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CERAMENT BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.

CERAMENT BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, posterolateral spine (only during open surgery in spine), and intervertebral disc space. These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone. When used in intervertebral body fusion procedures, CERAMENT BONE VOID FILLER must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

CERAMENT BONE VOID FILLER resorbs and is replaced by bone during the healing process.

CERAMENT BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT BONE VOID FILLER can be drilled and screws can be placed through it.

CERAMENT BONE VOID FILLER is composed of hydroxyapatite, calcium sulfate hemihydrate, and calcium sulfate dihydrate, and it identical to the device cleared in K201535. This submission expands the device's indication to include use in the intervertebral space.

The provided text is a 510(k) premarket notification approval letter for the Cerament Bone Void Filler. This document does not describe a study involving an AI/software device that requires acceptance criteria, a test set, expert readers, or MRMC studies.

Instead, it pertains to a medical device (a bone void filler) and its substantial equivalence to predicate devices, focusing on:

• Its material composition (hydroxyapatite, calcium sulfate hemihydrate, and calcium sulfate dihydrate).
• Its indications for use (filler for gaps and voids, including intervertebral disc space, with specific conditions).
• Performance aspects like sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and bench performance, which were leveraged from a previous clearance (K201535).
• A "robust analysis of bone grafting materials in the prior posterolateral spine fusion studies" is mentioned, but this refers to a biological material's performance in an animal model, not the performance of an AI algorithm or a software device.

Therefore, the information requested in your prompt (acceptance criteria for a device, test set details, expert ground truth, MRMC study, standalone performance, etc.) is not present in the provided text as it is not relevant to the type of device (a bone void filler) being discussed.

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CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.

CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.

CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.

CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.

CERAMENT| BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains iohexol as a radio-opacification enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo.

By combining hydroxyapatite and calcium sulfate, an optimal balance is achieved between implant resorption rate and bone ingrowth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone ingrowth and gives long term structural support to the newly formed bone.

The ceramic bone graft substitute is placed into the bone defect under direct visualization or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate filling the bone defect.

When fully set in vivo, CERAMENT | BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.

This document describes the regulatory submission for CERAMENT BONE VOID FILLER, a medical device, and its acceptance criteria as defined by the FDA. However, it does not describe acceptance criteria for an AI device's performance or a study proving an AI device meets those criteria.

Therefore, I cannot fulfill the request as it pertains to an AI device. The provided text is a 510(k) submission for a bone void filler and does not contain information about AI device performance testing, ground truth establishment, or clinical study methodologies for AI.

The closest relevant information is a statement about the device meeting "pre-determined acceptance criteria identified in the Design Control Activities Summary," but the document does not provide details about those specific acceptance criteria beyond general biocompatibility and mechanical properties for a bone void filler. It also mentions "Performance Testing" was previously provided, but again, the specifics of these tests and their results are not detailed in this submission.

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CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.

CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.

CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.

CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate hemihydrate and sintered hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for percutaneous injection into a bone void. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone.

The ceramic bone substitute material is injected into the bone void in a percutaneous procedure, under visual inspection or under radiographic monitoring, with the use of the accompanying injection device.

The provided text describes a medical device, CERAMENT™ BONE VOID FILLER, and its 510(k) summary for market clearance. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically understood for AI/ML-based medical devices.

The text primarily focuses on:

• Device Description: What the device is made of and how it works.
• Intended Use: The medical conditions and applications for which the device is designed.
• Predicate Device Comparison: It states that the device is "equivalent to the predicate device in intended use, technological characteristics and principles of operation."
• Regulatory Clearance: The FDA's decision of substantial equivalence.

The only mention of testing is "Extensive in vitro and in vivo testing has shown CERAMENT™|BONE VOID FILLER to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed CERAMENT™|BONE VOID FILLER to be safe and effective." This is a general statement and does not provide specific acceptance criteria or details of a study with performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document. The questions regarding sample size, data provenance, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are also unanswerable based on this text.

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Cerament™ is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Cerament™ is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone. Cerament™ provides a bone void filler that resorbs and is replaced by bone during the healing process.

Cerament™ is an injectable bone mineral substitute material intended for stabilization of fractured osteoporotic bone void. The material consists of a powder and a liquid component. The major constituents of the powder component are calcium sulphate hemihydrate and hydroxyl apatite and the liquid component is the radio-contrast agent Iohexol. Mixing of the powder and liquid components results in a viscous mixture suitable for percutaneous injection into the fractured bone void. During resorption of the calcium sulfate dihydrate, the hydroxy apatite remains intact providing osteoconductive support for the in-growth of new bone, which gradually replaces the resorbed calcium sulfate dihydrate.

The bone mineral substitute material is injected into the bone void in a percutaneous procedure with the use of an accompanying injection device. Prior to injection, the powder and liquid components of the substitute material are mixed in a mixing container. The substitute material is injected into the bone void during careful radiographic inspection until the bone void is filled as judged from the radiographic image.

This document describes a pre-market notification (510(k)) for the Cerament™ Bone Void Filler, a medical device. The information provided focuses on the device's characteristics and its substantial equivalence to predicate devices, rather than a clinical study establishing specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove it cannot be directly extracted from the provided text.

However, based on the text, here's what can be gathered regarding "acceptance criteria" through the lens of regulatory submission and information about the device:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics from a specific study. Instead, it states:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable/not provided. The submission focuses on substantial equivalence, pre-clinical testing, and material properties, not a specific clinical test set for performance metrics.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. The text only mentions "extensive in vitro and animal testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/not provided. This information would typically be part of a clinical study, which is not detailed in this 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a bone void filler, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a bone void filler, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the "extensive in vitro and animal testing," the ground truth would likely be based on established scientific methods for evaluating material properties, biocompatibility, resorption rates, and osteoconductivity in relevant animal models. Specific details are not provided.

8. The sample size for the training set:

Not applicable/not provided. The concept of a "training set" is usually associated with machine learning or AI algorithm development, which is not relevant to this device.

9. How the ground truth for the training set was established:

Not applicable.

In summary:

The provided text is a 510(k) summary, aiming to demonstrate substantial equivalence to predicate devices. It relies on the established safety and efficacy of similar materials and functions, supported by general statements about in vitro and animal testing. It does not contain the detailed clinical study data, specific acceptance criteria, or ground truth establishment methods that would be present in a submission for a novel device requiring such proof of performance. The "acceptance criteria" here are broad regulatory requirements and comparisons to existing devices, rather than quantitative performance metrics from a specific human-subjects study.

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