Search Results

The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
• Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
• Immediate and early loading for all indications, except in single tooth situations on implant shorter than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The proposed PrimeTaper EV Dental Implants are endosseous dental implants, which are manufactured from commercially pure titanium (Grade 4). The implant surface is blasted, and acid etched. The dental implants are intended to be surgically placed in the bone of the mandible and maxilla to replace missing teeth in order to restore chewing function. The proposed PrimeTaper EV Dental Implants have a root form shape with a self-tapping thread design. The coronal portion of the implant has a minute threading (MicroThread™). The residual implant body has macro threads. The proposed implants are available in the diameters 3.6, 4.8, 5.4 mm and in the lengths 6.5, 8, 9, 11, 13, 15, 17 mm. The proposed PrimeTaper EV Dental Implants incorporate a conical implant - abutment connection interface with indexing option (EV Connection), which is identical to the internal connection of the predicate OsseoSpeed Plus (K120414) implants. The PrimeTaper EV Dental Implants are intended to be used in combination with prosthetic components with the conical EV connection (cover screws, healing abutments, cement-retained abutments and screw-retained abutments), which were previously cleared for use with the OsseoSpeed Plus Dental Implant System (K120414, K163350, K183079 and K111287). Dental implant abutments are intended to be used in the upper or lower jaw used for supporting tooth replacements to restore chewing function. No new Abutments are being proposed as part of this submission. The PrimeTaper EV Dental Implants are provided sterile by electron-beam irradiation.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context you specified (AI/ML device performance).

The text is a 510(k) summary for a PrimeTaper EV Dental Implant, which is a physical medical device (an endosseous dental implant). The document details the device description, indications for use, comparison to predicate devices, and non-clinical as well as clinical performance data to demonstrate substantial equivalence to previously cleared devices.

Therefore, I cannot extract the following information that you requested:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

These specific points are relevant to AI/ML-enabled devices and their evaluation, not to the traditional medical device (dental implant) described in the provided document.

Ask a specific question about this device