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The IT-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, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium 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 Octa. 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). The IT -III active System Abutment are composed as below; IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw.

The provided text describes the Neobiotech Co., Ltd. IT-III active System, an endosseous dental implant system, and its substantial equivalence to predicate devices, but does not contain a study comparing the device's performance against specific acceptance criteria and reporting its performance metrics in a way that directly answers all the questions in the prompt.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to already legally marketed devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the format requested.

However, I can extract the information provided that is relevant, or indicate where the information is not present.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the requested format. Instead, it states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device did meet the criteria of the standards listed, but doesn't quantify the performance against those criteria.

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

The document lists non-clinical testing performed, such as Fatigue Testing, Sterilization Testing, Shelf Life Testing, Bacterial Endotoxin Test, and Biocompatibility Evaluation. However, it does not specify the sample sizes used for these tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 type of information is not applicable to the non-clinical testing (fatigue, sterility, etc.) described in the document. Ground truth as typically established by experts (e.g., radiologists for imaging studies) is not relevant for the engineering and biological tests conducted for dental implant device clearance.

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

This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, which is not the nature of the tests performed 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

No MRMC comparative effectiveness study was performed or mentioned in this document. This study type is far more common for diagnostic imaging AI devices, rather than for a dental implant system.

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

This concept is not applicable to the IT-III active System, which is a physical dental implant. Standalone algorithm performance refers to the performance of AI software independent of human intervention, which is not relevant for this device.

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

For the non-clinical tests conducted, the "ground truth" is defined by the standards themselves (e.g., ISO 14801 specifies the methodology and interpretation for fatigue failure, ISO 11137 for sterility). The tests measure whether the device meets the predefined physical, mechanical, and biological properties as stipulated by these recognized standards. It's not about an expert diagnosis or clinical outcome but rather adherence to engineering/material specifications.

8. The sample size for the training set

No training set is mentioned or applicable. This document is not describing a machine learning or AI algorithm, but rather a physical dental implant device undergoing non-clinical validation.

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

Not applicable, as there is no training set described.

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