(147 days)
The Osstem Implant is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra Wide Fixture System is intended to be used in the molar region.
The SS SA Fixture is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
This document is a 510(k) Premarket Notification from Osstem Implant Co., Ltd. to the FDA for their "SS SA Fixture" dental implant. It aims to demonstrate substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics as one might see for a diagnostic AI device.
Therefore, the requested information elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and training ground truth establishment) are generally not applicable in the context of this 510(k) submission for a non-AI dental implant.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish substantial equivalence.
Here's an adaptation of the requested format based on the available information:
1. A table of acceptance criteria and the reported device performance
For a dental implant, "acceptance criteria" usually refers to meeting established standards (e.g., ISO, ASTM) and demonstrating equivalence to predicate devices, rather than specific performance metrics like sensitivity/specificity for an AI algorithm. The device performance is primarily assessed through non-clinical testing to ensure its physical and mechanical properties are comparable or superior to the predicate.
| Acceptance Criterion (Based on predicate equivalence and applicable standards) | Reported Device Performance (SS SA Fixture) |
|---|---|
| Material Composition (Pure Titanium Grade 4 per ASTM F67) | Same as Predicate: Pure Titanium Grade 4 (ASTM F67) |
| Surface Treatment (SA - Sandblasted and Acid etched) | Same as Predicate: SA surface treatment. No change from predicate. |
| Sterilization (Radiation Sterile) | Same as Predicate: Radiation Sterile. No change from predicate. |
| Shelf Life (Compared to predicate) | Same as Reference Predicate: 8 years (Primary Predicate was 5 years, Reference Predicate was 8 years). |
| Biocompatibility (As established for predicate material and processes) | No additional testing required: Material of construction and manufacturing processes are the same as predicate devices (ET/SS Implant System, K120847 and OSSTEM Implant System, K161604). |
| Bone to Implant Contact (BIC) Value (Comparable to predicate device with similar lengths) | Substantial equivalence confirmed: BIC analysis conducted for implants |
§ 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.