(22 days)
The Replace™ Scalloped Margin Implant System is an implant with a scalloped coronal margin, designed for single stage or two stage surgical procedures. The Replace™ Scalloped Margin Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.
The Replace " Scalloped Margin Implant System is an implant with a scalloped coronal margin designed to mimic the contours of the alveolar ridge. The implant is designed for esthetic applications where the alveolar ridge and the soft tissues are relatively intact.
The available diameters will be 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with lengths of 10 mm, 13 mm and 16 mm. The titanium implant body will be available with an HA coating on the root form portion.
The provided text describes a medical device submission (K021584) for the "Replace™ Scalloped Margin Implant System" to the FDA. This document is a 510(k) premarket notification used for medical devices that are substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) would.
Therefore, based on the provided text, there is no information available regarding:
- A table of acceptance criteria and reported device performance.
- A specific study proving the device meets acceptance criteria.
- Sample size for a test set or its data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI.
- A standalone algorithm performance study (the device is a physical dental implant, not an AI algorithm).
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The provided text only contains the following relevant information:
Device Name: Replace™ Scalloped Margin Implant System
Indications for Use: The Replace™ Scalloped Margin Implant System is an implant with a scalloped coronal margin, designed for single stage or two stage surgical procedures. The Replace™ Scalloped Margin Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.
Legally Marketed Predicate Device: Replace™ HA Coated Implant (K962845)
Regulatory Action: The FDA determined that the device is substantially equivalent to the legally marketed predicate device for the stated indications for use.
In summary, this document is a regulatory approval notice for a dental implant based on substantial equivalence, not a clinical study report detailing performance against specific acceptance criteria.
§ 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.