(497 days)
The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.
The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is an 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, removed after orthodontic treatment has been completed. Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. Orthodontic Fixation Screw [Smart Anchor Miniscrew] is made of Titanium Alloy (T)-6AL-4V), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The head of the screw is through hole head type. The head of the Orthodontic Fixation Screw [Smart Anchor Miniscrew] is designed to apply various orthodontic tools. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, the design accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.). The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is available in in diameters of 1.2, 1.4, 1.6, 1.8, and 2.0mm and lengths of 8 and 10mm. The Orthodontic Fixation Screws with a diameter of 1.4mm and greater are also available in a 6mm length version.
The provided text is a 510(k) summary for the "Orthodontic Fixation Screw [Smart Anchor Miniscrew]". This document describes the device and its equivalence to predicate devices, focusing on bench testing rather than clinical studies or AI-based performance.
Therefore, the requested details regarding acceptance criteria for AI/ML performance, study types (MRMC, standalone), ground truth establishment, expert adjudication, and sample sizes for training/test sets are not present in this document. The document confirms that no clinical performance testing was necessary for the demonstration of substantial equivalence.
The acceptance criteria provided in this document are primarily for the physical and mechanical properties of the orthodontic screw, demonstrating substantial equivalence to a predicate device.
Here's what can be extracted from the provided text regarding acceptance criteria and the study:
Acceptance Criteria and Device Performance (Based on Bench Testing for Substantial Equivalence)
| Acceptance Criteria Category | Specific Test/Parameter | Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance (Implicit from Equivalence Claim) |
|---|---|---|---|
| Material Biocompatibility | Cytotoxicity (ISO 10993-5) | Meets applicable requirement of ISO 10993 | Performed, meets standards for Titanium Alloy (ASTM F136) |
| Hypersensitivity (ISO 10993-10) | Meets applicable requirement of ISO 10993 | Performed, meets standards for Titanium Alloy (ASTM F136) | |
| Intracutaneous Reactivity (ISO 10993-10) | Meets applicable requirement of ISO 10993 | Performed, meets standards for Titanium Alloy (ASTM F136) | |
| Acute Systemic Toxicity (ISO 10993-11) | Meets applicable requirement of ISO 10993 | Performed, meets standards for Titanium Alloy (ASTM F136) | |
| Local Effect after Implantation (ISO 10993-6) | Meets applicable requirement of ISO 10993 | Performed, meets standards for Titanium Alloy (ASTM F136) | |
| Sterilization | Moist Heat Sterilization Validation | Validated per ISO 17665-1 and ISO 17665-2 | Validated per ISO 17665-1 and ISO 17665-2 (Non-Sterile, Steam sterilized by user) |
| Mechanical Performance | Axial Pullout Strength Test | Demonstrated substantial equivalence to predicate (K161335) | Comparative bench test conducted using ASTM 543-13; differences in diameter addressed with reference device. Performance not quantified but deemed equivalent. |
| Torsional Strength Test | Demonstrated substantial equivalence to predicate (K161335) | Comparative bench test conducted using ASTM 543-13; performance not quantified but deemed equivalent. | |
| Insertion-Removal Torque Test | Demonstrated substantial equivalence to predicate (K161335) | Comparative bench test conducted using ASTM 543-13; performance not quantified but deemed equivalent. | |
| Fracture Load Test (for Ø 1.2mm) | Demonstrated substantial equivalence to reference device (K161197) with 1.2mm diameter | Conducted for Ø 1.2mm, performance not quantified but deemed equivalent. | |
| Rotational Fracture Torque Test (for Ø 1.2mm) | Demonstrated substantial equivalence to reference device (K161197) with 1.2mm diameter | Conducted for Ø 1.2mm, performance not quantified but deemed equivalent. | |
| Dimensional/Visual | Visual and Dimension Check | Conforms to manufacturer's declared design characteristics | Tested and conformed. |
| Risk Management | Risk Analysis | Conducted based on ISO 14971:2012 | Analysis conducted based on ISO 14971:2012. |
Study Details:
The document describes non-clinical performance testing to demonstrate substantial equivalence, not a study involving AI/ML performance, human readers, or clinical outcomes.
- Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML. For bench testing, samples of the device were used. No information on the number of devices tested is explicitly provided. The provenance of the data is from in-house bench testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and biocompatibility tests is established by physical measurements and laboratory analyses against established standards (ASTM, ISO).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical performance testing was necessary for the demonstration of substantial equivalence."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is an orthodontic screw, not an algorithm.
- The type of ground truth used:
- For biocompatibility: Laboratory test results against ISO 10993 standards.
- For mechanical tests: Physical measurements (e.g., force, torque) against ASTM 543-13 and manufacturer's specifications, compared to predicate device performance.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the provided FDA 510(k) clearance letter and summary pertain to a physical medical device (an orthodontic screw) and its demonstration of substantial equivalence through non-clinical (bench) testing, not through clinical or AI/ML performance studies. Therefore, many of the requested data points related to AI/ML device validation are not relevant to this document.
§ 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.