(224 days)
The T-FIT is designed to provide a fixed anchorage point for attaching orthodontic appliances, facilitating the orthodontic movement of teeth. It is used temporarily and removed upon completion of the orthodontic treatment for use in patients aged 12 and older. The screws are intended for single use only.
The T-FIT is designed to serve as a fixed anchorage point for attaching orthodontic appliances to facilitate the movement of teeth during orthodontic treatment. The system is intended for temporary use and is removed once treatment is complete. The T-FIT is available in thread diameters Ø1.4 mm, 1.6 mm, and 2.0 mm and thread lengths of 6.0 mm, 8.0 mm, 10.0 mm, 12.0 mm, and 14.0 mm. Thread lengths of 12.0 mm and 14.0 mm are only available with Ø2.0 mm diameter models. All screws are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). The T-FIT is provided non-sterile and is intended for single use only. Additionally, the T-FIT is designed to be used with commonly available dental surgical instruments.
The FDA 510(k) Premarket Notification for the T-FIT device does not contain information typically associated with acceptance criteria and studies for AI/ML-driven devices. The T-FIT is an orthodontic anchorage screw, a physical medical device, and the submission focuses on its material, dimensions, and mechanical performance compared to a predicate device.
Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to this specific submission.
The document describes non-clinical performance testing for a physical device, primarily focusing on mechanical and biocompatibility aspects, as well as sterilization:
1. A table of acceptance criteria and the reported device performance:
The document describes performance testing conducted according to recognized standards, rather than providing a table of specific acceptance criteria and reported performance values. The objective of these tests is to demonstrate substantial equivalence to the predicate device.
| Test Type | Standard Applied |
|---|---|
| Torsion Test | ISO 19023:2018, "Dentistry – Orthodontic Anchor Screws" & ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Anchor Screw" |
| Torque Test | ISO 19023:2018, "Dentistry – Orthodontic Anchor Screws" & ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Anchor Screw" |
| Pull-out Test | ISO 19023:2018, "Dentistry – Orthodontic Anchor Screws" & ASTM F543-17, "Standard Specification and Test Methods for Metallic Medical Anchor Screw" |
| Biocompatibility | ISO 10993-1:2018, ISO 7405:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-23:2021, ASTM F543-17 |
| Sterilization | ISO 17665-1:2006, ISO/TS 17665-2:2009, AAMI/ANSI ST79:2017 |
| MRI Compatibility | Scientific rationale and published literature (Woods, Terry O., et al., 2019) |
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 does not specify sample sizes for the mechanical tests, nor does it provide details on data provenance as these are physical device tests, not clinical data sets. The tests are "nonclinical," meaning they were conducted in a laboratory setting.
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):
Not applicable. Ground truth, in the context of expert review, is not relevant for the mechanical and biocompatibility testing of a physical medical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used for establishing ground truth in clinical imaging or diagnostic studies, which is not the nature of the tests described 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:
Not applicable. This type of study is relevant for AI-assisted diagnostic devices, not for a physical orthodontic screw.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The T-FIT is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for mechanical testing would be the physical properties measured under standardized conditions, and for biocompatibility, it would be the results from specified biological assays and tests against established safety limits for materials.
8. The sample size for the training set:
Not applicable. The T-FIT is a physical device; 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.