(72 days)
The KLS-Martin Ortho Anchorage System are screws intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point.
This document is a 510(k) summary for the KLS-Martin Ortho Anchorage System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. Here's a breakdown of what is present and what is missing:
What is present:
- Device Description: The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point.
- Intended Use: Surgically placed in the mouth for use as an anchor for orthodontic procedures.
- Predicate Devices:
- Substantial Equivalence Argument:
- Similar in application and function to the KLS Martin Centre-Drive Drill Free Screw (K971297).
- Substantially equivalent in intended use to the Nobel Biocare Onplant Orthodontic System (K980460).
- Technological characteristics: Screws are similar to KLS-Martin Centre-Drive Drill Free Screw and are made of CP titanium or Ti-6Al-4V Titanium Alloy.
What is missing (which would be required to answer your specific questions):
- Acceptance Criteria: There are no explicit acceptance criteria mentioned for any performance metrics of the device.
- Reported Device Performance: No performance data (e.g., strength, durability, biocompatibility, clinical success rates, failure rates, etc.) is provided from any study.
- Study Details:
- No mention of any specific study (clinical, non-clinical, bench) that assesses the device's performance against criteria.
- Therefore, all related questions about sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, or training set details are not applicable as no such study is described.
In summary, this 510(k) summary is a regulatory filing asserting equivalence to existing devices, not a scientific report detailing performance testing against acceptance criteria. To find the information you requested, you would need to look for a different type of document, such as a design validation report, a clinical study report, or a comprehensive PMA application (if it were a Class III device requiring one, which it is, but this document is a 510(k) for an implant).
§ 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.