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Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). The bone graft can be used as a bone filler for orthopedic surgery. It is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The composite material is gradually resorbed and replaced by bone tissues. Bicera® Resorbable Bone Substitute is supplied sterile in various shapes and sizes.

The provided text is a 510(k) summary for a medical device (Bicera® Resorbable Bone Substitute). It details the device's classification, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence based on non-clinical testing.

However, the provided document does not contain any information regarding clinical studies, human subject data, or AI/ML-driven device performance evaluations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results (effect size of human readers with/without AI)
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states that "Discussions of Non-Clinical Tests for Determination of Substantial Equivalence" were performed, including physical and chemical property evaluations, biocompatibility tests (in vitro and animal implantation studies), and pyrogen/endotoxin testing. It confirms that these non-clinical tests showed the device to be similar in effectiveness to predicate devices.

In summary, this document describes a traditional 510(k) submission based on non-clinical data, not a study evaluating an AI/ML device against specific performance criteria with human readers or clinical data.

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