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The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The s-Clean OneQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal double hexagonal connection, intended for single use. The s-Clean OneQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

This system consists of the fixture, cover screw, various abutments and prostheses. Only the subject abutments can be used with the subject fixtures.

This document describes the regulatory submission for the s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd. The document is primarily a 510(k) summary demonstrating substantial equivalence to predicate devices, rather than a standalone study documenting acceptance criteria and performance. Therefore, detailed information on acceptance criteria and specific study results proving the device meets those criteria, particularly for clinical outcomes, is limited.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantified performance targets and corresponding device performance for direct comparison in the way a clinical study report would. Instead, it relies on non-clinical testing against recognized standards to demonstrate equivalence.

The "acceptance criteria" are implied by adherence to these standards and the demonstration of "substantial equivalence" to predicate devices. The "reported device performance" is essentially that the device met the criteria of these standards and demonstrated substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of human clinical data. All reported tests are non-clinical (biocompatibility, fatigue, endotoxin, sterilization, shelf life, surface characterization).

For non-clinical tests, sample sizes would typically be determined by the specific standards (e.g., ISO 14801 for fatigue testing might specify a minimum number of samples). The document states the tests were performed "for predicate devices and leveraged for the subject device" or "for the subject device." No specific sample numbers for these non-clinical tests are provided.

The "data provenance" for non-clinical tests is from the manufacturer's own testing (Dentis Co., Ltd.) or testing supporting their predicate devices. There is no mention of country of origin for non-clinical test data, but the manufacturer is based in South Korea.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a non-clinical submission demonstrating substantial equivalence through engineering and material testing, not human clinical trials requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable for a non-clinical 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 system, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed or is relevant.

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

Not applicable. This is a physical medical device (dental implant system), not an algorithm or software. Its performance is evaluated through material and mechanical testing, not algorithm performance.

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

For the non-clinical tests, the "ground truth" is established by the specifications and pass/fail criteria defined in the referenced international standards (e.g., ISO 10993, ISO 14801, USP ), and by demonstrating material/design equivalence to legally marketed predicate devices. There is no biological "ground truth" from pathology or outcomes data generated by this submission directly for the subject device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no "training set" for this device.

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