(98 days)
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is intended for use in patients where orthodontic treatment has been completed. Screws are intended for single use only.
The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,
This document is a 510(k) premarket notification for the "O.A.S.I. System" (Mini Screws) by Lancer Orthodontics. It seeks to establish substantial equivalence to a predicate device, the "Dual Top Anchor Systems Screws" by Jeil Medical Corporation (K033767).
Based on the provided text, a formal study demonstrating the device meets specific acceptance criteria is not included. The document's purpose is to show substantial equivalence to an existing legally marketed device, not to present a new clinical or performance study with defined acceptance criteria.
Therefore, many of the requested items cannot be extracted directly from this document because they pertain to a type of study that was not performed or detailed here. This submission relies on a comparison of technological characteristics to a predicate device rather than presenting novel performance testing data against specific acceptance criteria.
However, I can extract information related to the comparison of technological characteristics used to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
As no specific performance study with acceptance criteria is detailed in this 510(k) submission, a table of acceptance criteria and reported device performance cannot be generated. The submission's "performance" is based on its similarity to the predicate device in the following areas:
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (vs. Predicate) |
|---|---|
| Indications For Use | Similar / Equivalent |
| Target Population | Similar / Equivalent |
| Design | Similar / Equivalent |
| Materials (specifically Titanium Grade 5 (Ti6A14V)) | Similar / Equivalent (Predicate device's material not specified here, but similarity is claimed) |
| Sterility | Similar / Equivalent |
| Biocompatibility | Similar / Equivalent |
| Anatomical Sites Where Used | Similar / Equivalent |
| Standards Met | Similar / Equivalent |
Note: The "reported device performance" in this context refers to the technological characteristics being "similar and therefore equivalent" to the predicate device, which is the basis for 510(k) clearance.
The remaining requested items (2-9) are typically associated with a performance study designed to demonstrate a device meets specific clinical or analytical endpoints. Since this document is a 510(k) submission focused on substantial equivalence through comparison of technological characteristics, most of these details are not present.
Summary of what is not present in the provided document:
- 2. Sample size used for the test set and data provenance: No test set is described.
- 3. Number of experts used to establish the ground truth for the test set and qualifications: No test set or ground truth establishment is described.
- 4. Adjudication method for the test set: No test set or adjudication process is described.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- 7. The type of ground truth used: No specific ground truth is referenced for performance testing, as the equivalence is based on technological characteristics.
- 8. The sample size for the training set: Not applicable; there is no "training set" for this type of 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.