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The DioSlimon Implant System is intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

DioSlimon Implant System consists of Dental Implants, Superstructure, Instruments of Prosthetic and Surgical Instruments. The Dental Implant of the DioSlimon Implant System is an integrated system of endosseous dental implant which designed to protect main implant from immediate loading during osteointegration period; to increase indurance of temporary tooth and to the immediate functions and immediate recovery of aesthetics of conduct osteoimplanted area. These are made of Titanium Alloy(Ti-6AI-4V ELI / ASTM F136) which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implant which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length(8/10/12/14mm). The superstructure consists of Ball Cap intended to retain the O-ring inside of the denture. The Instruments of Prosthetic and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The Dental Implant is gamma sterilized and intended to single use. And the others are non-gamma sterilized. It have to be sterilized by user before using.

The provided text describes a 510(k) submission for the DioSlimon Implant System, which is a dental implant device. It is a Special 510(k), indicating a modification to a previously cleared device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not available in the provided text. The submission primarily relies on comparing the technical characteristics and intended use of the new device to a predicate device.

Here's a breakdown of what can be extracted from the provided text regarding acceptance criteria and the "study" (which in this case refers to the non-clinical testing performed for substantial equivalence):

1. Table of Acceptance Criteria and Reported Device Performance

Instead of formal "acceptance criteria" and detailed "reported device performance" in a clinical trial sense, the device demonstrates equivalence through a comparison of physical characteristics and intended use, and conformance to design input requirements through laboratory testing.

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of clinical data. The "testing" primarily involved laboratory testing of the device itself.
• Data Provenance: The submission is from DIO Corporation, based in Korea. The "study" mentioned is laboratory testing, so the data is internally generated by the manufacturer. The nature of the submission (Special 510(k) based on substantial equivalence) indicates it's likely a review of existing technical data and possibly new bench testing, not a new clinical trial.

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

• Not Applicable. This type of information is typically relevant for studies involving subjective human assessment (e.g., image interpretation). For a dental implant device demonstrating substantial equivalence through technical specifications and bench testing, expert consensus on a "ground truth" for a test set is not generally relevant or described in the provided document. The ground truth for substantial equivalence is the established characteristics and safety/effectiveness of the predicate device.

4. Adjudication method for the test set:

• Not Applicable. As no clinical "test set" requiring expert judgment is mentioned, no adjudication method would have been used.

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 is a dental implant device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related effectiveness metrics are not relevant or described.

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), not an algorithm or software.

7. The type of ground truth used:

• The "ground truth" in the context of a 510(k) substantial equivalence submission for a device like this is the established safety and effectiveness of the identified predicate device (DIO Protem Implant System (2.0/2.5mm), K080126) and conformance to recognized standards and design requirements through laboratory testing. There isn't "ground truth" derived from clinical outcomes or pathology in the same way one would for a diagnostic device.

8. The sample size for the training set:

• Not Applicable. As this is a physical medical device and not an AI or diagnostic algorithm, there is no "training set."

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

• Not Applicable. See point 8.

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