(294 days)
KJ External Implant System 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 terminal or intermediate abutment support for fixed bridgework. KJ External Implant System is for stage surgical procedures. It is intended for delayed loading.
The KJ External Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the implants has been treated with R.B.M (Resorbable Blast Media).
This document is a 510(k) premarket notification summary for the KJ External Implant System, a dental implant device. It establishes substantial equivalence to predicate devices, but it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert qualifications, etc.) that would typically be found in a study proving a device meets acceptance criteria for an AI/algorithm-based medical device.
The information provided relates to the physical and material properties of a dental implant, not to an algorithm's performance. Therefore, I cannot extract the requested information as it is not present in the provided text.
Here's why and what kind of information is provided:
Why the requested information is not present:
- Device Type: The KJ External Implant System is a physical medical device (a dental implant), not a software or AI-based device. The detailed requests about acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are primarily relevant for evaluating the performance of algorithms or diagnostic imaging devices where subjective interpretation or computational accuracy is key.
- 510(k) Summary Purpose: A 510(k) summary aims to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves comparing intended use, technological characteristics, materials, and non-clinical performance (like sterilization, shelf life, and material composition for physical devices). It rarely includes detailed clinical trial data or algorithm validation studies unless the device itself is a diagnostic algorithm or introduces novel performance claims requiring such studies.
What is provided in the document (and why it's different from your request):
- Device Description: It describes the physical characteristics of the dental implant, including its material (Titanium 6AL 4V ELI alloy), surface treatment (R.B.M), and available sizes (diameters and lengths).
- Intended Use/Indications for Use: For use in partially or fully edentulous mandibles and maxillae, supporting various restorations, and intended for delayed loading.
- Predicate Devices: The document identifies predicate devices (US SYSTEM by Osstem Implant Co., Ltd. (K062030) and Hero II/IS Dental Implant System by KJ Meditech Co., Ltd. (K121047)) to which the new device is compared for substantial equivalence.
- Non-Clinical Testing: This section mentions tests performed to demonstrate safety and performance for a physical implant:
- Sterilization validation (ISO 11137, ISO 11737-1 & -2, ISO 17665-1 & -2)
- 3-year shelf-life validation (accelerating testing)
- Chemical and SEM image analyses for residual RBM treatment (on fixtures)
Therefore, an actual table of acceptance criteria and the requested study details for an AI/algorithm device cannot be constructed from this document.
§ 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.