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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 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.

Not Found

This document, K193547, is a 510(k) premarket notification decision letter for the "CustomizedBone Service" device. It is not an imaging AI device, but rather a preformed nonalterable cranioplasty plate. As such, the information you've requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample sizes, expert ground truth, MRMC studies) is not present in this document.

The document primarily focuses on the FDA's determination of substantial equivalence for this medical device to existing predicate devices, its intended use, and regulatory compliance.

Therefore, I cannot provide the requested information about acceptance criteria and study data for an AI/ML device based on this specific input.

Ask a specific question about this device

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

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 above 13 years of age).

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

I am sorry, but the provided text from the FDA 510(k) summary for the "CustomizedBone Service" does not contain information about the acceptance criteria and the study that proves the device meets those criteria.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses the regulatory classification, general controls, and compliance requirements for the device.

To address your request, information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics would typically be found in the 510(k) Summary or 510(k) Premarket Notification itself, specifically in sections detailing the non-clinical and clinical performance data submitted to the FDA. The provided text is the FDA's response letter rather than the detailed submission from the manufacturer.

Therefore, I cannot extract the requested information from the given text.

Ask a specific question about this device

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 above 13 years of age).

CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:

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

Not Found

This document is a 510(k) clearance letter for the "CustomizedBone Service," a preformed nonalterable cranioplasty plate. The letter itself does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary. It confirms the device's substantial equivalence to predicate devices.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and the study that proves the device meets them from the provided text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on a demonstration of substantial equivalence, which often relies on comparison to a legally marketed predicate device rather than on new extensive clinical trials for performance acceptance criteria in the same way a PMA or a de novo device might.

To provide the requested information, I would need access to the actual 510(k) submission summary or detailed study reports from the manufacturer, which are not present in this regulatory clearance letter.

Ask a specific question about this device