(116 days)
The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other prosthetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.
Device Function: The Amorphous Diamond Coated Screw is designed to fasten prosthetic components to implants and/or other prosthetic components. The attachment is secured by applying torque to the screw.
Scientific Concepts: Screws used to fasten prosthetic components can some times loosen. The greater the preload that is applied, the less chance there is that the screw will eventually become loose. Titanium screws with an amorphous diamond coating applied to the working length of the screw underneath the head, can be preloaded to a much greater torque than uncoated screws and thus are less likely to loosen.
Characteristics: The Amorphous Diamond Coated Screw is constructed of titanium alloy with an amorphous diamond coating applied to the working length of the screw underneath the head.
The provided text is a 510(k) summary for a medical device called the "Amorphous Diamond Coated Screw." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness or algorithm performance.
Therefore, the information you've requested (acceptance criteria, details of a study proving device adherence to criteria, ground truth, expert qualifications, sample sizes, MRMC studies, standalone performance, etc.) is not present in this 510(k) summary.
Here's why and what information is available:
- Type of Device: The device is a "Prosthetic Attachment Screw" for dental implants. This is a physical medical device, not a diagnostic or AI-driven software device.
- Regulatory Pathway: A 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing materials, design, intended use, and performance data (often mechanical and biological testing for physical devices) to show that the new device is as safe and effective as the predicate. It does not generally involve clinical trials as would be expected for a novel therapeutic or diagnostic.
- Focus of the Document: The document focuses on:
- Identifying the manufacturer and device.
- Stating the predicate device and claiming substantial equivalence.
- Describing the device and its intended use.
- Comparing the Amorphous Diamond Coated Screw to the predicate device (Steri-Oss Tiodized Screw) on characteristics like material, surfactant, geometry, screw design, intended use, packaging, and sterility.
- Stating that "Biological and mechanical test data were performed to support the indications for use," but it does not provide details of these tests, specific acceptance criteria, or the results.
Based on the provided text, I cannot complete your request because the necessary information is not included in this 510(k) summary. This document is for a physical dental implant component, not an AI/software device that would typically have the kind of performance studies you are asking about (like MRMC, standalone algorithm performance, expert ground truth adjudication).
§ 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.