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The Dentis s-Clean Abutment Mini is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Dentis s-Clean Abutment Mini is composed of Abutments are made of Ti-6AI-4V ELI according to ASTM F136 and Cobalt-28Chromium-6Molybdenum Alloy ASTM F1537. The s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment is screw assembled design but s-Clean CCM UCLA Abutment s-Line is screw separation design. The s-Clean TiN Half Coating Sub-Octa Abutment is always to be combined with a casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading. The minimum post height of s-Clean TiN Half Coating Sub-Octa Abutment when combined with casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading is 4mm. The minimum post height of s-Clean CCM UCLA Abutment s-Line for single-unit loading is 4mm. The Subject device is compatible with implants cleared in K210080. Compatible fixture diameters are Ø5.8. 6.8 and Ø7.8 and lengths are 7.5. 9.5, 11.4 and 11.5mm. Compatible fixture, K210080, has dual screw-joint (structured with Upper and Lower screw joint) and a hex anti-rotation design connection. As explained in K210080, there are two-screw-joint features, 1.6M screw (Lower part) or 2.0M Screw (Upper Part) for diverse screw connection with other abutments. s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment have Upper M2.0 Screw and s-Clean CCM UCLA Abutment s-Line has Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated twopiece abutment is connected with lower screw.

The Dentis s-Clean Abutment Mini is an endosseous dental implant system, and the provided document is a 510(k) summary for its FDA clearance. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a standalone study with specific acceptance criteria and performance data for the subject device itself. Therefore, much of the requested information regarding acceptance criteria, performance data, sample sizes, expert ground truth, and specific study types (MRMC, standalone) as typically described for AI/ML device evaluations is not applicable or available in this kind of regulatory submission.

Instead, the document asserts substantial equivalence based on:

1. Similarities in intended use, materials, and product specifications with predicate devices.
2. Leveraging non-clinical testing data from predicate devices for biocompatibility and sterilization, as the materials and manufacturing processes are considered equivalent.
3. Scientific rationale and literature review for MRI safety, rather than new testing.

Here's a breakdown of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the context of specific performance metrics for the Dentis s-Clean Abutment Mini against defined acceptance criteria. The regulatory approval is based on demonstrating that the device is substantially equivalent to predicate devices already on the market, implying that it meets the accepted safety and effectiveness standards without necessarily requiring new, specific performance studies for this particular submission.

The document highlights the following characteristics of the subject devices (Dentis s-Clean Abutment Mini: s-Clean O-Ring Abutment s-Line, s-Clean TiN Half Coating Sub-Octa Abutment, and s-Clean CCM UCLA Abutment s-Line) and compares them to predicate devices:

2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a new clinical or non-clinical test set specifically for the Dentis s-Clean Abutment Mini for performance evaluation against acceptance criteria. The approach relies on substantial equivalence to predicate devices and leveraging existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No specific "test set" with expert-established ground truth is described for this submission, as it focuses on demonstrating equivalence rather than proving new performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. As there's no defined test set for performance, adjudication methods are not relevant here.

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 physical dental implant abutment, not an AI/ML diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No new ground truth data was established for performance evaluation of the subject device in this submission. The "ground truth" for the clearance is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

Summary of the Study (Compliance with Standards and Leveraged Data):

The "study" described in this 510(k) submission is primarily a non-clinical review and comparison to predicate devices, leveraging previously established data and scientific rationale.

• Biocompatibility Testing: Performed for predicate devices and "leveraged for the subject device" because the materials (Ti-6Al-4V ELI and Cobalt-28Chromium-6Molybdenum Alloy) and manufacturing processes are substantially equivalent. Tests were conducted according to ISO 10993-1:2009.
• End User Sterilization Validation Test Report: Performed for predicate devices (K210080 for Ti-6Al-4V, K161244 for Cobalt-28Chrominum-6Molybdenum, and K171027 for Ti-6Al-4V with TiN Coating) and "leveraged for the subject device." Tests were conducted according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1. The report also mentions a test article for Cobalt-27Chrominum-6Molybdenum that was the "largest surface area among the devices that have the same manufacturing process and material," likely representing a worst-case scenario.
• Fatigue Testing: Not performed for the subject device itself, as it does not include angled abutments. This decision is based on FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," which states fatigue testing is not necessary for systems without angled abutments.
• Surface Modification Information: Not tested or provided for the subject device because it was "provided in the predicate devices and can be leveraged for the subject device," implying similar surface characteristics.
• MR Environment Condition: A non-clinical worst-case MRI review was performed. This involved evaluating the device's components (materials) against scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to assess magnetically induced displacement force and torque. The FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" was referenced.
• Clinical Testing: This was explicitly stated as "not necessary to establish substantial equivalency of the device."

In conclusion, this regulatory submission focuses on demonstrating substantial equivalence through a rigorous comparison of the subject device's features (materials, dimensions, intended use, sterilization, surface treatment) to already-cleared predicate devices, coupled with leveraging existing non-clinical test data and scientific literature for safety aspects. It is not a performance study in the sense of establishing new acceptance criteria and demonstrating achievement through new testing specific to the subject device alone.

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