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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 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.

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