(272 days)
The KJ ZIRCONIA Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. It is for delayed loading.
KJ ZIRCONIA Implant System is a dental implant system made of ZIRCONIA intended to be surgically placed in the bone of the upper or lower jaw arches. It is one piece type implant which the implant and the abutment are manufactured as one piece. It offers two types: BL type and BS type, and the difference is only in the length of the abutment part.
This document is a 510(k) Premarket Notification from the FDA for a dental implant system. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting performance data from a clinical or algorithm-based study for an AI/ML device. Therefore, it does not contain the information needed to answer your request about acceptance criteria and study proving performance for an AI/ML device.
Here's why the document doesn't provide the requested information:
- Device Type: The "KJ ZIRCONIA Implant System" is a physical medical device (a dental implant), not an AI/ML software device.
- Regulatory Pathway: A 510(k) submission for this type of device typically demonstrates equivalency to existing predicate devices based on design, materials, and intended use, supported by non-clinical testing (e.g., sterilization, biocompatibility, mechanical properties). It does not usually involve clinical performance studies in the way an AI/ML diagnostic or prognostic device would.
- Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, test sets, ground truth establishment by experts, or MRMC studies, which are all pertinent to evaluating AI/ML product performance.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details) from this document as it pertains to an AI/ML device.
§ 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.