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Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.

The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:

The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.

The provided text is a 510(k) summary for a medical device (Immediate Molar Implants) and does not contain information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria.

The document explicitly states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, non-clinical testing (fatigue, MR compatibility, pull-out tests, surface area analysis, sterilization, biocompatibility, shelf life), and contractual agreements for compatible components.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria using clinical or performance data, as this information is not present in the provided text. The document describes a dental implant, not an AI or software-based device that would typically have acceptance criteria presented in the manner requested.

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Nobel Biocare's Molar Implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The Molar Implants are indicated for single or multiple unit restorations in the molar region. The Molar Implants can be used in splinted or non-splinted applications. The Molar Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Nobel Biocare's Molar Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The Molar Implants are similar in design to the NobelSpeedy, Groovy, TiUnite, and NobelActive Internal Connection Implants. Like these implants, the Molar Implants are manufactured from commercially pure titanium. The implants utilize the TiUnite surface treatment and have the Groovy groove design feature.

The provided text describes a 510(k) summary for a dental implant, not a medical device with acceptance criteria for performance against a specific condition or disease, or a study to prove such performance. Therefore, I cannot extract the requested information like expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission focuses on establishing substantial equivalence to previously cleared devices based on material, design, and intended use. The "acceptance criteria" in this context would primarily relate to meeting regulatory standards and demonstrating similarity to predicate devices, rather than performance metrics for diagnostic or therapeutic accuracy.

Therefore, I am unable to provide a response to the prompt as medical devices without AI functionality and performance criteria are not included in this document.

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