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DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.
All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments are to be sent to a Dental Direkt validated milling center for manufacture.
DD Prefab abutments, for the Zimmer Biomet 3i Certain 3.4mm implant bodies, and DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral and mandibular central/lateral incisors only.

The DD Solid Connect® CAD/CAM Abutments consist of the following parts: DD Prefab, DD Ti-Base 2CUT and DD Ti-Base 2CUT noLock. The DD Solid Connect CAD/CAM Abutments are designed and made to individually fit the individual requirements for each patient.
DD Prefab attach directly to the following dental implants:

• Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0)
• Nobel Biocare: Nobel Active (3.5 NP, 4.3/5.0 RP)
• Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)
• Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0)
• Straumann: Bone Level (3.3, 4.1/4.8)
• Straumann: SynOcta (4.8, 6.5)
• Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7)
• Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5)
• Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4)
• Zimmer Biomet 3i: Certain (3.4, 4.1/5.0)
  DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach directly to the following dental implants:
• Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0)
  The DD Prefab blanks are prefabricated components for the metal-cutting production of individualized and one-piece abutments using CAD/CAM technology.
  The Ti-Bases (DD Ti-Base 2CUT / DD Ti-Base 2CUT no-Lock) are used as part of a two piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD-CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
  All three implant components, the DD Prefab, the DD Ti-Base 2CUT and the DD Ti-Base 2CUT noLock are delivered each with an implant screw (DD Implant screw).

The provided text is a 510(k) summary for a dental device (DD Solid Connect® CAD/CAM Abutments). It details the device's indications for use, technical characteristics, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study involving an AI/Machine Learning component with acceptance criteria, expert ground truth, or MRMC studies.

The "Performance data" section refers to:

• Fatigue testing according to ISO 14801 and FDA guidance for dental implants/abutments. This is mechanical testing to assess durability.
• Biocompatibility testing for cytotoxicity according to ISO 10993-5. This assesses the material's safety in contact with biological systems.
• Sterilization validation according to ISO 17665-1, ISO 11737-1, and ISO 11737-2. This verifies the sterilization process.
• Reverse engineering dimensional analysis using OEM implant bodies, OEM abutments, and OEM abutment screws. This is to ensure compatibility and fit.

These are standard engineering and biocompatibility tests for medical devices, not performance studies for AI/ML algorithms predicting or classifying medical conditions.

Therefore, I cannot extract the requested information (acceptance criteria, details of an AI/ML study, sample sizes for AI/ML test/training sets, expert ground truth, MRMC studies, or standalone performance) from the provided text as it pertains to the approval of a physical dental abutment and not an AI/ML diagnostic or predictive device.

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