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The OsseoSpeed™ 4.0S - 6 mm is intended to be used to replace missing masticatory functional units (tecth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained.

The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed 4.0S - 6 mm is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.

OsseoSpeed 4.0S - 6 mm is a threaded, root-form dental implant intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.

The provided 510(k) summary for the OsseoSpeed™ 4.0S - 6 mm dental implant (K063779) primarily details the device's administrative information, classification, intended use, design, and its substantial equivalence to predicate devices.

It does not contain information about acceptance criteria, the specific studies proving performance against acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study results as typically required for AI/algorithm-based medical devices.

This document is a premarket notification for a traditional medical device (a dental implant), not a software or AI-driven device. As such, the types of performance evaluations and acceptance criteria relevant to AI/ML models are not found in this submission.

Therefore, I cannot populate the requested table and answer the study-related questions based on the information provided in the 510(k) summary. The summary focuses on equivalence to existing devices and general safety and effectiveness for a physical implant, rather than the performance metrics of an algorithmic diagnostic or predictive tool.

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