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The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136. The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping. The fixtures' diameters and lengths are available as: Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L). Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.

The provided text is a 510(k) summary for the "S-mini active Fixture," an endosseous dental implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. This is because the device in question is a dental implant, a physical medical device, not a software or AI-based diagnostic tool.

Therefore, many of the requested points in your prompt are not applicable to the information contained within this document. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device based on material, design, sterilization, and non-clinical bench testing.

Here's how the provided information relates to your request, with an emphasis on what's not applicable:

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

The acceptance criteria for a 510(k) for a physical device like a dental implant are primarily centered around demonstrating "substantial equivalence" to a predicate device, as opposed to performance metrics like sensitivity or specificity for a diagnostic algorithm.

The document states:

• "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
• "Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance."

Acceptance Criteria (Implicit from Non-Clinical Testing):
The device must meet the criteria of the following standards and tests, demonstrating bio-compatibility, structural integrity, and durability:

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

• Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the number of physical devices tested in the non-clinical bench studies (e.g., how many implants were used for fatigue testing), which is not specified.
• Data Provenance: The tests are non-clinical, meaning they are laboratory/bench tests, not studies on human patients. The manufacture is located in South Korea.

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

• Not Applicable. This document describes a physical medical device (dental implant), not an AI or diagnostic software. Therefore, there is no "ground truth" in the diagnostic sense, nor experts interpreting images or data for a test set. The "truth" is established through engineering and biological testing against predefined standards.

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

• Not Applicable. See point 3.

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 physical device, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical device.

7. The type of ground truth used:

• Not Applicable in the context of diagnostic AI. For this physical device, "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, ANSI, USP) and the physical properties and performance characteristics demonstrated by the predicate devices. For instance, the "ground truth" for biocompatibility is defined by meeting the criteria of the ISO 10993 series.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set" and thus no "ground truth" establishment process for one.

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