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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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The MODUS System Self-drilling Screws are intended for use in the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dento-facial deformations. The MODUS System Self-drilling Screws are intended for use in the internal fixation in the craniofacial skeleton, secondary to trauma, reconstruction, or surgical correction of dento-facial deformations which require positional and functional stability.

The MODUS® System Self-drilling Screws are self-tapping self drilling screws for use with the cleared MODUS plates and mesh fixation components. The screws are made from CP titanium, Grade 4 or titanium alloy. The screws are available in lengths ranging from 3 mm to 8 mm and diameters ranging from 1.2 to 2.0 mm.

This document is a 510(k) Summary for the MODUS® System Self-drilling Screws, seeking clearance from the FDA. It does not describe acceptance criteria or a study proving that the device meets acceptance criteria.

Instead, it asserts substantial equivalence to predicate devices based on:

• Intended Use: The MODUS Self-drilling Screws have the same intended use as predicate devices: internal fixation in the craniofacial skeleton due to trauma, reconstruction, or surgical correction of dento-facial deformations.
• Material: The screws are composed of commercially pure Grade 4 titanium or titanium alloy, similar to predicate devices.
• Design: The design, including a tapered thread for self-drilling capability, is stated to be the same as several predicate self-drilling screws.

The FDA's letter (pages 2-3 of the provided text) confirms that the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This clearance process for medical devices often relies on demonstrating substantial equivalence to existing devices rather than requiring new clinical trials that establish acceptance criteria and prove performance against them, especially for devices and indications that are well-established.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies cannot be extracted from the provided text because these types of studies were not conducted or reported for this 510(k) submission. The basis for clearance was a comparison to predicate devices, not de novo testing against specific acceptance criteria.

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