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Pioneer E-Matrix Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities and pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Pioneer E-Matrix Bone Void Filler is a gelatin-based bone void filler for use in repairing bony defects in the extremities and pelvis that are not intrinsic to the stability of the bony structure. The product is provided sterile, for single use only, and is supplied in granular form to be reconstituted at the time of use. A commercially available dispensing syringe and a mixing spatula are included in the product package.

The provided document is a 510(k) summary for the Pioneer E-Matrix Bone Void Filler. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert ground truth establishment, adjudication methods, or MRMC/standalone studies.

The document primarily focuses on:

• Device Description and Intended Use: Explains what the Pioneer E-Matrix Bone Void Filler is and what it's used for.
• Predicate Devices: Lists existing devices to which the Pioneer E-Matrix Bone Void Filler claims substantial equivalence.
• Substantial Equivalence Conclusion: States that comparisons and testing demonstrate substantial equivalence to other bone void fillers.
• FDA Communication: The FDA letter confirms the 510(k) clearance based on substantial equivalence, outlines regulatory requirements, and includes the official Indications for Use.

In summary, this document does not describe a study with acceptance criteria and measured performance in the way a clinical trial or algorithm validation study would. It's a regulatory document for clearance based on equivalence, not a direct performance report.

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