(109 days)
The US/SS/GS System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The US/SS/GS Fixture System is for one and two stage surgical procedures. It is not for immediate load.
The US/SS/GS System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
This 510(k) submission (K073247) for the OSSTEM Implant Co., Ltd. US/SS/GS System is for an endosseous dental implant. This document is a summary of the 510(k) submission and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It does not contain the details of a study with specific acceptance criteria and performance data in the format requested.
Therefore, I cannot populate the table and answer the specific questions about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth methodologies, as this information is not present within the provided text.
The document states:
- "The US/SS/GS System has been subjected to safety, performance, and product validations prior to release."
- "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations."
However, it does not provide the details of these validations or tests, nor does it specify numerical acceptance criteria or the reported performance against them.
In a 510(k) submission for a device like a dental implant, substantial equivalence is often demonstrated through:
- Comparison of materials, design, indications for use, and technological characteristics to predicate devices.
- Results from mechanical testing (e.g., fatigue strength, static strength) to ensure the device meets recognized standards.
- Biocompatibility testing.
- Dimensional and tolerance analysis.
The provided text only asserts that these tests and validations were done and that the device is substantially equivalent to predicate devices (K062030, K062051, K063861). It does not provide the numerical data, study design, or expert review details that would allow me to fill in the requested information.
§ 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.