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MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities, spine and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

MicroFuse™ Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse™ is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse™ is provided in a variety of shapes and sizes, in the form of granules, sheets, and pre-formed blocks. MicroFuse™ granules are designed to be gently packed into contained voids or defects. MicroFuse™ sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse™ blocks are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.

The provided text is a 510(k) summary for the MicroFuse™ Bone Void Filler, which details the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with specific acceptance criteria as might be found in a PMA (Pre-Market Approval) application or a clinical trial report for drug approval.

Therefore, I cannot provide the requested information based on the input text. The document confirms that the device was found substantially equivalent to predicate devices, allowing it to be marketed, but it does not detail specific performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to a performance study.

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MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

MicroFuse™ Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse™ is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse™ is provided in a variety of shapes and sizes, in the form of granules, sheets, and pre-formed blocks. MicroFuse™ granules are designed to be gently packed into contained voids or defects. MicroFuse™ sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse™ blocks are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.

The provided text is a 510(k) summary for the MicroFuse™ Bone Void Filler. This document describes the device and its intended use, and states that it is "substantially equivalent" to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, expert involvement, or ground truth establishment.

The 510(k) process for medical devices like the MicroFuse™ Bone Void Filler primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as another device already on the market. While manufacturers conduct various tests (e.g., biocompatibility, mechanical testing) to support safety and performance claims, the 510(k) summary itself typically summarizes the basis of equivalence rather than presenting detailed study results that would satisfy the specific points requested in your prompt (acceptance criteria table, sample sizes, expert-derived ground truth, etc.).

Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and a definitive study proving the device meets them. The document focuses on regulatory approval through substantial equivalence, not on the detailed performance study data you've requested.

Ask a specific question about this device