(89 days)
The ACE Surgical Orthodontic Bone Screw System is 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. It is intended for single use only.
The ACE Surgical Orthodontic Screw System is a is a set of machined surgical grade titanium alloy (Ti-6AI-4V ELI) screws, intended for orthodontic use, constructed with a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. This head design also permits the use of the screw with the orthodontic appliances (bracket, wire, elastic head, etc.) The tip of the screw is designed available to self drilling and self-tapping, supplied in 1.2/1.5mm and 1.5/1.8mm tapered thread, both with a 3.0mm diameter head and in lengths of 6,8,10mm. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics that cleared under K951392. These screws are supplied sterile in standard Tyvek™ mylar packaging.
The ACE Surgical Orthodontic Bone Screw System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.
The provided text describes a 510(k) submission for the ACE Surgical Orthodontic Bone Screw System. This is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria through a clinical or algorithmic study in the way a diagnostic AI device might.
Therefore, many of the requested categories for AI device evaluation (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of submission.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (for Substantial Equivalence): The primary acceptance criterion for this 510(k) notification is to demonstrate that the ACE Surgical Orthodontic Bone Screw System is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
Reported Device Performance:
The submission states the following to support substantial equivalence:
| Category | Description / Performance |
|---|---|
| Intended Use | Identical to predicate devices (fixed anchorage for orthodontic appliances, temporary use). |
| Materials | Machined surgical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136 standard. Identical to predicate. |
| Technological Characteristics | Orthodontic bone screws with self-drilling/self-tapping tips, specific head design for wire/appliances. Sizes 1.2/1.5mm and 1.5/1.8mm tapered thread, 3.0mm head diameter, 6, 8, 10mm lengths. Stated as identical in materials and characteristics to predicate K951392. |
| Bench Testing | "Demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Orthodontic Screw System and the specified predicate devices." |
| Labeling | Submitted and reviewed as part of the 510(k). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on bench testing, material specifications, and comparison to predicate devices, not a clinical "test set" of patient data for performance evaluation in the context of an AI/diagnostic device.
- Data Provenance: Not applicable. The "data" here refers to design specifications, material standards (ASTM F136), and results from bench tests conducted by the manufacturer, rather than clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The evaluation is based on engineering principles, material science, and comparison to existing devices.
4. Adjudication method for the test set
- Not applicable. No clinical test set or adjudication process for diagnostic performance is described.
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 a study assessing human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical orthodontic screw, not an algorithm, and therefore doesn't have "standalone" algorithmic performance in the sense of AI.
7. The type of ground truth used
- Ground Truth: For the purpose of a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence is effectively derived from established engineering standards, material specifications, and the historical safety and effectiveness records of the legally marketed predicate devices. The bench test results serve to confirm the new device meets performance characteristics equivalent to those established standards and predicates.
8. The sample size for the training set
- Not applicable. There is no concept of a "training set" for this type of medical device submission.
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.