(28 days)
The T3® Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
The T3® Pro Implants may also utilize immediate loading for these indications. The T3® Pro Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
The T3® Pro Implants with the new ZimVie Implant Packaging System. The material and design of the subject device is identical to the primary predicate device T3® Pro Implants cleared in K213672.
The ZimVie Implant Packaging System configuration, similarly to the primary predicate device, consists of a titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed in a heat-sealed outer tray, covered with a Tyvek® lid. The outer tray is placed inside a cardboard box, and gamma sterilized. The new ZimVie Packaging System has been standardized to align the packaging across all ZimVie implant families. The subject device in the new ZimVie Packaging System has a shelf-life of two (2) years.
The provided FDA 510(k) clearance letter and associated documentation for the "T3 Pro Implants- ZimVie Packaging System" (K251660) do not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/human reader performance study.
Instead, this submission is for a medical device (endosseous dental implant) and its new packaging system. The "performance data" section explicitly states that no clinical data was included in the submission for the substantial equivalence determination. The focus of the provided document is to demonstrate equivalence to a previously cleared predicate device for the dental implant itself, with the primary change being the packaging system.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance related to an AI-assisted or standalone AI system, nor can I provide details on sample size, expert adjudication, MRMC studies, or ground truth establishment, as these concepts are not discussed or relevant to the provided documentation for this specific 510(k) clearance.
The information provided describes non-clinical performance data related to the physical device and its packaging:
- Sterilization validation: Gamma irradiation sterilization to a sterility assurance level of 10^-6 according to ISO 13004 and ISO 11137.
- Aging studies: Demonstrating a shelf life of two (2) years for the implants, with packaging sterile barrier testing per ASTM F1980.
- Packaging studies: Simulated distribution and environmental conditioning per ISTA 3A and ASTM D4169.
- Biological evaluation: Leveraged from the primary predicate device, demonstrating no increased risks regarding biocompatibility. The material is Commercially Pure Titanium conforming to ASTM F67.
- MR Safety testing: Conducted according to ASTM F2503-13 on the primary predicate device (identical to the subject device) for MR Conditional determination.
- Bacterial Endotoxin Testing: Routinely performed using LAL assay in accordance with ISO 11737-3.
The acceptance criteria for this submission would primarily revolve around demonstrating that the new packaging system maintains the sterility, integrity, and safety of the dental implant for its stated shelf life, and that the dental implant itself remains identical to the previously cleared predicate device in all other aspects (materials, design, intended use, operating principle).
In summary, your request pertains to an AI/Software as a Medical Device (SaMD) study, while the provided document describes the 510(k) clearance process for a physical dental implant device and its new packaging.
§ 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.