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CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:

• trauma and vascular pathologies, either associated or non-associated to cranial decompression;
• removal of tumours;
• reabsorption of autologous bone;
• rejection of other prosthetic materials;
• congenital malformations.

CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics:

• macro-pores,
• interconnecting pores,
• micro-pores.
  This material is biocompatible.
  The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.

The provided text describes a 510(k) premarket notification for a medical device called "CustomizedBone Service." It focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information provided is primarily related to the device's design, material, intended use, and a minor change in fixation method.

Crucially, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of typical AI/ML medical device performance studies. The document describes a traditional medical device submission, not an AI/ML-driven device.

Therefore, I cannot extract the information required to populate the fields related to acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training data, or ground truth for training data as these concepts are not discussed in the provided text.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section mentions tests for "Stability verification of CustomizedBone Service stabilized with Cranial LOOP (L)" and "Usability of an alternative method of fixation." However, these are mechanical/usability tests for a physical implant, not performance metrics for an AI/ML algorithm.

In summary, the provided content is insufficient to answer the prompt because it describes a hardware medical device (cranioplasty plate) and not an AI/ML-driven device requiring the specified performance evaluations.

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CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge) . This device is indicated for both adult and pediatric use (for children 7 years of age and above).

CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:

• · trauma and vascular pathologies, either associated or non-associated to cranial decompression;
• · removal of tumours:
• · reabsorption of autologous bone;
• · rejection of other prosthetic materials;
• · congenital malformations.

Not Found

This document is a 510(k) clearance letter from the FDA for the "CustomizedBone Service" device. It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary (which might be a separate document). The letter primarily addresses the substantial equivalence determination and regulatory requirements for marketing the device.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets those criteria from this text. The provided document is a regulatory approval letter, not a study report.

To answer your questions accurately, I would need access to the 510(k) summary or the full submission documentation, which would describe the performance testing conducted for the "CustomizedBone Service."

Ask a specific question about this device