information related to acceptance criteria, a clinical study proving device performance against such criteria, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets, as these are typically part of a different type of submission (e.g., PMA or de novo) or a separate clinical validation study.
Instead, the document details non-clinical test data performed to demonstrate substantial equivalence to predicate devices.
Here's the information that can be extracted from the provided text regarding device testing:
Non-Clinical Test Data and Performance (as described in the document):
| Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|
| Bacterial Endotoxin Test (ANSI/AAMI ST72:2011, USP , USP ) | "The results of the above tests have met the criteria of the standards" |
| Shelf Life Test (ASTM F1980) | "The results of the above tests have met the criteria of the standards" |
| Sterilization Validation Test (ISO 11137-1,2,3 for subject fixtures, leveraged from K153639) | "The results of the above tests have met the criteria of the standards" |
| Sterilization Validation Test (ISO 11137-1,2,3 for subject Cover Screw, leveraged from K171027) | "The results of the above tests have met the criteria of the standards" |
| Shelf Life Test (ISO 11137-1,2,3 for subject Cover Screw, leveraged from K171027) | "The results of the above tests have met the criteria of the standards" |
| End User Sterilization Validation Test (ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 for abutments, leveraged from K171027) | "The results of the above tests have met the criteria of the standards" |
| Biocompatibility testing (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010, ISO 10993-11:2006 for fixtures, leveraged from K153639) | "The results of the above tests have met the criteria of the standards" |
| Biocompatibility testing (ISO 10993-1:2009 for machined surface abutments, leveraged from K171027) | "The results of the above tests have met the criteria of the standards" |
| Biocompatibility testing (ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006 for s-Clean TiN Coating Abutments, leveraged from K171694) | "The results of the above tests have met the criteria of the standards" |
| Biocompatibility Testing (ISO 10993-1:2009 for Cover Screw, leveraged from K171027) | "The results of the above tests have met the criteria of the standards" |
Information Not Available in the Document:
- Sample sized used for the test set and the data provenance: Not applicable as no clinical test set for performance evaluation is described. The non-clinical tests were conducted on device components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no described test set requiring expert ground truth for clinical performance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental implant system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental implant system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the non-clinical tests was the adherence to the specified international and national standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the study/evidence provided:
The submission for the s-Clean SQ-SL Implant System Regular relies on a non-clinical testing approach to demonstrate substantial equivalence to its predicate devices, as typically done for Class II medical devices through the 510(k) pathway. The study involves demonstrating that the subject device meets various established biomaterials, sterilization, and shelf-life standards (e.g., ASTM, ISO, ANSI/AAMI, USP). In many cases, the results from specific tests conducted on the predicate devices (K153639, K171027, K171694) were leveraged to support the substantial equivalence of the subject device, implying that the subject device's design, materials, and manufacturing processes are sufficiently similar to those already proven safe and effective. The document explicitly states that "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." It also notes that fatigue testing per ISO 14801 was not conducted as it was deemed unnecessary based on device-specific guidance.
§ 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.