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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.

This submission is to add new implants to the previously cleared device, s-Clean SQ-SL Implant System Regular (K192688). The newly added implant is "s-Clean SQ-SL Fixture with Ø5.2mm diameter".

The s-Clean SQ-SL Implant System Regular is composed of a fixture and cover screw. The s-Clean SQ-SL Fixture is a thread-type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which is placed in the alveolar bone to replace the function of the missing tooth. This device has a connection between the upper prosthesis and the internal Hex.

The Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is the only part to be implanted into bone, to provide connection of prosthetic devices or other components of a dental implant set within the human body (mandibular or maxillary bone).

The document details a 510(k) premarket notification for the "s-Clean SQ-SL Implant System Regular" and relies on substantial equivalence to a predicate device (K192688) rather than presenting new clinical study data with acceptance criteria that would typically be associated with AI/ML device performance.

Therefore, the requested information elements related to AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, and training set details, are not applicable to this submission.

The acceptance criteria provided in the document pertain to the physical and material characteristics, manufacturing processes, and sterilization validation of the dental implant, demonstrating its equivalence to the predicate device.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable. The submission leverages non-clinical test data from predicate devices (K192688 and K153639). No new clinical test set was used for the subject device to establish new performance metrics. The data provenance is implied to be from internal testing conducted by Dentis Co., Ltd. for the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No new clinical test set requiring expert ground truth was performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No new clinical test set requiring adjudication was performed for this 510(k) submission.

5. 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, not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a dental implant, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. The "ground truth" here refers to the compliance with established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for medical device materials, manufacturing, and sterilization, as demonstrated by the predicate devices.

8. The sample size for the training set:

• Not Applicable. This device is a dental implant, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. This device is a dental implant, not an AI/ML device.

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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):

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.

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