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EquivaBone is an osteoinductive bone graft substitute that 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 voids or gaps may result from natural occurring bone disease, traumatic injury or surgical intervention.

EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution 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 resorb and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for ostcoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans.

The provided text is a 510(k) summary for the EquivaBone Osteoinductive Bone Graft Substitute. It does not contain any information about acceptance criteria or a study proving device performance against such criteria for AI/ML-driven medical devices.

Instead, it describes a traditional medical device (a bone graft substitute) and its regulatory submission. The performance data section states: "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void . Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices." This indicates that the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical study as would be expected for AI/ML devices.

Therefore, I cannot populate the requested tables and information. The document details:

• Device Name: EquivaBone Osteoinductive Bone Graft Substitute
• Intended Use: To fill bony voids or gaps of the skeletal system of the extremities, spine, and pelvis that are not intrinsic to the stability of the bony structure.
• Materials: Synthetic calcium phosphate, carboxymethyl cellulose (CMC), and human demineralized bone matrix (DBM).
• Predicate Devices: CaP Plus (ETEX Corporation, K063050, K080329), EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corporation, K090310), Actifuse™ (ApaTech Limited, K082575), Vitoss Bioactive Foam Bone Graft Substitute (Orthovita, K083033).
• Performance Data Mentioned: Regression testing to show changes to predicate devices do not affect risk profile, and assay for osteoinductive potential in an athymic nude mouse model for DBM.

This type of information is typical for a traditional 510(k) submission for a physical medical device, not an AI/ML clinical decision support system.

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