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The IS-III active System 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 internediate Abutment support for fixed bridgework. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

IS-III active System is composed of IS-III active fixtures and Abutments. IS-III active Fixture is a thread type implant made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with 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). There are 4 types of fixtures in this system and the dimensions are as following: Tolerance of dimension shall be within ± 1% range. IS-III active System Abutments are composed of IS Cover Screw, IS Healing Abutment, IS Encoded Healing Abutment, IS Solid Abutment, Protective Cap, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Gold UCLA Abutment, IS Temporary Abutment, IS Ball Abutment, IS Ball Abutment Component (Housing, Retainer, O-ring) and IS Abutment Screw. The dimensions of abutments are as following: Tolerance of dimension for Abutments shall be within ± 1% range. The purpose of Anodizing for Cover Screw is to distinguish the sizes with the naked eyes for convenience. The surface of IS Solid, cemented, Shapable, Angled Abutments was treated with TiN-Coated. IS-III active Fixture, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized. IS-III active Fixture is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing. The Solid Abutment is enclosed with Protective cap. All of above products including enclosed product are packed separately for convenience.

The provided document is a 510(k) Premarket Notification for a dental implant system. It outlines the characteristics of the IS-III active System and compares it to predicate devices to demonstrate substantial equivalence, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for an AI/ML powered device.

Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not present in this document.

However, I can extract information related to the device's non-clinical testing and comparison to acceptance criteria (standards).

Here's the closest representation of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study for the Neobiotech IS-III active System (K181138)

This 510(k) submission establishes the substantial equivalence of the IS-III active System to legally marketed predicate devices primarily through comparison of technological characteristics and non-clinical performance testing against recognized standards. The acceptance criteria are derived from these international and internal standards, and the device's performance data is reported as meeting these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Specific sample sizes for each non-clinical test (e.g., number of implants for fatigue testing or biocompatibility animal models) are not detailed in this summary document.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data nor if it was retrospective or prospective, as these are typically not relevant for non-clinical bench or lab testing. The testing was conducted to international and US FDA recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical engineering and biological tests conducted against established standards, not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context.

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

This information is not applicable as the document describes non-clinical engineering and biological tests.

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

This information is not applicable. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.

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

This information is not applicable. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.

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

For biocompatibility and mechanical testing, the "ground truth" is defined by the established criteria and methodologies within the cited international ISO and ASTM standards, as well as the FDA guidance document. For example, for fatigue, the "ground truth" is that the device must withstand a certain number of cycles at a specified load without failure, as per ISO 14801.

8. The sample size for the training set

This information is not applicable. This document is for a physical medical device. There is no AI/ML algorithm or "training set" involved in its development or evaluation as described here.

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

This information is not applicable. No training set is mentioned or relevant to the information provided in this 510(k) summary for a physical dental implant.

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