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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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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

The Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length. It is made of Titanium alloy (Ti-6AI-4V ELI, ASTM F 136- 02A). The surface of the screw is non-treated.

The provided text describes the 510(k) summary for the OSSTEM Implant Co., Ltd.'s Orthodontic Screw. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based device.

The "device" in this context is a physical Orthodontic Screw, and the review focuses on its substantial equivalence to a predicate device, primarily through material, design, and non-clinical mechanical testing, not through performance metrics of an AI.

Therefore, many of the requested fields related to AI performance are not applicable. I will fill in the relevant available information based on the document provided.

Acceptance Criteria and Study for OSSTEM Implant Orthodontic Screw

This submission is for a physical medical device (Orthodontic Screw), not an AI/algorithm-based device. Therefore, the acceptance criteria and study detailed here focus on non-clinical performance and substantial equivalence to a predicate device, rather than AI performance metrics, ground truth establishment, or human-in-the-loop studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated for the non-clinical tests (fracture load, rotational fracture torque). These tests would typically involve a statistically relevant number of physical samples, but the specific quantity is not provided in this summary.
• Data provenance: The tests were conducted internally by OSSTEM Implant Co., Ltd. ("Osstem standard"). The country of origin for the data is implicitly Republic of Korea (where OSSTEM is based). The data is from non-clinical (laboratory) testing.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable for this type of device and testing. Ground truth for mechanical tests is established by physical measurement against engineering standards, not expert consensus.

4. Adjudication method for the test set:
Not applicable. Mechanical test results are quantitative and do not require expert adjudication in the same way clinical or image-based assessments do.

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 not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.

7. The type of ground truth used:
For the non-clinical tests (fracture load, rotational fracture torque), the "ground truth" or reference was Osstem internal standards (OS-C-0013 and OS-C-0012). For substantial equivalence, the ground truth was the characteristics of the predicate device (Super Orthodontic Screw, K062156).

8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:
Not applicable.

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