(197 days)
The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
This submission includes threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12º from orthogonal to the implant). The Straight and Co-Axis implants are each provided in two diameters, 4.0 mm (actual major diameter 4.07 mm tapering to 2.6 mm), and 4.7 mm (actual major diameter 4.70 mm tapering to 3.13 mm), in one prosthetic diameter (3.575 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.
This submission also includes: a Cover Screw (one design/size); Healing Abutments in three diameters (3.7, 4.5, and 5.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Cosmetic Abutments in straight (0°), 12°, and 24° angled engaging designs for single-unit restorations; Passive Abutments with a plastic burn-out component, in one size and two designs (engaging); Compact Conical Abutments in straight (0°), 20°, and 30° angled designs for multi-unit restorations; and abutment screws.
All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar. The remainder of the implant (the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634. The Cover Screw and all abutments (except Compact Conical) are manufactured from unalloyed titanium conforming to ASTM F67. The Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or gold-platinum alloy. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K163634 and K163060.
This 510(k) summary is for a dental implant system (Provata Implant System), not a software-driven AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, its performance study details, or ground truth establishment.
Specifically:
- No Acceptance Criteria Table: The document describes the device's design, materials, and comparison to predicate devices, but does not present a table of acceptance criteria and performance metrics typically associated with AI/ML device validation (e.g., sensitivity, specificity, AUC).
- No AI/ML Performance Study: The "Performance Data" section states, "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility... engineering analysis; dimensional analysis; sterilization validation... bacterial endotoxin... sterile barrier shelf life... and static and dynamic compression-bending according to ISO 14801. No clinical data were included in this submission." This explicitly indicates no clinical or reader study was performed for this device as it is physical hardware.
- No Ground Truth Establishment: Since no clinical data or AI/ML model performance is being evaluated, there is no mention of ground truth, expert opinions, or adjudication methods.
Therefore, I cannot provide a response with the requested information based on the provided text.
§ 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.