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EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

EquivaBone is a biocompatible bone graft substitute material consisting of Calcium Phosphate (CaP3), Carboxymethylcellulose (CMC) and Demineralized Bone Matrix (DBM). EquivaBone is supplied in a single use kit as sterile powders and hydration that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and remodels during the healing process.

The provided text describes a 510(k) premarket notification for a medical device called EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone). The primary purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device.

Regarding acceptance criteria and a study to prove the device meets these criteria, the document focuses on changes to the device's De-mineralized Bone Matrix (DBM) source and a new method for assessing osteoinductivity.

Here's a breakdown of the requested information based on the provided text:

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

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

The document does not explicitly state the sample size for the test set used in the correlation study for osteoinductive potential or for the comparison of DBM sources.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is a correlation study comparing an in vitro assay (C2C12) to an in vivo assay (athymic rat implantation) to establish a new test method.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth. The "ground truth" for the osteoinductive potential correlation study appears to be the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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 MRMC comparative effectiveness study was conducted or mentioned in the document. This device is a bone graft substitute, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a bone graft substitute, not an algorithm.

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

For the osteoinductive potential, the ground truth was based on the in vivo osteoinduction (OI) score of 1 from the athymic rat implantation model for the predicate device. For DBM source equivalence, the ground truth appears to be the established chemical composition, physical properties, and performance characteristics of the DBM from the original source (AlloSource).

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device performance or an algorithm. For the osteoinductive potential correlation study, the document describes a validation effort for a new assay method, but not a separate training set.

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

As there's no mention of a traditional "training set" in the context of a machine learning algorithm, this question is not directly applicable. The correlation study established a relationship between an in vitro assay and a previously accepted in vivo method, where the in vivo results define the benchmark for osteoinductivity.

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