(65 days)
OPTEFORM® Allograft Full Disk; OPTEFORM® Allograft Partial Disk; OPTEFORM® Moldable Allograft Paste, Syringe; OPTEFORM® RT Allograft Paste; OSTEOFIL® IC Moldable Allograft Syringe; OSTEOFIL® ICM Moldable Strip; OSTEOFIL® RT ICM Moldable Allograft; RTI Allograft Paste IC; and RTI Allograft Strip IC are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, 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 remodels into the recipient's skeletal system.
These devices are bone paste products made by combining gelatin, dcmineralized bone matrix and cortical-cancellous bone chips.
The provided text is a 510(k) Summary for a medical device (bone void filler) and does not describe acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided input.
However, I can extract information related to the performance data provided:
- Non-Clinical Performance Data Supporting Substantial Equivalence Determination: Results from studies in animal models indicate that these products can be used as a bone void filler with equivalent or better healing results when compared to the predicate device. Healing was evaluated radiographically, histologically, and mechanically.
- Osteoinductivity Screening: DBM (demineralized bone matrix) and finished product were screened for osteoinductivity in a rat assay. The document notes that "Findings from an animal model are not necessarily predictive of human clinical results."
This information suggests that animal studies were conducted to assess healing and osteoinductivity, using radiographic, histologic, and mechanical evaluations. However, specific acceptance criteria, sample sizes for test sets, ground truth establishment, or details about the experts involved are not available in this document.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.