(156 days)
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
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Fracture load test | In compliance with Osstem standard (OS-C-0013) | Non-clinical testing |
| Rotational fracture torque test | In compliance with Osstem standard (OS-C-0012) | Non-clinical testing |
| Material | Titanium alloy (Ti-6Al-4V ELI, ASTM F 136-02A) - Same as predicate | Comparison to predicate |
| Indication for Use | Fixed anchorage point for orthodontic appliances - Same as predicate | Comparison to predicate |
| Sterilization | Radiation Sterile - Same as predicate | Comparison to predicate |
| Shelf life | 5 years - Same as predicate | Comparison to predicate |
| Biocompatibility | Performed to comply with US & International regulations | Safety testing |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.