(45 days)
The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
The ScrewPlus Implant system consists of tapered screw-type endosseous implants with the same standard "V" thread configuration, the same 2mm of minithreads near the top of each implant, are manufactured using the same medical grade titanium alloy material and are coated with the same soluble blast media (SBM) blasted surface treatment or HA plasma sprayed. The HA coated variety of these implants are the subject of this submission.
This document is a 510(k) summary for a dental implant system (K073049). It does NOT contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on:
- Identical intended use: The ScrewPlus System Implants with HA Coating have the same intended use as the predicate implants (Zimmer Dental AdVent Dental Implant System and Implant Direct's Spectra-System).
- Nearly identical technological characteristics and materials: The new device shares the same screw-type design, thread configuration, minithreads, medical-grade titanium alloy, and surface treatment (SBM blasted or HA plasma sprayed) as the predicate devices.
The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This is a regulatory pathway that primarily compares a new device to existing ones rather than detailing performance studies with specific acceptance criteria in the way you've outlined.
Therefore, I cannot populate your requested table and information points as the provided text does not contain that type of data. The document does not describe:
- A table of acceptance criteria and reported device performance (e.g., accuracy, sensitivity, specificity).
- Sample sizes for test sets or their data provenance.
- Number/qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
§ 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.