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The Bio2 CLM•BG Bioactive Scaffold is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bioactive Scaffold is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

The Bio2 Technologies implants are bone void fillers in the shape of cylinders, blocks and wedges. The devices are osteoconductive, bioactive, bone void fillers. The implants are made from a fiber based bioactive glass. The material can be drilled and tapped, and screws can be placed through it. The device structure allows tissue infiltration between the bioactive glass fibers. The fibers then are slowly absorbed and replaced by new bone tissue during the healing process. The cylinders, blocks and wedges are provided sterile and are intended for single use.

The provided text is a 510(k) summary for the Bio2 CLM.BG Bioactive Scaffold, a bone void filler device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not contain the specific details required to fulfill all sections of your request regarding acceptance criteria and a study proving those criteria are met for a device that uses AI or reports performance metrics like sensitivity, specificity, or AUC.

The document focuses on:

• Substantial Equivalence: Comparing the device's characteristics (e.g., osteoconductive, bioactive, resorbable bioactive glass, radiopaque) and performance to existing predicate devices (Bio2 CLM.BG Bioactive Scaffold K142463, Synthes chronOS K013072, Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty K073303).
• Biocompatibility Testing: Stating compliance with ISO-10993.
• In Vitro Bioactivity Testing: Mentioning compliance with ISO 23317:2012 and the material forming a surface apatite layer when submerged in simulated body fluid.
• In Vivo Animal Studies: Stating that the device achieves bony healing in a critical defect model, confirmed with radiographs, histology, and histomorphometry.

Based on the provided text, I can answer some of your questions, but many will be missing as the document does not describe the kind of performance study you are asking for (e.g., related to AI-driven diagnostics with metrics like sensitivity and specificity).

Here's the breakdown of what can and cannot be answered:

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

Not available in the provided text in the requested format. The document describes compliance with standards and equivalence to predicates, not specific numerical acceptance criteria with corresponding performance metrics like sensitivity or specificity.

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

• Sample size for the test set: Not explicitly stated for the in vivo animal studies. It mentions "critical size defects were filled" and rabbit femurs were evaluated, suggesting an animal model, but not the number of animals or defects.
• Data provenance: For the in vivo animal studies, "rabbit femurs" are mentioned, indicating an animal model study, not human data. Country of origin is not specified.
• Retrospective or prospective: The animal studies would typically be prospective, but this is not explicitly stated.

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 applicable or not mentioned. The ground truth for the animal study appears to be based on objective scientific methods like X-ray, histology, histomorphometry, SEM, and EDX, rather than human expert interpretation of images for diagnosis.

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

Not applicable or not mentioned. This typically relates to expert consensus for ground truth establishment in diagnostic studies, which is not what is described here.

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

No. This is not an AI-based diagnostic device. The study described is an animal model for bone healing, not a human reader study.

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

No. This is not an algorithmic device.

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

For the in vivo animal studies: Radiographs, histology, histomorphometry, SEM (Scanning Electron Microscopy), and EDX (Energy Dispersive X-ray Spectroscopy). This constitutes a combination of imaging, microscopic evaluation, and elemental analysis of the bone tissue.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

In summary, the provided document details a substantial equivalence claim for a physical medical device (bone void filler) based on material properties, in vitro testing, and in vivo animal studies. It does not provide the type of performance metrics, study designs, or ground truth establishment relevant to an AI/ML-driven diagnostic device.

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