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Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous 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. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.

The device is a bone void filler consisting of a mineralized collagen matrix. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.

This K092046 document is a 510(k) Summary Statement for the Bi-Ostetic Foam and Putty, indicating that the device is being cleared based on substantial equivalence to predicate devices, rather than a new clinical study demonstrating specific performance metrics against acceptance criteria. Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

The document primarily focuses on:

• Intended Use: Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure, to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). It provides a bone void filler that resorbs and is replaced by the growth of new bone.
• Device Description: A bone void filler consisting of a mineralized collagen matrix (bovine fibrillar collagen component is biocompatible) providing a scaffold for new bone growth.
• Substantial Equivalence: The safety and effectiveness are supported by substantial equivalence to previously cleared predicate devices.

Missing Information:

Since this is a 510(k) substantial equivalence submission, it does not typically involve the type of detailed performance criteria, ground truth studies, or AI-specific evaluations (like MRMC or standalone performance with AI) that would be present for software or AI-driven diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to pre-existing, legally marketed devices.

Therefore, no table of acceptance criteria and reported device performance from a specific study can be extracted from this document, nor can the other requested details related to such a study.

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