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OsseoSpeed™ Narrow is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. 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 when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.

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 Narrow 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.

Osseospeed Narrow is a self tapping, 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.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a dental implant called "OsseoSpeed™ Narrow," primarily focusing on its administrative information, device description, intended use, and substantial equivalence to marketed devices. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes for test sets, data provenance, or ground truth establishment.
3. Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
4. Details on training set size or how its ground truth was established.

The document is a regulatory submission for market clearance, not typically a detailed report of performance studies with specific statistical metrics against predefined acceptance criteria.

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