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The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System is intended for use in trauma and reconstructive procedures of the craniofacial skeleton, including fracture of the cranium, infant craniofacial surgery (i.e. craniosynostosis, congenital malformations), pediatric reconstructive procedures, reconstructive procedures of the cranium, craniotomy flap fixation.

The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System devices are the sterile, single-use bone plates, meshes and screws manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Plates, meshes and screws are provided with various shapes and sizes typical of other marketed fixation devices.

Used properly, in the presence of adequate immobilization, the OSTEOTRANS" MX Bioabsorbable Bone Fixation System devices maintain accurate alignment of bone fractures and osteotomies.

The provided text describes the OSTEOTRANS™-MX Bioabsorbable Bone Fixation System and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.

Instead, the document focuses on:

• Intended Use Statement: Listing the anatomical regions and conditions for which the device is indicated.
• Device Description: Explaining the materials (hydroxyapatite and poly-L-lactide HA/PLLA composites) and general form (plates, meshes, screws).
• Summary of Technology: Stating that the device has the "same technological characteristics (i.e., design and material) when compared to the predicate devices" and that "Performance data demonstrate that the OSTEOTRANS™-MX Bioabsorbable Bone Fixation System has the requisite strength and favorable degradation profile to provide sufficient and sustained bone fixation for intended uses."

The document relies heavily on demonstrating substantial equivalence to previously cleared predicate devices (K010352, K992355, K971870, K992905, K003549, K062819, K061881) rather than presenting new clinical study data with defined acceptance criteria. The statement about "Performance data" is generic and does not refer to a specific study detailed in this 510(k) summary.

Therefore, I cannot populate the requested table or answer the questions regarding sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, or ground truth establishment based on the provided text. The 510(k) process for this device appears to rely on demonstrating similarity to already approved devices.

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The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, which includes the facial cranium, mid-face, maxilla and mandible.

The OSTEOTRANS™-MX Bioabsorbable Bone Fixation System devices are the sterile, single-use bone plates, meshes and screws manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Plates, meshes and screws are provided with various shapes and sizes typical of other marketed fixation devices.

Used properly, in the presence of adequate immobilization, the OSTEOTRANSMAN Bioabsorbable Bone Fixation System devices maintain accurate alignment of bone fractures and osteotomies.

The provided text is a 510(k) summary for a medical device (OSTEOTRANS™-MX Bioabsorbable Bone Fixation System) and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, often through performance data on strength and degradation. It does not contain the kind of detailed information typically found in a clinical study report that would address the acceptance criteria for algorithm performance, sample sizes for test/training sets, expert qualifications, or MRMC studies for an AI/ML device.

Therefore, I cannot provide the requested information from the given text. The text does not describe an AI/ML device or a study involving acceptance criteria for its performance.

Ask a specific question about this device