Search Results

CERAMENT G is a resorbable, gentamic bone void filler intended for use in defects in the extremntes of skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the standard treatment approach to bone infection and open fractures.

By eluting gentamicin, CERAMENT G can reduce the occurrence of bone infection from gentamicinsensitive microorganisms in order to protect bone healing.

CERAMENT G can augment provisional hardware to help 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 G resorbs and is replaced by bone during the healing process.

CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. It is composed of hydroxyapatite, calcium sulfate and gentamicin, and is identical to the device cleared in DEN210044.

This submission expands the device's indication to include use in patients with open fractures in need for bone void filling.

The provided text describes the 510(k) premarket notification for the CERAMENT G device. This document focuses on demonstrating substantial equivalence to a predicate device and expanding its indications for use. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the context of clinical performance demonstrating safety and effectiveness for the expanded indication compared to the standard of care.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an expansion of an existing device's indication, the "acceptance criteria" are implied by a comparison to the standard of care for the new indication (open fractures). The device performance is then measured against these implicit benchmarks.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 81 patients
• Data Provenance: Real-World Evidence ("Real World Evidence from the Manchester Cohort") from a retrospective (or prospectively collected clinical data analyzed retrospectively) consecutive series of patients treated by the Manchester Orthoplastic Group in the United Kingdom.
  • Country of Origin: United Kingdom (Manchester)
  • Retrospective/Prospective: The phrasing "consecutive series of 81 patients... treated by the Manchester Orthoplastic Group between June 2013 and April 2021" suggests a retrospective analysis of existing clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not explicitly provided in the document. The study refers to "Real World Evidence from the Manchester Cohort" and clinical outcomes. While these outcomes are likely assessed by medical professionals, their specific roles, number, or qualifications for establishing "ground truth" (e.g., confirming infection, assessing union) are not detailed in this submission summary. The study reference (Henry et al., 2023) would likely contain more details on this.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the document. Given it's a retrospective analysis of clinical outcomes, a formal adjudication method (like 2+1 or 3+1) by independent experts is less common than in prospective clinical trials designed with such rigorous review protocols. The assessment would have been done as part of standard clinical practice.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study evaluated the clinical performance of CERAMENT G as used in actual patient cases and compared its outcomes to published standard of care rates, rather than having multiple readers evaluate cases with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a bone void filler (a physical implantable product), not an AI or software algorithm. The concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the test set was based on clinical outcomes data from real-world patient treatment. This includes:

• Diagnosis of deep infection
• Assessment of limb salvage
• Assessment of bone union

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is an implantable bone void filler, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The "training data" for the device's development would refer to pre-clinical testing, material characterization, and prior clinical experience that led to its initial clearance.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided for the reasons stated above (not an AI/ML device). For the development of the physical implant, ground truth would have been established through laboratory bench testing, animal studies, and prior clinical data for its initial indications, assessing properties like dissolution, pH, strength, antimicrobial activity, and biocompatibility.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device

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 gans in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defect smav he 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 an injectable ceramic bone substitute material intended for bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate and 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 injection into a bone void/gap. 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/gap, under visual inspection or under radiographic monitoring, with the use of the accompanying injection devices.

The provided text describes a 510(k) premarket notification for a medical device (CERAMENT™ BONE VOID FILLER) and includes information about its intended use, description, and regulatory classification. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any details about performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document primarily focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device (K073316) and refers to general pre-clinical testing without providing details of the tests, their results, or how they relate to specific acceptance criteria.

Therefore, I cannot fulfill most of your request from the provided text. I can only provide the information that is explicitly stated in the document.

Here's what can be extracted based on the document's content:

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

• Not available in the provided text. The document states: "Extensive in vitro and in vivo testing has shown that the CERAMENT™|BONE VOID FILLER (A0210 –12 ) meets the requirements of all relevant standards for Calcium Salt Bone Voilt VOID Fillers." However, it does not specify what those "requirements" (acceptance criteria) are, nor does it provide a table of performance results against them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not available in the provided text. This type of information is typically relevant for AI/ML device studies, which is not what this 510(k) submission describes.

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

• Not available in the provided text.

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 / Not available in the provided text. This device is a bone void filler, not an AI diagnostic or assistive device that would involve human readers.

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

• Not applicable / Not available in the provided text. This device is a physical bone void filler, not an algorithm.

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

• Not applicable / Not available in the provided text. For a bone filler, "ground truth" would relate to successful bone formation and resorption, typically assessed through histology, imaging, and clinical outcomes in animal or human studies. The document only vaguely refers to "extensive in vitro and in vivo testing" without detailing the methodology or metrics used.

8. The sample size for the training set

• Not available in the provided text.

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

• Not available in the provided text.

Summary of what the document does provide:

• Device: CERAMENT™ BONE VOID FILLER (A0210-12)
• Intended Use: As a ceramic bone void filler for orthopedic applications, specifically for gaps and voids not intrinsic to the bony structure in extremities, pelvis, and spine (during open surgery). It resorbs and is replaced by bone.
• Predicate Device: CERAMENT™ BONE VOID FILLER (A 0210), 510(k) number K073316.
• Demonstration of Safety and Effectiveness: Through "extensive in vitro and in vivo testing," which is stated to show it "meets the requirements of all relevant standards for Calcium Salt Bone Void Fillers." This is the basis for its substantial equivalence determination. However, no specific details of these tests or their results are provided.

Ask a specific question about this device

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.

Ask a specific question about this device