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The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only

This product is orthodontic screw used for straightening of irregular teeth. It is designed for indications such as malocclusion treatment, straightening of irregular teeth, improvement of intermaxillary space and occlusion, and maintenance after orthodontic treatment.
It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily and is removed after orthodontic treatment has been completed.
Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures.
The Orthodontic Screw is a dental device made of titanium alloy metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
It is 1.2, 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length.
It is made of Titanium alloy (Ti-6Al-4V ELI).
There are two types of surface treatment one is non-treated (Machineed) another one is Acid etching

The provided text describes the regulatory submission for an Orthodontic Screw, which is a medical device, and includes a summary of nonclinical testing. It does not contain information about acceptance criteria for AI/ML performance, nor does it describe a study involving an AI device or human readers. Therefore, I cannot fulfill the request as it pertains to AI/ML device performance.

However, I can extract information regarding the nonclinical testing performed for this Orthodontic Screw:

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

The document mentions three types of performance tests conducted. It states "We conducted performance test due to addition of smaller diameter Ø1.2mm Fracture load Test, Rotational fracture torque test, Axial pull-out strength test." However, the specific acceptance criteria (e.g., minimum fracture load, torque, or pull-out strength) and the reported device performance values are not provided in the document. The document only lists the types of tests performed.

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

The document does not provide details on the sample size used for these performance tests, nor the data provenance (country of origin, retrospective/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 information is not applicable as the tests described are mechanical performance tests of a physical device, not an AI/ML system requiring expert ground truth for imaging or diagnostic tasks.

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

Not applicable for mechanical performance 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:

Not applicable. This is a physical medical device, not an AI system that assists human readers.

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

Not applicable. This is a physical medical device.

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

For the three performance tests (Fracture load Test, Rotational fracture torque test, Axial pull-out strength test), the "ground truth" would be the experimentally measured physical properties of the Orthodontic Screw under specific load conditions. These measurements are typically derived from standardized testing procedures, not from expert consensus, pathology, or outcomes data in the context of device performance claims.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML system.

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

Not applicable. This is a physical device.

Additional Information from the Document:

• Biocompatibility: Demonstrated by reference to K122171.
• Sterilization Validation: Demonstrated by reference to K072896 (gamma irradiation process).
• Surface Treatment Characterization: Demonstrated by reference to K122171.
• Clinical Studies: "No clinical studies are submitted."
• Substantial Equivalence: The claim of substantial equivalence is based on the device having the same principles of operation, material (Titanium alloy Ti-6Al-4V ELI, ASTM F 136), indication for use, and similar design to predicate devices. The performance tests were conducted due to the addition of a smaller diameter (Ø1.2mm) and new head types (Small Head, Bracket Head) and a change in surface treatment (Acid etching).

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Denracle Dental Abutment for Osstem GS Implant is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system: OSSTEM GS Fixture System Ø 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.

Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conjunction with specific dental implants utilizing the Dental Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. Denracle Dental Abutment for Osstem GS Implant is compatible with the following implant systems: OSSTEM GS Fixture System 04.0 mm, Ø4,5 and Ø5,0mm.

This looks like a 510(k) summary for a dental abutment, which is a medical device, not a software device. Therefore, the questions about AI performance, multi-reader multi-case studies, and ground truth establishment for software training and testing sets are not applicable.

However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

The provided document describes a "Denracle Dental Abutment for Osstem GS Implant" and focuses on demonstrating its substantial equivalence to a legally marketed predicate device (TDS Abutment for Friadent Xive - K103339). The acceptance criteria are primarily related to mechanical strength and compatibility for its intended use, rather than performance metrics for a diagnostic or AI-driven device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set:

• Sample Size for Test Set: Not explicitly stated. The document mentions "testing was conducted on a worst-case scenario" for mechanical testing, implying specific test articles were used, but the quantity isn't provided.
• Data Provenance: The testing was conducted internally by Green DenTech Co., Ltd. (the manufacturer) as part of their 510(k) submission. No information about country of origin of data or retrospective/prospective nature is applicable in the context of device mechanical and material testing.

3. Number of Experts and Qualifications for Ground Truth:

• This concept is not applicable for this type of medical device submission. Ground truth, in the context of AI, refers to expert-validated labels or diagnoses. For a dental abutment, the "ground truth" is established through engineering standards (e.g., ISO 14801) and material science principles, which are verified through objective laboratory testing.

4. Adjudication Method:

• This is not applicable. The testing involves objective measurements against established engineering standards, not subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of this device.

6. Standalone Performance Study:

• Yes, a form of "standalone" performance was effectively done in the form of the non-clinical mechanical, biocompatibility, and sterilization testing. These tests evaluate the device's inherent properties and performance against predetermined standards, independent of human interaction beyond operating the testing equipment.

7. Type of Ground Truth Used:

• The "ground truth" for this device's evaluation is based on established engineering standards (e.g., ISO 14801), material science principles, and predefined specifications for compatibility and fit. These are objective benchmarks against which the device's test results are compared.

8. Sample Size for Training Set:

• This concept is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm that undergoes machine learning training.

9. How Ground Truth for Training Set was Established:

• This concept is not applicable for the same reason as above.

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