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The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.

The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
MATERIALS: Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.

I am sorry, but the provided text is a 510(k) K233419 FDA clearance letter and related summary for a dental device called "GBR System". This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

It does not contain information about acceptance criteria for a study proving device performance, nor details about a study that would meet such criteria. Therefore, I cannot extract the requested information from this document.

The document discusses:

• Non-clinical tests: Biocompatibility, Insertion Torque, Fracture Torque, Pull-out tests, sterilization validation, and MRI compatibility. These are primarily engineering and material characterization tests, not clinical studies with acceptance criteria for device performance in patients.
• Comparison to predicate devices: This is done to establish substantial equivalence, not to prove that the device meets specific performance acceptance criteria from a clinical study.

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Yxoss CBR® is used for reconstruction of alveolar bone deficits prior to placing a dental implant, shaping alveolar bone and as a support to the augmented bone volume in the regeneration of bone defects that may include:

• · extraction sites
• · horizontal and/or vertical augmentation of the alveolar ridge
• · reconstruction of bone defects in the maxillofacial area

Yxoss CBR is a titanium scaffold, which will be surgically inserted over bone defects as a volume support for contouring newly formed bone over a bone defect. The titanium scaffold is held in place to the existing bone with standard titanium screw(s). The following screws are compatible with the Yxoss CBR device system (informational purposes only, not devices subject to this sub-mission, K192747): Synthes 1.3mm self-drilling screws, K983485, and Salvin Dental 1.5mm Tent-ing Screws, K161857. Yxoss CBR thus stabilize the bone graft in the defect area and specifies the shape of the bone to be augmented.

The Yxoss CBR may be used in a one-stage approach with simultaneous placement of a dental implant. The Standard Yxoss scaffold (without integrated implant positioning) is used to cover over the simultaneously placed bone level dental implant with cover screw. The Standard Yxoss scaffold is explanted after healing occurs, leaving in place the dental implant.

In a two-stage approach, the dental implant will be placed after revascularization of the augmented bone. In a two-stage approach, there are two options available:

• . Standard Yxoss scaffold (without integrated implant positioning)
• . Backward Yxoss scaffold (with integrated implant positioning)

For the two-stage approach, the Standard Yxoss scaffold will be removed before placing the dental implant. For the Backward Yxoss scaffold using the two-stage approach, the pre-holes are used as guide for drilling the seat before inserting the dental implant chosen by the surgeon. Then, the Backward Yxoss scaffold will be explanted.

The device is manufactured by SLS (Selective Laser Sintering) additive manufacturing.

The provided text is a 510(k) Summary for the Yxoss CBR® device, detailing its comparison to a predicate device for FDA clearance. It focuses on the device's design, materials, and non-clinical testing, rather than a study on an AI/ML algorithm's performance. Therefore, I cannot extract information pertaining to AI/ML algorithm acceptance criteria, test sets, expert adjudication, MRMC studies, standalone performance, or training set details as these are not discussed in the provided document.

The document primarily describes a medical device (a titanium scaffold for bone regeneration) and its regulatory clearance process, not a software or AI/ML product.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving an AI/ML device meets them based on the provided text.

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