(96 days)
Alpha Bio Orthodontic Fixation Screw System® are intended to provide 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.
Alpha Bio Orthodontic Fixation Screw System® OFS, OFSR consists of titanium alloy Gr-5 mini thread self tapping implants, are available with 1.6 and 2mm diameter and 8, 10, 12 length.
This submission (K063770) is for a dental device, specifically the Alpha-Bio Tec® Orthodontic Fixation Screw System. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized performance standards and material specifications, rather than clinical performance studies with acceptance criteria, ground truth, or human reader comparisons typically associated with AI/software devices.
Therefore, most of the requested information regarding acceptance criteria, study design elements (sample size, data provenance, expert adjudication, MRMC, standalone performance), and ground truth establishment is not applicable to this type of device submission.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: No specific numerical "acceptance criteria" for clinical performance are stated in this document. Instead, acceptance is based on compliance with recognized standards and demonstration of substantial equivalence to a predicate device. The performance is assessed against these standards and the predicate.
- Reported Device Performance: The document states that "Safety and performance testing" was conducted and that "The Alpha-Bio Tec® System is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues." However, the specific results of these performance tests are not detailed in this summary. Instead, compliance with the following standards is asserted:
| Acceptance Criteria (Compliance with Standards/Predicate) | Reported Device Performance (Claimed Compliance) |
|---|---|
| ISO 7405:1997 (Biocompatibility) | Complies |
| F136-02a: 2004 (Titanium Alloy Spec) | Complies |
| ASTM F1350-02 (Stainless Steel Wire Spec) | Complies |
| ISO 13402:1995 (Resistance against autoclaving, corrosion etc.) | Complies |
| UL 544 (1998) (Medical and Dental Equipment) | Complies |
| Substantial Equivalence to Osteomed Orthodontic Screw System L.P. (K031936) | Alpha-Bio Tec® is substantially equivalent in intended use, indications, technological characteristics, performance, and user interface. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission does not describe a "test set" in the context of a clinical performance study with patient data. The evaluation relies on laboratory testing against standards and comparison to a predicate device's established safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of "ground truth" is not established for this device, as it's not an AI/diagnostic software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for this device's acceptance is its physical and chemical properties meeting established engineering and biocompatibility standards, and its functional equivalence to a legally marketed predicate device.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
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.