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The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.

The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components.

For specific product descriptions, please refer to individual product labels.

The provided text is a Premarket Notification (510(k)) for the Biomet 3i LLC TSX Implants. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about an AI/ML powered device, nor does it include data from a clinical study on device performance against acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.

The document explicitly states: "No clinical data were included in this submission." This means that the information needed to answer most of your detailed questions about device performance validation against specified criteria is not present in the provided text.

The closest relevant information is under "XI. Non-Clinical Testing," which describes mechanical testing (ISO 14801:2016), sterility validation, pyrogenicity testing, SEM/EDS imaging for surface assessment, and biocompatibility testing. These are non-clinical tests to show the device's physical and biological properties are equivalent to predicate devices, not performance against clinical acceptance criteria for an AI/ML algorithm.

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