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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.

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